Musculoskeletal Bibliography

PURPOSE: Provide a current review of the literature concerning the epidemiology and risk factors for injuries in runners.

DATA SOURCES: The information in this paper is taken from a review of articles and book chapters (Source: PubMed and MEDLINE, years covered 1966-2006).

CONCLUSIONS: Understanding the precise causative nature of risk factors in running populations remains a challenging task. Comparison of various works in the literature is impeded by large variations in injury definition, subject population and study design. Weekly running volume continues to be considered a strong risk factor, however more work is needed to determine whether it is the absolute volume, or the increase in volume that is deleterious. Recent research has provided greater insight into the risks that previous injury and lack of full rehabilitation may play in recreational runners starting a training program. Variables related to excessive rear-foot eversion and pronation are frequently sited in combination with the incidence of specific injuries; however, the role of impact characteristics remains in debate. Isokinetic research of hip muscle function is helping to link our understanding of lower extremity kinematics, but requires more research to be proven as a causative factor. Future research in joint coupling and functional training of the complete lower extremity will be beneficial in implementing preventative interventions for running populations.

OBJECTIVE: to evaluate the efficacy of capsular distension combined with intraarticular glucocorticoid injections and immediate physical therapy in the treatment of adhesive capsulitis.

METHOD: a prospective open study of patients with adhesive capsulitis. Clinical and radiological criteria was used for diagnosis. Clinical evaluation was realized before treatment, at the end of the treatment, after 1 month, 3 months and 6 months. It carried on: the measure of pain and handicap intensity by an Visual Analogue Scale, the algo-functional score of Constant, the measure of passive articular mobilities. We ended in a success of the treatment when the visual analogue scale of handicap < 30, the score of Constant >70, the passive abduction >90 and the external rotation (RE) >45 degrees.

RESULTS: 19 patients were included, mean aged 56 years with capsular retraction evolving on average for 8.5 months. The parameters of evaluation of pain function and handicap improved significantly since the end of treatment. This improvement continued until 6 months after the treatment. Earning in articular amplitudes was significant since the end of treatment for forward extension and internal rotation. However, the improvement in abduction and internal rotation was significant only at 3 months. In spite of this early significant improvement in external rotation, 6 patients had an important limitation of the RE (<20 degrees). A subacromial bursography with steroid injection was proposed to them because subacromial bursa is almost consistently involved by retraction. Only, 4 patients among them accepted it. Out come was favorable in every case with a external rotation >45 degrees at I month of the treatment. The rate of success which was only 47.3% at the end of the treatment, is crossed in 73.6% at 1 month and reaches 89.4% at 6 months.

CONCLUSION: The therapeutic association capsular distension, intraarticular steroid injections and physical therapy allows to shorten the course of adhesive capsulitis. Burso-infiltration seems to be effective as therapeutic complement in case of persistence of an articular limitation.

OBJECTIVE: The goal of this study was to determine the benefits of a functional retraining programme (with or without daily isokinetic reinforcement of the trunk muscles) in patients with lower-back pain.

METHOD: Two groups of 30 patients took part in the study. The control group (CG) underwent a four-week reconditioning program in a day hospital, whereas a second interventional group (IG) additionally performed daily isokinetic training of the trunk muscles. Three evaluations were carried out: before hospitalization (T1), immediately after hospitalization (T2) and three months postrehabilitation (T3).

RESULTS: We observed an improvement in each parameter after rehabilitation, regardless of the group. A decrease in the DALLAS scores revealed a reduced impact of lower-back pain on the patients' lives. Pain experienced fell by 24%, analgesic treatment was significantly decreased (CG: -53%; IG: -56%), muscle endurance was improved (quadriceps: +30%, abdominal muscles: +20%, paraspinal muscles: +23%, quadratus lumborum: +33%) and the patients were more supple, as revealed by a decrease in the finger-to-ground distance (at T1, CG: 12.9+/-6.1cm; IG: 13.6+/-5.5 cm at T1; CG: 2.2+/-5.4 cm; IG: 2.8+/-5.1cm at T2). The sole difference for CG and IG at T2 resulted from an improvement in the performance of the trunk extensor muscles, which was significantly greater in the IG (CG: +14%; IG: +20%). Three months after rehabilitation, the benefits were still present for the two groups and, indeed, were even greater for certain parameters.

CONCLUSION: Regardless of the protocol, the patients improved in both physical and psychological terms and these improvements were maintained over a short period, at least. Our results confirmed that one functional recovery programme is not superior to another for patients with lower-back pain.

BACKGROUND: Carpal tunnel syndrome is one of the major health problems of workers who perform tasks entailing intense manual stress and repetitive movements of the upper limbs. The implementation of regulations and social changes, as well as the incorporation of women into the working world bring to bear the need of ascertaining whether any changes have taken place in the pattern of occurrence of this syndrome and in the factors conditioning the same. The objectives of this study are to know the frequency with which this syndrome occurs in the province of Alicante, to discover the work-related characteristics of those individuals affected thereby, to analyze the procedure followed for treatment and rehabilitation and to delve into the situation of those affected upon their return to work.

METHODS: Descriptive, cross-sectional study. The population studies was comprised of all those workers for whom an occupational disease report was remitted to the Safety and Health Commission within the 1996-2004 period.

RESULTS: A total of 266 reports of occupational disease due to carpal tunnel syndrome were filed. The incidence rate was 4.2 cases per 100,000 workers. A total of 62.8% of the cases were females, 25% of whom were under 30 years of age. The average length of employment at the company was 132.3 months.

CONCLUSIONS: The risk factors most often mentioned are performing repetitive movements and activities requiring manual strength.

AIM: The aim of our study is to evaluate the efficacy of joint distension during arthrography followed by an intra articular corticosteroid injection.

METHODS: This procedure associated to a physical therapy started immediately after joint distension and performed during 3 months in the treatment of 20 patients suffering from adhesive capsulitis of the shoulder were assessed.

RESULTS: Patients were evaluated on D 90:90% of them have regression of pain, 70% have an improvement of deficiency and ranges of motion of the shoulder. Adhesive capsulitis of the shoulder is a disabling pathology but, generally, with good evolution. It is a clinical diagnosis.

CONCLUSION: Joint distension associated to physical therapy has an interest in treatment because of therapeutic and antalgic effect and also restoration of range of movement.

BACKGROUND: Surgical and nonsurgical treatments of Achilles tendon ruptures are available. Nonsurgical treatment using immobilization does not have the varying degrees of infection as seen with surgical procedures, but it frequently is linked to muscle atrophy, weakness, and higher rates of rerupture than surgical treatment. This study reports the results of 64 patients with Achilles tendon ruptures treated surgically and with early mobilization.

METHODS: Surgery of the ruptured tendon involved dividing the proximal stump into two separate strands and the distal stump into a single strand. The repair was advanced to a V-Y formation, and nonabsorbable sutures were used for repair. After wound closure, an early mobilization rehabilitation program was initiated, which consisted of wearing a moveable ankle brace for 4 to 6 weeks in 0 to 15 degrees of dorsiflexion and 10 weeks of regular exercises.

RESULTS: All 64 patients resumed normal activities in an average of 3.3 months regardless of whether the rupture was acute or chronic. Tendons healed with no reruptures. There were 13 complications, all wound infections, which healed when treated with antibiotics. The infection rate dropped markedly when wounds were inspected and dressings changed 1 week postoperatively, instead of at 2 weeks.

CONCLUSION: Surgery combined with early mobilization reduces range of motion loss, increases blood supply, and reduces the degree of muscle atrophy that typically occurs after Achilles tendon rupture, thereby decreasing the time to resumption of normal activities. Applying tension to the tendon also improved strength of the calf muscles and improved ankle movement. The main concern with early mobilization is rerupture, but this was lessened by patients carefully following the weightbearing and early mobilization protocols. The results of this study strengthen the argument to employ early mobilization rehabilitation after surgical repair.

BACKGROUND: Many patients suffer patellar instability that may relate to transient patellar tracking abnormalities.

OBJECTIVE: To develop and test a technique to measure dynamic patellar tracking.

STUDY DESIGN: Controlled laboratory and in vivo study.

METHOD: A functional knee brace was modified to allow an ultrasound transducer to be mounted laterally to the femur, following the path of the patella during knee movement. An ultrasound system was used to measure patellar mediolateral position parallel to the femoral transepicondylar axis. Ten subjects with no patellar instability were studied to obtain patellar tracking and accuracy data.

RESULTS: The interobserver and intraobserver reproducibility ranged from 0.2 +/- 0.1 mm to 1.0 +/- 0.5 mm. The accuracy of the ultrasound measurement was checked against magnetic resonance imaging and was 0.6 +/- 1.9 mm. The patella moved medially then laterally from extension to flexion when sitting. Squatting and stepping produced a more lateral path, without the initial medial translation. The patella was more lateral during knee extension than during flexion.

CONCLUSIONS: This novel method for measurement of dynamic patellar mediolateral tracking was found to have good intraobserver and interobserver reproducibility, and the measurements matched closely with those obtained from magnetic resonance imaging reconstructions of static patellar positions. Some preliminary data for tracking in 3 activities were obtained from 10 normal knees.

BACKGROUND: Although conventional non-pharmacological and pharmacological treatments for insomnia are effective in many people, alternative therapies such as acupuncture are still widely practiced. However, it remains unclear whether the existing evidence is rigorous enough to support its use.

OBJECTIVES: To determine the efficacy and safety of acupuncture in people with insomnia. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, Dissertation Abstracts International, CINAHL, AMED (the Allied and Complementary Medicine Database), TCMLARS (Traditional Chinese Medical Literature Analysis and Retrieval System), National Center for Complementary and Alternative Medicine, the National Institute of Health Clinical Trials Database, the Chinese Acupuncture Trials Register, the Trials Register of the Cochrane Complementary Medicine Field, from inception to 2006, and the sleep bibliography, which is available at www.websciences.org/bibliosleep. We searched reference lists of retrieved articles, and contacted trial authors and experts in the field for information on ongoing/completed trials. SELECTION CRITERIA: Randomised controlled trials evaluating any form of acupuncture involving participants of any age with any type of insomnia were included. Included trials compared acupuncture with placebo or sham or no treatment, or acupuncture plus other treatments compared with the same other treatments. Trials that compared only acupuncture methods or compared acupuncture alone against other treatments alone were excluded, since they did not yield the net effect of acupuncture. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed quality according to a set of criteria for risk of selection bias, performance bias, attrition bias and detection bias. Relative risk (RR) and standardised mean difference (SMD) with 95% confidence intervals were used for binary and continuous outcomes respectively. Data were combined in meta-analyses (on an intention-to-treat basis), where more than one trial without significant clinical heterogeneity presented the same outcome.

MAIN RESULTS: Seven trials met the inclusion criteria. The studies included 590 participants with insomnia, of whom 56 dropped out. Participant age ranged from 15 to 98 years, and the duration of insomnia varied from 6 months to 19 years. Co-existing medical conditions contributing to insomnia included stroke, end-stage renal disease and pregnancy. Apart from conventional needle acupuncture, different variants of acupuncture such as acupressure, auricular magnetic and seed therapy, and transcutaneous electrical acupoint stimulation (TEAS) were evaluated. Meta-analysis was limited because of considerable heterogeneity between comparison groups and between outcome measures.Based on the findings from individual trials, the review suggested that acupuncture and acupressure may help to improve sleep quality scores when compared to placebo (SMD = -1.08, 95% CI = -1.86 to -0.31, p=0.006) or no treatment (SMD -0.55, 95% CI = -0.89 to -0.21, p=0.002). TEAS also resulted in better sleep quality score in one trial (SMD = -0.74, 95% CI = -1.22 to -0.26, p=0.003). However, the efficacy of acupuncture or its variants was inconsistent between studies for many sleep parameters, such as sleep onset latency, total sleep duration and wake after sleep onset. The combined result from three studies reporting subjective insomnia improvement showed that acupuncture or its variants was not more significantly effective than control (RR = 1.66, 95% CI = 0.68 to -4.03) and significant statistical heterogeneity was observed. Only one study reported an adverse event, with one out of 16 patients (6.3%) withdrawing from acupuncture because of pain.

AUTHORS' CONCLUSIONS: The small number of randomised controlled trials, together with the poor methodological quality and significant clinical heterogeneity, means that the current evidence is not sufficiently extensive or rigorous to support the use of any form of acupuncture for the treatment of insomnia. Larger high quality clinical trials employing appropriate randomisation concealment and blinding with longer follow-up are needed to further investigate the efficacy and safety of acupuncture for the treatment of insomnia.

BACKGROUND: Neck pain is one of the three most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are the perceptions of benefits. Acupuncture has been used as an alternative to more traditional treatments for musculoskeletal pain. This review summarizes the most current scientific evidence on the effectiveness of acupuncture for acute, subacute and chronic neck pain.

OBJECTIVES: To determine the effects of acupuncture for individuals with neck pain.

SEARCH STRATEGY: We searched CENTRAL (2006, issue 1) and MEDLINE, EMBASE, MANTIS, CINAHL from their beginning to February 2006. We searched reference lists and the acupuncture database TCMLARS in China.

SELECTION CRITERIA: Any published trial using randomized (RCT) or quasi-randomized (quasi-RCT) assignment to the intervention groups, either in full text or abstract form, were included.

DATA COLLECTION AND ANALYSIS: Two reviewers made independent decisions for each step of the review: article inclusion, data abstraction and assessment of trial methodological quality. Study quality was assessed using the Jadad criteria. Consensus was used to resolve disagreements. When clinical heterogeneity was absent, we combined studies using random-effects meta-analysis models.

MAIN RESULTS: We did not find any trials that examined the effects of acupuncture for acute or subacute pain, but we found 10 trials that examined acupuncture treatments for chronic neck pain. Overall, methodological quality had a mean of 2.3/5 on the Jadad Scale. For chronic mechanical neck disorders, there was moderate evidence that acupuncture was more effective for pain relief than some types of sham controls, measured immediately post-treatment. There was moderate evidence that acupuncture was more effective than inactive, sham treatments measured immediately post-treatment and at short-term follow-up (pooled standardized mean difference (SMD) -0.37, 95% confidence interval (CI) -0.61 to -0.12). There was limited evidence that acupuncture was more effective than massage at short-term follow-up. For chronic neck disorders with radicular symptoms, there was moderate evidence that acupuncture was more effective than a wait-list control at short-term follow-up.

AUTHORS' CONCLUSIONS: There is moderate evidence that acupuncture relieves pain better than some sham treatments, measured at the end of the treatment. There is moderate evidence that those who received acupuncture reported less pain at short term follow-up than those on a waiting list. There is also moderate evidence that acupuncture is more effective than inactive treatments for relieving pain post-treatment and this is maintained at short-term follow-up.

OBJECTIVES: To study the analgesic effect of acupuncture and placebo acupuncture and to explore whether the type of the placebo acupuncture is associated with the estimated effect of acupuncture.

DESIGN: Systematic review and meta-analysis of three armed randomised clinical trials.

DATA SOURCES: Cochrane Library, Medline, Embase, Biological Abstracts, and PsycLIT. Data extraction and analysis Standardised mean differences from each trial were used to estimate the effect of acupuncture and placebo acupuncture. The different types of placebo acupuncture were ranked from 1 to 5 according to assessment of the possibility of a physiological effect, and this ranking was meta-regressed with the effect of acupuncture.

DATA SYNTHESIS: Thirteen trials (3025 patients) involving a variety of pain conditions were eligible. The allocation of patients was adequately concealed in eight trials. The clinicians managing the acupuncture and placebo acupuncture treatments were not blinded in any of the trials. One clearly outlying trial (70 patients) was excluded. A small difference was found between acupuncture and placebo acupuncture: standardised mean difference -0.17 (95% confidence interval -0.26 to -0.08), corresponding to 4 mm (2 mm to 6 mm) on a 100 mm visual analogue scale. No statistically significant heterogeneity was present (P=0.10, I(2)=36%). A moderate difference was found between placebo acupuncture and no acupuncture: standardised mean difference -0.42 (-0.60 to -0.23). However, considerable heterogeneity (P<0.001, I(2)=66%) was also found, as large trials reported both small and large effects of placebo. No association was detected between the type of placebo acupuncture and the effect of acupuncture (P=0.60).

CONCLUSIONS: A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

PURPOSE: There is still a lack of evidence about the beneficial effects of ultrasound (US) intervention for the management of soft tissue problems. Thus, this study was designed to assess the effectiveness of US over a placebo intervention when added to other physical therapy interventions and exercise in the management of shoulder disorders. SUBJECTS AND

METHODS: Forty patients who were diagnosed by ultrasonography or magnetic resonance imaging to have a periarticular soft tissue disorder of the shoulder were randomly assigned to either a group that received true US (n=20; mean time since onset of pain=8.7 months, SD=8.8, range=1-36) or a group that received sham US (n=20; mean time since onset of pain=8.1 months, SD=10.8, range=1-42). Besides true or sham US (10 minutes), superficial heat (10 minutes), electrical stimulation (15 minutes), and an exercise program (15-30 minutes) were administered to both groups 5 days each week for 3 weeks.

RESULTS: Subjects showed within-group improvements in pain, range of motion, Shoulder Disability Questionnaire scores, and Health Assessment Questionnaire scores with the intervention, but the differences did not reach significance when compared between the groups.

CONCLUSION: The results suggest that true US, compared with sham US, brings no further benefit when applied in addition to other physical therapy interventions in the management of soft tissue disorders of the shoulder.

BACKGROUND: Basic musculoskeletal knowledge is essential to the practice of medicine. A validated musculoskeletal cognitive examination was given to medical students, residents, and staff physicians in multiple disciplines of medicine to assess the adequacy of their musculoskeletal medicine training.

METHODS: The examination was given to 334 volunteers consisting of medical students, residents, and staff physicians. Analysis of the data collected and comparisons across disciplines were performed.

RESULTS: The average cognitive examination score was 57%. Sixty-nine participants (21%) obtained a score of >/=73.1%, the recommended mean passing score. Of the sixty-nine with a passing score, forty (58%) were orthopaedic residents and staff physicians with an overall average score of 94%. Differences in the average scores for the orthopaedic residents compared with all other specialties were significant (p < 0.001). The average score was 69% for the 124 participants who stated that they had taken a required or an elective course in orthopaedics during their training compared with an average score of 50% for the 210 who had not taken an orthopaedic course (p < 0.001). When the scores of those in orthopaedics were excluded, the average score for the participants who had taken an orthopaedic course was 59%; this difference remained significant (p < 0.001).

CONCLUSIONS: Seventy-nine percent of the participants failed the basic musculoskeletal cognitive examination. This suggests that training in musculoskeletal medicine is inadequate in both medical school and nonorthopaedic residency training programs. Among the nonorthopaedists, scores were significantly better if they had taken a medical school course or residency rotation in orthopaedics, suggesting that a rotation in orthopaedics would improve the general level of musculoskeletal knowledge.

BACKGROUND: Adhesive Capsulitis (AC) affects patient of all ages, and stretching protocols are commonly prescribed for this condition. Dynamic splinting has been shown effective in contracture reduction from pathologies including Trismus to plantar fasciitis. The purpose of this study was to examine the efficacy of dynamic splinting on patients with AC.

METHODS: This controlled, cohort study, was conducted at four physical therapy, sports medicine clinics in Texas and California. Sixty-two patients diagnosed with Stage II Adhesive Capsulitis were grouped by intervention. The intervention categories were as follows: Group I (Control); Group II (Physical Therapy exclusively with standardized protocols); Group III; (Shoulder Dynasplint system exclusively); Group IV (Combined treatment with Shoulder Dynasplint and standardized Physical Therapy). The duration of this study was 90 days for all groups, and the main outcome measures were change in active, external rotation.

RESULTS: Significant difference was found for all treatment groups (p < 0.001) following a one-way ANOVA. The greatest change with the smallest standard deviation was for the combined treatment group IV, (mean change of 29 degrees ).

CONCLUSION: The difference for the combined treatment group was attributed to patients' receiving the best PT combined with structured "home therapy" that contributed an additional 90 hours of end-range stretching. This adjunct should be included in the standard of care for adhesive Capsulitis. TRIAL REGISTRATION: Trial Number: NCT00873158.

STUDY DESIGN: Inception cohort study.

OBJECTIVE: To provide the first reliable estimate of the 1-year incidence of recurrence in subjects recently recovered from acute nonspecific low back pain (LBP) and to determine factors predictive of recurrence in 1 year.

SUMMARY OF BACKGROUND DATA: Previous studies provide potentially flawed estimates of recurrence of LBP because they do not restrict the cohort to those who have recovered and are therefore eligible for a recurrence.

METHODS: We identified 1334 consecutive patients who presented to primary care with acute LBP; of these 353 subjects recovered before 6 weeks and entered the current study. The primary outcome measure was recurrence of LBP in the next year. Specifically, an episode of recurrence was defined in 2 ways: recall of recurrence at the 12-month follow-up and report of pain at the 3- or 12-month follow-up. Risk factors for recurrence were assessed at baseline. Pain intensity was assessed at 6 weeks, 3 months, and 12 months and recurrence at 12 months. Factors that could plausibly affect recurrence were chosen a priori and evaluated using a multivariable regression analysis.

RESULTS: Recurrence of LBP was found to be much less common than previous estimates suggest, ranging from 24% (95% CI = 20%-28%) using "12-month recall" definition of recurrence, to 33% (95% CI = 28%-38%) using "pain at follow-up" definition of recurrence. However, only 1 factor, previous episode(s) of LBP, was consistently predictive of recurrence within the next 12 months (odds ratio = 1.8-2.0, P = 0.00-0.05).

CONCLUSION: This study challenges the assumption that the majority of subjects will have a recurrence of LBP in a 1-year period. After the resolution of an episode of acute LBP, about 25% of subjects will have a recurrence in the next year. It is difficult to predict who will have a recurrence within the next year.

PURPOSE: To identify the structure of the iliotibial tract at knee level, as well as its insertions, layer arrangement, and relationship with other structures of the lateral region of the knee and to compare the findings with available literature.

METHODS: Ten detailed anatomic dissections were performed by using incisions as recommended by the literature in fresh cadaver knees identifying the iliotibial tract components.

RESULTS: The authors observed an iliotibial tract arrangement in superficial, deep, and capsular-osseous layers. Insertions have been described as follows: at linea aspera, at the upper border of the lateral epicondyle, at the patella, and at Gerdy's tibial tuberculum and across the capsular-osseous layer.

CONCLUSIONS: The iliotibial tract (ITT) has important interconnections to the femur, the patella, and the lateral tibia; the iliopatellar band joins the ITT to the patella through the superficial oblique retinaculum and the lateral femoropatellar ligament, and the ITT capsular-osseous layer presents differentiated fibers in an arched arrangement that borders the femoral condyle and inserts laterally to the Gerdy's tubercle. CLINICAL RELEVANCE: The iliotibial tract can be considered as an anterolateral knee stabilizer, particularly its capsular-osseous layer, which, together with the anterior cruciate ligament, constitutes a functional unit forming a spatial "horseshoe" form. The detailed description of the structures forming iliotibial tract plays an important role in the study of knee instabilities. Its important tibial, femoral, and patellar connections are described so that better understanding of tibial femoral instability on the lateral side as well as patellofemoral instability can be achieved and mechanisms of repair can be conceived.

BACKGROUND: Recent approaches to outcome measurement involving Computerized Adaptive Testing (CAT) offer an approach for measuring disability in low back pain (LBP) in a way that can reduce the burden upon patient and professional. The aim of this study was to explore the potential of CAT in LBP for measuring disability as defined in the International Classification of Functioning, Disability and Health (ICF) which includes impairments, activity limitation, and participation restriction.

METHODS: 266 patients with low back pain answered questions from a range of widely used questionnaires. An exploratory factor analysis (EFA) was used to identify disability dimensions which were then subjected to Rasch analysis. Reliability was tested by internal consistency and person separation index (PSI). Discriminant validity of disability levels were evaluated by Spearman correlation coefficient (r), intraclass correlation coefficient [ICC(2,1)] and the Bland-Altman approach. A CAT was developed for each dimension, and the results checked against simulated and real applications from a further 133 patients.

RESULTS: Factor analytic techniques identified two dimensions named "body functions" and "activity-participation". After deletion of some items for failure to fit the Rasch model, the remaining items were mostly free of Differential Item Functioning (DIF) for age and gender. Reliability exceeded 0.90 for both dimensions. The disability levels generated using all items and those obtained from the real CAT application were highly correlated (i.e. >0.97 for both dimensions). On average, 19 and 14 items were needed to estimate the precise disability levels using the initial CAT for the first and second dimension. However, a marginal increase in the standard error of the estimate across successive iterations substantially reduced the number of items required to make an estimate.

CONCLUSIONS: Using a combination approach of EFA and Rasch analysis this study has shown that it is possible to calibrate items onto a single metric in a way that can be used to provide the basis of a CAT application. Thus there is an opportunity to obtain a wide variety of information to evaluate the biopsychosocial model in its more complex forms, without necessarily increasing the burden of information collection for patients.

BACKGROUND: This study explored the feasibility of using an Internet survey of people with fibromyalgia (FM), with a view to providing information on demographics, sources of information, symptoms, functionality, perceived aggravating factors, perceived triggering events, health care utilization, management strategies, and medication use.

METHODS: A survey questionnaire was developed by the National Fibromyalgia Association (NFA) in conjunction with a task force of "experts in the field". The questionnaire underwent several rounds of testing to improve its face validity, content validity, clarity and readability before it was mounted on the internet. The questionnaire consisted of 121 items and is available online at the website of the National Fibromyalgia Association.

RESULTS: The questionnaire was completed by 2,569 people. Most were from the United States, with at least one respondent from each of the 50 states. Respondents were predominantly middle-aged Caucasian females, most of whom had FM symptoms for > or = 4 years. The most common problems were morning stiffness, fatigue, nonrestorative sleep, pain, concentration, and memory. Aggravating factors included: emotional distress, weather changes, insomnia, and strenuous activity. Respondents rated the most effective management modalities as rest, heat, pain medications, antidepressants, and hypnotics. The most commonly used medications were: acetaminophen, ibuprofen, naproxen, cyclobenzaprine, amitriptyline, and aspirin. The medications perceived to be the most effective were: hydrocodone preparations, aprazolam, oxycodone preparations, zolpidem, cyclobenzaprine, and clonazepam.

CONCLUSION: This survey provides a snap-shot of FM at the end of 2005, as reported by a self-selected population of people. This descriptive data has a heuristic function, in that it identifies several issues for further research, such as the prescribing habits of FM health care providers, the role of emotional precipitants, the impact of obesity, the significance of low back pain and the nature of FM related stiffness.

BACKGROUND: Deviated wrist postures and pinch grip use have been linked to the development of carpal tunnel syndrome and are likely related to the size and shape of the carpal tunnel. The purpose of this study was to quantify carpal tunnel dimensions with changes in wrist posture and pinch grip.

METHODS: Eight healthy volunteers (4 male, 4 female) underwent magnetic resonance imaging of their dominant wrists under seven conditions which included: 30 degrees wrist extension, neutral and 30 degrees flexion (with and without a 10N pinch force) and a fist with a neutral wrist. Cross-sectional area of the carpal tunnel and its contents were calculated at 3mm increments along the length of the tunnel and integrated to calculate volumes. Ratios were calculated between the contents of the tunnel to the tunnel itself for area and volume. FINDINGS: The use of a correction factor significantly reduced volume and distal carpal tunnel area in flexed and extended wrists. Carpal tunnel areas were largest in neutral and smallest at the distal end with wrist flexion. An extended wrist resulted in the smallest carpal tunnel and content volumes as well as the smallest carpal tunnel content volume to carpal tunnel volume ratios. While men had significantly larger areas and volumes than women for both the carpal tunnel and it contents, there were no differences in ratios between the contents and tunnel size.

INTERPRETATION: A simple correction factor for non-perpendicular magnetic resonance images proved useful in relating volume changes to known pressure changes within the carpal tunnel. More inclusive and detailed evaluation of the carpal tunnel and its contents is required to fully understand mechanisms for median nerve compression in the carpal tunnel.

BACKGROUND: We determined prospectively the long-term outcomes of nonoperative treatment of chronic patellofemoral pain syndrome.

METHODS: Of forty-nine patients in a prospective, randomized, double-blind study of unilateral chronic patellofemoral pain syndrome in the knee, forty-five were reexamined seven years after the initial trial of treatment. In the earlier trial, the short-term (six-month) effects of intra-articular injections of glycosaminoglycan polysulfate combined with intensive quadriceps-muscle exercises were compared with those of injections of a placebo combined with exercises and with those of exercises alone. At seven years, the follow-up consisted of standardized subjective, functional, and clinical assessments and muscle-strength measurements as well as magnetic resonance imaging, radiography, and bone-densitometry measurements of the knee.

RESULTS: At six months, complete subjective, functional, and clinical recovery had occurred in almost three-fourths of the patients and, with the numbers available for study, neither significant nor clinically important differences among the three initial treatment groups were detected. The subjective and functional parameters showed few changes between six months and seven years; almost three-fourths of the patients still had full subjective and functional recovery at the time of the latest follow-up. However, according to the physician's clinical evaluation, the number of patients who had no symptoms on the patellar compression and apprehension tests decreased over time, from forty-two (93 percent) and forty (89 percent) of forty-five patients at six months to thirty (67 percent) and thirty-one (69 percent) at seven years; these changes were significant (p = 0.002 and p = 0.023, respectively). The number of patients who had crepitation on the patellar compression test increased over time, from twenty-six (58 percent) at six months to thirty-six (80 percent) at seven years (p = 0.021). The physician's overall assessment showed a similar trend, with thirty-four patients (76 percent) having had complete recovery at six months compared with thirty (67 percent) at seven years; however, with the numbers available, this change was not significant (p = 0.420). Magnetic resonance imaging, performed for thirty-seven patients, revealed no abnormalities in twenty-four (65 percent), mild abnormalities in four (11 percent), moderate abnormalities (a 25 to 75 percent decrease in the thickness of the cartilage) in seven (19 percent), and overt patellofemoral osteoarthritis in two (5 percent) at seven years.

CONCLUSIONS: The seven-year overall outcome was good in approximately two-thirds of the patients. However, the remaining patients still had symptoms or objective signs of a patellofemoral abnormality.

STUDY DESIGN: Cross-sectional.

OBJECTIVES: To investigate whether females seeking physical therapy treatment for unilateral patellofemoral pain syndrome (PFPS) exhibit deficiencies in hip strength compared to a control group.

BACKGROUND: Decreased hip strength may be associated with poor control of lower extremity motion during weight-bearing activities, leading to abnormal patellofemoral motions and pain. Previous studies exploring the presence of hip strength impairments in subjects with PFPS have reported conflicting results.

METHODS AND MEASURES: Twenty females, aged 12 to 35 years, participated in the study. Ten subjects with unilateral PFPS were compared to 10 control subjects with no known knee pathologies. Hip abduction, extension, and external rotation strength were tested using a handheld dynamometer. A limb symmetry index (LSI) was used to quantify physical performance for all tests.

RESULTS: The symptomatic limbs of subjects with PFPS exhibited impairments in hip strength for all variables tested. LSI values in subjects with PFPS (range, 71%-79%) were significantly lower than those in control subjects (range, 93%-101%) (P< or =.007). A secondary analysis of data normalized to body mass demonstrated that the symptomatic limbs of subjects with PFPS had 52% less hip extension strength (P<.001), 27% less hip abduction strength (P = .007), and 30% less hip external rotation strength (P= .004) when compared to the weaker limbs of control subjects.

CONCLUSION: Females aged 12 to 35 presenting with unilateral PFPS demonstrate significant impairments in hip strength compared to control subjects when LSI values or body mass normalized values are used to quantify physical performance of the symptomatic limb.

PURPOSE: To evaluate the prevalence and radiologic findings of annular tear (especially of contrast material enhancement), bulging disk, and disk herniation on T2-weighted and gadolinium-enhanced T1-weighted magnetic resonance (MR) images in people without low back pain (LBP) or sciatica.

MATERIALS AND METHODS: Thirty-six volunteers without LBP and/or sciatica (18 with no symptoms in their lifetime and 18 who were pain free for at least 6 months) were examined with sagittal and axial T2-weighted fast spin-echo (SE) and sagittal gadolinium-enhanced T1- weighted fast SE imaging. The prevalence and MR findings of bulging disk, focal protrusion, extrusion, and nonenhancing or enhancing annular tears were assessed.

RESULTS: The prevalence of bulging disk and focal disk protrusion was 81% (29 volunteers) and 33% (12 volunteers), respectively. There were no extrusions. Twenty-eight annular tears were found in 20 patients (56%); 27 tears (96%) also showed contrast enhancement.

CONCLUSION: Annular tears and focal disk protrusions on MR images, with or without contrast enhancement, are frequently found in an asymptomatic population. Extruded disk herniation, displacement of nerve root, and interruption of annuloligamentous complex are unusual findings in an asymptomatic population and can be more closely related to patients with LBP or sciatica.

BACKGROUND: Knee osteoarthritis (OA) is a progressive disease that initially affects the articular cartilage. Observational studies have shown benefits for arthroscopic debridement (AD) on the osteoarthritic knee, but other recent studies have yielded conflicting results that suggest AD may not be effective.

OBJECTIVES: To identify the effectiveness of AD in knee OA on pain and function. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006); MEDLINE (1966 to August, 2006); CINAHL (1982 to 2006); EMBASE (1988 to 2006) and Web of Science (1900 to 2006) and screened the bibliographies, reference lists and cited web sites of papers. SELECTION CRITERIA: We included randomised controlled trials (RCT) or controlled clinical trials (CCT) assessing effectiveness of AD compared to another surgical procedure, including sham or placebo surgery and other non-surgical interventions, in patients with a diagnosis of primary or secondary OA of the knees, who did not have other joint involvement or conditions requiring long term use of non-steroidal anti-inflammatory drugs (NSAIDs). The main outcomes were pain relief and improved function of the knee. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed trial quality and extracted the data. Results are presented using weighted mean difference (WMD) for continuous data and relative risk (RR) for dichotomous data, and the number needed to treat to benefit (NNTB) or harm (NNTH).

MAIN RESULTS: Three RCTs were included with a total of 271 patients. They had different comparison groups and a moderate risk of bias. One study compared AD with lavage and with sham surgery. Compared to lavage the study found no significant difference. Compared to sham surgery placebo, the study found worse outcomes for AD at two weeks (WMD for pain 8.7, 95% CI 1.7 to 15.8, and function 7.7, 95% CI 1.1 to 14.3; NNTH=5) and no significant difference at two years. The second trial, at higher risk of bias, compared AD and arthroscopic washout, and found that AD significantly reduced knee pain compared to washout at five years (RR 5.5, 95% CI 1.7 to 15.5; NNTB=3). The third trial, also at higher risk of bias, compared AD to closed-needle lavage, and found no significant difference.

AUTHORS' CONCLUSIONS: There is 'gold' level evidence that AD has no benefit for undiscriminated OA (mechanical or inflammatory causes).

BACKGROUND: Various approaches have been proposed to treat articular cartilage lesions, which are plagued by inherent limited healing potential.

PURPOSE: To compare the clinical outcome of patients treated with second-generation autologous chondrocyte implantation implants with those treated with the microfracture repair technique at 5-year follow-up.

STUDY DESIGN: Cohort study; Level of evidence, 2.

METHODS: Eighty active patients (mean age, 29.8 years) and grade III to IV cartilage lesions of the femoral condyles or trochlea were treated with arthroscopic second-generation autologous chondrocyte implantation Hyalograft C or microfracture (40 patients per group). Patients achieved a minimum 5-year follow-up and were prospectively evaluated.

RESULTS: Both groups showed statistically significant improvement of all clinical scores from preoperative interval to 5-year follow-up. There was a significant improvement for the International Knee Documentation Committee subjective score from pre-operative to 5-year follow-up (Wilcoxon test, P < .001). In the microfracture group, the International Knee Documentation Committee objective score increased from 2.5% normal and nearly normal knees before the operation to 75% normal and nearly normal knees at 5-year follow-up, and the subjective score increased from 41.1 +/- 12.3 preoperatively to 70.2 +/- 14.7 at 5-year follow-up. In the group treated with Hyalograft C, the International Knee Documentation Committee objective score increased from 15% normal and nearly normal knees before the operation to 90% normal and nearly normal knees at 5-year follow-up, and its subjective score increased from 40.5 +/- 15.2 preoperatively to 80.2 +/- 19.1 at 5-year follow-up (Wilcoxon test, P < .001). When comparing the groups, better improvement of the International Knee Documentation Committee objective (P < .001) and subjective (P = .003) scores was observed in the Hyalograft C group at 5-year follow-up. The return to sports at 2 years was similar in both groups and remained stable after 5 years in the Hyalograft C group; it worsened in the microfracture group.

CONCLUSION: Both methods have shown satisfactory clinical outcome at medium-term follow-up. Better clinical results and sport activity resumption were noted in the group treated with second-generation autologous chondrocyte transplantation.

BACKGROUND: Epidemiological studies have reported an association between self-reported short sleep duration and high blood pressure (BP). Our objective was to examine both cross-sectional and longitudinal associations between objectively measured sleep and BP.

METHODS: This study is ancillary to the Coronary Artery Risk Development in Young Adults (CARDIA) cohort study. Blood pressure was measured in 2000 and 2001 and in 2005 and 2006. Sleep was measured twice using wrist actigraphy for 3 consecutive days between 2003 and 2005. Sleep duration and sleep maintenance (a component of sleep quality) were calculated. Analyses included 578 African Americans and whites aged 33 to 45 years at baseline. Outcome measures were systolic BP (SBP) and diastolic BP (DBP) levels, 5-year change in BP, and incident hypertension.

RESULTS: After we excluded the patients who were taking antihypertensive medications and adjusted for age, race, and sex, shorter sleep duration and lower sleep maintenance predicted significantly higher SBP and DBP levels cross-sectionally as well as more adverse changes in SBP and DBP levels over 5 years (all P < .05). Short sleep duration also predicted significantly increased odds of incident hypertension (odds ratio, 1.37; 95% confidence interval, 1.05-1.78). Adjustment for 16 additional covariates, including snoring and daytime sleepiness, slightly attenuated the associations between sleep and BP. Sleep duration appeared to mediate the difference between African Americans and whites in DBP change over time (P = .02).

CONCLUSION: Reduced sleep duration and consolidation predicted higher BP levels and adverse changes in BP, suggesting the need for studies to investigate whether interventions to optimize sleep may reduce BP.

PURPOSE: Does physical deconditioning (loss of cardiovascular capacity and strength/endurance of paraspinal muscles) exist in patients with chronic low back pain (CLBP) and are treatments specifically aimed to reduce these signs effective?

METHOD: Systematic literature search in PUBMED, MEDLINE, EMBASE and PsycINFO until December 2004 to identify observational studies regarding deconditioning signs and high quality RCTs regarding the effectiveness of cardiovascular and/or muscle strengthening exercises. Internal validity of the RCTs was assessed by using a checklist of nine methodology criteria in accordance with the Cochrane Collaboration.

RESULTS: There is conflicting evidence that cardiovascular deconditioning is present in CLBP and limited evidence for wasting of the multifidus muscle. No study examined the effectiveness of cardiovascular training specifically. General and lumbar muscle strengthening are equally effective as other active treatments. Only moderate evidence is available for the effectiveness of intensive low back extensor muscle strengthening compared to less intensive strengthening.

CONCLUSION: Probably reactivation caused by active treatment and not the reconditioning itself is the important factor in the reduction of disability. Further prospective and evaluative research into the role of physical deconditioning is necessary. It seems more promising to further explore the interplay between biological, social and psychological factors.

BACKGROUND CONTEXT: Neck pain is common, disabling, and costly. The effectiveness of patient education strategies is unclear.

PURPOSE: To assess whether patient education strategies are of benefit for pain, function/disability, global perceived effect, quality of life, or patient satisfaction, in adults with neck pain with or without radiculopathy.

STUDY DESIGN: Cochrane systematic review.

METHODS: Computerized bibliographic databases were searched from their start to May 31, 2008. Eligible studies were randomized trials investigating the effectiveness of patient education strategies for neck pain. Paired independent reviewers carried out study selection, data abstraction, and methodological quality assessment. Relative risk and standardized mean differences were calculated. Because of differences in intervention type or disorder, no studies were considered appropriate to pool.

RESULTS: Of the 10 selected trials, two (20%) were rated as of high quality. Patient education was assessed as follows: 1) eight trials of advice focusing on activation compared with no treatment, or to various active treatments, including therapeutic exercise, manual therapy, and cognitive behavioral therapy, showed either inferiority or no difference for pain, spanning a full range of follow-up periods, acuity and disorder types. When compared with rest, two trials that assessed acute whiplash-associated disorder showed moderate evidence of no difference for advice focusing on activation; 2) two trials studying advice focusing on pain and stress coping skills found moderate evidence of no benefit for chronic neck pain at intermediate- to long-term follow-up; and 3) one trial compared the effects of neck school to no treatment, yielding limited evidence of no benefit for pain, at intermediate-term follow-up in mixed acute/subacute/chronic neck pain.

CONCLUSIONS: This review has not shown effectiveness for educational interventions for neck pain of various acuity stages and disorder types and at various follow-up periods, including advice to activate, advice on stress coping skills, and neck school. In future research, further attention to methodological quality is necessary. Studies of multimodal interventions should consider study designs, such as factorial designs, that permit discrimination of specific educational components.

OBJECTIVE: To determine the effectiveness (at the 0.1 level of statistical significance) of the Align-Right (roll-shaped) cervical pillow (ARCP) on neck pain severity and headache/neck pain medication use in chronic neck pain subjects.

DESIGN: The design was a "before/after" (i.e., a "pre/post" trial).

SUBJECTS: Twenty-eight subjects, 25-45 yr of age with cervical spine pain of biomechanical origin of > 2 on an 11-point ordinal pain scale.

OUTCOME MEASURES: The primary outcome measure was severity of morning and evening neck pain. The secondary outcome measure was daily quantity of analgesics ingested. The data were analyzed descriptively and inferentially for clinically and statistically significant pre/post intervention differences.

METHODS: Eligible subjects who successfully finished a 2-wk baseline data-gathering period by mailing in two properly completed diaries each received a pillow and four more diaries (to be filled in over the subsequent 4 wk). Three repeated-measures analyses of variance were performed using the Bonferroni-corrected level of statistical significance of 0.03. Ninety-five percent confidence intervals (for paired-samples mean differences) were also calculated for those pre/post differences that seemed descriptively clinically important.

RESULTS: The clinically and statistically significant reductions in neck/shoulder pain severity in this sample of chronic neck pain subjects suggest that the ARCP is an effective therapy for target populations with the same profile as this sample. Patient characteristics predicting suitability were not studied in this project.

CONCLUSION: The results suggest that the ARCP has clinically important beneficial effects on the neck pain severity of most chronic neck-pain sufferers. Further randomized clinical trial research comparing the ARCP with other commonly used cervical pillows is recommended.

OBJECTIVES: To investigate the biochemical milieu of the upper trapezius muscle in subjects with active, latent, or absent myofascial trigger points (MTPs) and to contrast this with that of the noninvolved gastrocnemius muscle.

DESIGN: We used a microanalytic technique, including needle insertions at standardized locations in subjects identified as active (having neck pain and MTP), latent (no neck pain but with MTP), or normal (no neck pain, no MTP). We followed a predetermined sampling schedule; first in the trapezius muscle and then in normal gastrocnemius muscle, to measure pH, bradykinin, substance P, calcitonin gene-related peptide, tumor necrosis factor alpha, interleukin 1beta (IL-1beta), IL-6, IL-8, serotonin, and norepinephrine, using immunocapillary electrophoresis and capillary electrochromatography. Pressure algometry was obtained. We compared analyte concentrations among groups with 2-way repeated-measures analysis of variance.

SETTING: A biomedical research facility.

PARTICIPANTS: Nine healthy volunteer subjects.

INTERVENTIONS: Not applicable.

MAIN OUTCOME MEASURES: Preselected analyte concentrations.

RESULTS: Within the trapezius muscle, concentrations for all analytes were higher in active subjects than in latent or normal subjects (P<.002); pH was lower (P<.03). At needle insertion, analyte concentrations in the trapezius for the active group were always higher (pH not different) than concentrations in the gastrocnemius muscle. At all times within the gastrocnemius, the active group had higher concentrations of all analytes than did subjects in the latent and normal groups (P<.05); pH was lower (P<.01).

CONCLUSIONS: We have shown the feasibility of continuous, in vivo recovery of small molecules from soft tissue without harmful effects. Subjects with active MTPs in the trapezius muscle have a biochemical milieu of selected inflammatory mediators, neuropeptides, cytokines, and catecholamines different from subjects with latent or absent MTPs in their trapezius. These concentrations also differ quantitatively from a remote, uninvolved site in the gastrocnemius muscle. The milieu of the gastrocnemius in subjects with active MTPs in the trapezius differs from subjects without active MTPs.

CONTEXT: Biomechanically, hip muscle strength and flexibility are necessary to control and facilitate proper distal limb motion while running. Only one study has investigated the effectiveness of rehabilitation of running injuries via hip muscle strengthening and only involved iliotibial band syndrome.

OBJECTIVE: To determine if increases in hip muscle strength and flexibility are associated with a significant reduction in pain associated with running injuries. It was hypothesized that patients would demonstrate a significant improvement in hip muscle strength and flexibility and a minimum 50% reduction in pain following a 4-6 week rehabilitation program.

DESIGN: Pre-test/post-test.

SETTING: Patients presenting to the Running Injury Clinic.

PATIENTS OR OTHER PARTICIPANTS: 284 consecutive patients presenting to the Clinic for various musculoskeletal running injuries (females: 183; males: 101; age: 37 years±8.3; weekly running mileage 35.7 km±9.4).

INTERVENTIONS: Patients were asked to report the average amount of pain they were experiencing while running using a 10cm visual analog scale (VAS). Hip internal and external rotator muscle flexibility was measured using a goniometer. The Thomas and Ober clinical tests were used to determine hip flexor and IT band flexibility. Hip muscle strength was measured using a standard 0-5 manual muscle scale. For statistical analysis, strength values were converted from a 0-5 scale to a percentage score assuming 5/5 equalled 100% and 3/5 equalled 50% of maximum isometric force. Minimum standards for each strength and flexibility measure were established through pilot work and literature. A rehabilitation program was prescribed to improve hip strength and/or flexibility where necessary. Paired t-tests (alpha=0.05) were used for statistical comparisons.

MAIN OUTCOME MEASURES: Pre-post comparisons of VAS and hip strength and flexibility measures following 4-6 weeks of rehabilitation.

RESULTS: Patellofemoral pain syndrome (n=54), iliotibial band syndrome (n=40), medial tibial stress syndrome (n=13), Achilles tendinopathy (n=10), and plantar fasciitis (n=10) accounted for the majority of injuries. 165 patients (58%) returned for follow-up assessment and reported a significant improvement in pain (VAS pre: 6.11cm±0.87 post: 0.89cm±1.22; P=0.01) and 89% reported at least a 50% improvement in pain. These patients also exhibited significant improvements in hip abductor (pre: 78.55%±11.07 post: 95.32%±7.81; P=0.02), flexor (pre: 77.11%±13.92 post: 91.94%±6.78; P=0.03), and external rotator (pre: 76.06%±14.94 post: 90.48%±10.70; P=0.03) muscle strength. Significant increases in hip internal rotator (pre: 39.67 deg±6.29 post 45.39 deg ±4.99; P=0.01) and external rotator (pre: 36.71 deg ±4.26 post: 44.16 deg ±3.74 deg; P=0.01) muscle flexibility was measured. 86% of patients who exhibited a positive Thomas or Ober’s test prior to the rehabilitation program exhibited no tissue inflexibility at follow-up.

CONCLUSIONS: The results from this study suggest that a hip strength and flexibility rehabilitation program, based on the biomechanics of running and specific clinical criteria, can effectively resolve pain associated with various musculoskeletal running injuries.

OBJECTIVE: To study the efficacy and tolerability of amitriptyline and nortriptyline in a Brazilian population with fibromyalgia and to evaluate the instruments used to measure the efficacy of the treatment.

METHODS: A total of 118 fibromyalgia patients were randomly assigned to 3 groups: amitriptyline (AM, n = 40), nortriptyline (NOR, n =38) and placebo (PL, n = 40), and were blindly given 25 mg at bedtime of the assigned treatment for 8 weeks. Clinical evaluation before and at the end of the study included the number of tender points (NTP), FIQ score (FIQ), and global improvement as reported by the patients on a verbal scale (VSGI).

RESULTS: The 3 groups were comparable at baseline for all the parameters studied. After 8 weeks, the 3 groups improved in all parameters: (36.5% AM, 26.7% NOR and 24% PL patients improved on FIQ; 13.9% AM, 19.5% NOR and 8.57% PL patients improved on NTP; 86.5% AM, 72.2% NOR and 57.6% PL patients improved on VSGI). Only the AM group differed from the PL group on VSGI. Side effects were noted among the groups, but none were serious (16 in the AM group, 31 in the NOR group, and 25 in the PL group).

CONCLUSION: All three groups improved after treatment. Only the patient's subjective global assessment of improvement differed between the AM patients and the PL group (p < or = 0.03). In fibromyalgia, placebo groups are important in drug trials. Different measures of therapeutic effect are not better than the patient's self assessment.

BACKGROUND: Botulinum toxin type A (BTA) (Botox) received Food and Drug Administration (FDA) approval for therapeutic treatment of strabismus and blepharospasm in 1989, cervical dystonia in 2000, and cosmetic treatment of glabellar wrinkles (Botox Cosmetic) in 2002. In 2002 alone there were approximately 1.1 to 1.6 million patients using cosmetic BTA. Our objective was to review adverse event (AE) reporting to the FDA after BTA administration.

METHODS: We reviewed all (therapeutic and cosmetic use) serious (per FDA regulations) AEs reported to the FDA for the 13.5 years since licensure of the product (December 1989-May 2003) and nonserious AEs reported from December 2001 to November 2002. AEs are reported to the FDA through the MedWatch system.

RESULTS: We reviewed 1437 AE reports; 406 followed therapeutic use of BTA (217 serious and 189 nonserious) and 1031 followed cosmetic use (36 serious and 995 nonserious). Reported AEs occurred predominantly in female patients, with a median age of 50 years. In the year December 2001 to November 2002, when both serious and nonserious reports were evaluated, the proportion of reports classified as serious was 33-fold higher for therapeutic than for cosmetic cases. The 217 serious AEs reported in therapeutic cases involved a wide spectrum of events and included all 28 reported deaths. Among cosmetic users, no deaths were reported and, of the 36 serious AEs, 30 were included as possible complications in the FDA-approved label. The remaining 6 serious AEs did not display a pattern suggesting a common causal relationship to BTA. Among the 995 cosmetic cases reported to have nonserious AEs, most commonly noted were lack of effect (623, 63%), injection site reaction (190, 19%), and ptosis (111, 11%).

CONCLUSIONS: Serious AEs were more likely to be reported for therapeutic than for cosmetic use, which may be related to higher doses, complicated underlying diseases, or both. Among cosmetic cases, few serious AEs were reported, and these were predominantly events that were previously recognized in clinical trials of BTA for the labeled use. This study is limited primarily by the incomplete nature of AE reporting by clinicians. Numerous departures from FDA-approved recommendations for drug dose, dilution, handling, site of injection, and storage were noted in these AE reports.

METHODS: A prospective evaluation of 123 patients with calcaneal spurs in 136 heels and plantar heel pad pain in association with diabetes mellitus, body mass index >27, elevated uric acid and heel pad compressibility index, were matched with a control group of 141 patients (136 heels) without heel pad pain or co-morbid factors. This study was carried out between February 1997 and September 1999 in three hospitals. There were 91 females and 32 males in the study group, while the control group had 86 females and 55 males.

RESULTS: All patients in the study cohort presented with calcaneal spurs and plantar heel pad pain. The mean age for the males was 38.1 ± 2.4 and females 43.3 ± 0.8. 78.04% (96 patients) had body mass index (BMI) of over 27, in 48 patients (39.02%) uric acid levels were elevated above two standard deviations from the mean and 59 patients (47.96%) were diabetic, some with more than a single factor. The heel pad compressibility index of 0.54 ± 1.06 in males and 0.62 ± 0.02 in females of the study population was significantly greater than in the control population (males: 0.49 ± 0.4, females: 0.56 ± 1.8). The study and control groups were comparable with respect to age.

CONCLUSION: Calcaneal spurs cause plantar heel pad pain, but the roles of other co-morbid factors are significant. The excision of these spurs does not necessarily abolish pain. It is evident that heel pad compressibility increases with advancing age, weight gain, and diabetes mellitus, and contributes to the pathogenesis of plantar heel pain. This has an impact on the management of these patients, by de-emphasizing the role of surgical excision of these spurs.

BACKGROUND: Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems. One review concludes that the former is clinically effective in relation to prevention, whereas the latter has been tested in only 1 randomized clinical trial, concluding that stress fractures could be prevented.

OBJECTIVES: To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible.

DESIGN: Prospective, randomized, controlled intervention trial. STUDY

SUBJECTS: One female and 145 male military conscripts (aged 18 to 24 years), representing 25% of all new conscripts in a Danish regiment.

METHOD: Health data were collected by questionnaires at initiation of the study and 3 months later. Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period. No intervention was provided for the control group. Differences between the 2 groups were tested with the chi-square test, and statistical significance was accepted at P <.05. Risk ratio (RR), risk difference (ARR), numbers needed to prevent (NNP), and cost per successfully prevented case were calculated.

OUTCOME VARIABLES: Outcome variables included self-reported back and/or lower extremity problems; specific problems in the back or knees or shin splints, Achilles tendonitis, sprained ankle, or other problems in the lower extremity; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems.

RESULTS: Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems (RR 0.7, ARR 19%, NNP 5, cost 98 US dollars); number of subjects with shin splints (RR 0.2, ARR 19%, NNP 5, cost 101 US dollars); number of off-duty days because of back or lower extremity problems (RR 0.6, ARR < 1%, NNP 200, cost 3750 US dollars). In an intention-to-treat analysis, a significant difference was found for only number of subjects with shin splints (RR 0.3, ARR 18%, NNP 6 cost 105 US dollars), whereas a worst-case analysis revealed no significant differences between the study groups.

CONCLUSIONS: This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses. However, because care-seeking for lower extremity problems is rare, using this method of prevention in military conscripts would be too costly. We also noted that the choice of statistical approach determined the outcome.

OBJECTIVE: To determine the frequency, severity, prognosis, and patterns of carpal tunnel syndrome (CTS) in pregnancy.

DESIGN: Descriptive retrospective chart review using the Rochester Epidemiology Project medical record diagnostic indexing system to identify patients with new CTS occurring during pregnancy from 1987 to 1992 at our institution.

SETTING: Obstetrical practice, where two thirds of pregnant women in the county receive primary obstetrical care.

PATIENTS: Women pregnant during 1987 to 1992 who had a new diagnosis of CTS. Women with pregnancies at other dates or women who had CTS with onset before or after pregnancy were excluded.

OUTCOME MEASURES: Age, underlying medical problems, gestation interval, weight gain, number of pregnancies, presenting symptoms, onset and duration of symptoms before diagnosis, trimester of CTS diagnosis, treatment and response, and results of electrophysiologic studies are described.

RESULTS: Of 10,873 pregnant patients receiving antenatal care for 14,579 pregnancies, 50 (.34%) fulfilled the inclusion criteria. Their mean age was 30.5 +/- 4.0 yrs. Twelve patients (24%) were primigravid. Mean weight gain was 12.1 +/- 5.7 kg. CTS was diagnosed most frequently during the third trimester (n = 25, 50%). Symptom onset, when recorded, occurred with even distribution during each trimester: first, n = 11 (32%); second, n = 11 (32%); third, n = 12 (35%). For 37 patients in whom symptom duration was recorded, duration before diagnosis was 9.3 +/- 9.0 weeks. Paresthesia (88%) was most often bilateral (68%), and 67% of patients had pain. The Tinel sign was present over the median nerve at the wrist in 95%. Only nine patients had nerve conduction studies performed. During pregnancy, 37 women were treated nonsurgically with wrist orthoses, steroid injections, or both. Of treated patients for whom follow-up data were available, 25 of 26 improved, and 4 of 26 required surgery. Thirteen women had no treatment during pregnancy; three underwent surgery in the postpartum period. All 7 women in whom conservative treatment failed who underwent surgery had resolution of symptoms.

CONCLUSION: These results represent the frequency and patterns of clinically significant CTS in a large population of pregnant women. CTS severe enough to warrant treatment occurs infrequently in pregnancy and generally resolves spontaneously postpartum or responds to conservative treatment.

STUDY DESIGN: A double-blind, randomized, controlled trial.

OBJECTIVE: To determine the clinical effectiveness of therapeutic local anesthetic cervical medial branch blocks with or without steroid in managing chronic neck pain of facet joint origin.

SUMMARY OF BACKGROUND DATA: The prevalence of persistent neck pain, secondary to involvement of cervical facet or zygapophysial joints, has been described in controlled studies as varying from 39% to 67%. Intra-articular injections, medial branch nerve blocks, and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin.

METHODS: A total of 120 patients were included, with 60 patients in each of the local anesthetic and steroid groups. All the patients met the diagnostic criteria of cervical facet joint pain by means of comparative, controlled diagnostic blocks, and the inclusion criteria. Group I consisted of medial branch blocks with bupivacaine. Group II consisted of cervical medial branch blocks with bupivacaine and steroid. Numerical pain scores, Neck Disability Index, opioid intake, and work status were evaluated at baseline, 3 months, 6 months, and 12 months.

RESULTS: Significant pain relief (>or=50%) and functional status improvement was observed at 3 months, 6 months, and 12 months in over 83% of patients. The average number of treatments for 1 year was 3.5 +/- 1.0 in the nonsteroid group and 3.4 +/- 0.9 in the steroid group. Duration of average pain relief with each procedure was 14 +/- 6.9 weeks in the nonsteroid group, and it was 16 +/- 7.9 weeks in the steroid group. Significant relief and functional improvement was reported for 46 to 48 weeks in a year.

CONCLUSION: Therapeutic cervical medial branch nerve blocks, with or without steroids, may provide effective management for chronic neck pain of facet joint origin.

STUDY DESIGN: A double-blind, randomized, controlled trial.

OBJECTIVE: To determine the clinical effectiveness of therapeutic local anesthetic cervical medial branch blocks with or without steroid in managing chronic neck pain of facet joint origin.

SUMMARY OF BACKGROUND DATA: The prevalence of persistent neck pain, secondary to involvement of cervical facet or zygapophysial joints, has been described in controlled studies as varying from 39% to 67%. Intra-articular injections, medial branch nerve blocks, and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin.

METHODS: A total of 120 patients were included, with 60 patients in each of the local anesthetic and steroid groups. All the patients met the diagnostic criteria of cervical facet joint pain by means of comparative, controlled diagnostic blocks, and the inclusion criteria. Group I consisted of medial branch blocks with bupivacaine. Group II consisted of cervical medial branch blocks with bupivacaine and steroid. Numerical pain scores, Neck Disability Index, opioid intake, and work status were evaluated at baseline, 3 months, 6 months, and 12 months.

RESULTS: Significant pain relief (>or=50%) and functional status improvement was observed at 3 months, 6 months, and 12 months in over 83% of patients. The average number of treatments for 1 year was 3.5 +/- 1.0 in the nonsteroid group and 3.4 +/- 0.9 in the steroid group. Duration of average pain relief with each procedure was 14 +/- 6.9 weeks in the nonsteroid group, and it was 16 +/- 7.9 weeks in the steroid group. Significant relief and functional improvement was reported for 46 to 48 weeks in a year.

CONCLUSION: Therapeutic cervical medial branch nerve blocks, with or without steroids, may provide effective management for chronic neck pain of facet joint origin.

STUDY DESIGN AND OBJECTIVES: Our systematic review of randomized trials assessed whether manipulation and mobilization relieve pain or improve function/disability, patient satisfaction, and global perceived effect in adults with mechanical neck disorders.

SUMMARY OF BACKGROUND DATA: Neck disorders are common, disabling, and costly.

METHODS: Computerized bibliographic databases were searched up to March 2002. Two independent reviewers conducted study selection, data abstraction, and methodologic quality assessment. Relative risk and standardized mean differences were calculated. In the absence of heterogeneity, pooled effect measures were calculated using a random effects model.

RESULTS: Of the 33 selected trials, 42% were high quality trials. Single or multiple (3-11) sessions of manipulation or mobilization showed no benefit in pain relief when assessed against placebo, control groups, or other treatments for acute/subacute/chronic mechanical neck disorders with or without headache. There was strong evidence of benefit favoring multimodal care (mobilization and/or manipulation plus exercise) over a waiting list control for pain reduction [pooled standardized mean differences -0.85 (95% CI: -1.20 to -0.50)], improvement in function [pooled SMD -0.57 (95% CI: -0.94 to -0.21)] and global perceived effect [standardized mean differences -2.73 (95% CI: -3.30 to -2.16)] for subacute/chronic mechanical neck disorders with or without headache.

CONCLUSIONS: Mobilization and/or manipulation when used with exercise are beneficial for persistent mechanical neck disorders with or without headache. Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior. There was insufficient evidence available to draw conclusions for neck disorder with radicular findings. Factorial design would help determine the active agent(s) within a treatment mix.

OBJECTIVE: To assess the effectiveness of intra-articular triamcinolone injection and physiotherapy singly or combined in the treatment of adhesive capsulitis of the shoulder.

METHODS: Eighty patients with adhesive capsulitis of less than 6 months duration were randomized to one of four groups: Group A, injection of triamcinolone 20 mg and eight sessions of standardized physiotherapy; Group B, injection of triamcinolone 20 mg alone; Group C, placebo injection and eight sessions of standardized physiotherapy; or Group D, placebo injection alone. All subjects were given an identical home exercise programme. Outcome measures were assessed at 6 weeks and 16 weeks. The primary outcome measure was Shoulder Disability Questionnaire (SDQ) score. Secondary outcomes were measurement of pain using a visual analogue scale (VAS), global disability using VAS and range of passive external rotation. A two-way analysis of variance was used to explore the effects of corticosteroid injection and physiotherapy.

RESULTS: At 6 weeks, the SDQ had improved significantly more in the groups receiving corticosteroid injection (P = 0.004). Physiotherapy improved passive external rotation at 6 weeks (P = 0.02) and corticosteroid injection improved self-assessment of global disability at 6 weeks (P = 0.04). There was no interaction effect between injection and physiotherapy. At 16 weeks, all groups had improved to a similar degree with respect to all outcome measures.

CONCLUSION: Corticosteroid injection is effective in improving shoulder-related disability, and physiotherapy is effective in improving the range of movement in external rotation 6 weeks after treatment.

OBJECTIVE: To compare three pillows with regard to pain intensity, pain relief, quality of sleep, disability, and overall satisfaction in subjects with benign cervical pain. The three pillows evaluated were the subjects' usual pillow, a roll pillow, and a water-based pillow.

STUDY DESIGN: Subjects used their usual pillows for the first week of this 5-week randomized crossover design study. They were subsequently randomly assigned to use each of the other two pillows for 2-week periods.

SETTING: Outpatient neurology and physiatry clinics.

PATIENTS: Forty-one subjects with benign cervical pain syndromes and free of cognitive impairments.

MAIN OUTCOME MEASURES: Visual analog scale (VAS), Sleep Questionnaire, Sickness Impact Profile (SIP), and a satisfaction scale rating the pillows.

RESULTS: The water-based pillow was associated with reduced morning pain intensity, increased pain relief, and improved quality of sleep. The duration of sleep was significantly shorter for the roll pillow. Overall SIP findings showed a significant advantage for the water-based pillow over the roll pillow and standard pillow.

CONCLUSIONS: Proper selection of a pillow can significantly reduce pain and improve quality of sleep but does not significantly affect disability outcomes measured by the SIP.

STUDY DESIGN: An intraoperative straight-leg-raising (SLR) test was conducted to investigate patients with lumbar disc herniation to observe the changes in intraradicular blood flow, which then were compared with the clinical features.

OBJECTIVE: The legs of each patient were hung down from the operating table as a reverse SLR test during surgery, and intraradicular blood flow was measured.

SUMMARY OF BACKGROUND DATA: It is not known whether intraradicular blood flow changes during the SLR test in patients with lumbar disc herniation.

METHODS: The subjects were 12 patients with lumbar disc herniation who underwent microdiscectomy. The patients were asked to adopt the prone position immediately before surgery, so that their legs hung down from the operating table. A reverse SLR test was performed to confirm the angle at which sciatica developed. During the operation, the nerve roots affected by the hernia were observed under a microscope. Then the needle sensor of a laser Doppler flow meter was inserted into each nerve root immediately above the hernia. The patient's legs were allowed to hang down to the angle at which sciatica had occurred, and the change in intraradicular blood flow was measured. After removal of the hernia, a similar procedure was repeated, and intraradicular blood flow was measured again.

RESULTS: Intraoperative microscopy showed that the hernia was adherent to the dura mater of the nerve roots in all patients. The intraoperative reverse SLR test showed that the hernia compressed the nerve roots, and that there was marked disturbance of gliding, which was reduced to only a few millimeters. During the test, intraradicular blood flow showed a sharp decrease at the angle that produced sciatica, which lasted for 1 minute. Intraradicular flow decreased by 40% to 98% (average, 70.6% +/- 20.5%) in the L5 nerve root, and by 41% to 96% (average, 72.0% +/- 22.9%) in the S1 nerve roots relative to the blood flow before the test. At 1 minute after completion of the test, intraradicular blood flow returned to the value obtained at baseline. After removal of the hernia, all thepatients showed smooth gliding of the nerve roots during the second intraoperative test, and there was no marked decrease in intraradicular blood flow.

CONCLUSIONS: This study demonstrated that the blood flow in the nerve root is reduced when the nerve root is compressed in vivo.

PURPOSE: For many years, ultrasound (US) has been a widely used and well-accepted physical therapy modality for the management of musculoskeletal conditions. However, there is a lack of scientific evidence on its effectiveness. This study examined the opinions of physical therapists with advanced competency in orthopedics about the use and perceived clinical importance of US in managing commonly encountered orthopedic impairments.

SUBJECTS: Four hundred fifty-seven physical therapists who were orthopaedic certified specialists from the Northeast/Mid-Atlantic regions of the United States were invited to participate.

METHODS: A 77-item survey instrument was developed. After face and content validity were established, the survey instrument was mailed to all subjects. Two hundred seven usable survey questionnaires were returned (response rate=45.3%).

RESULTS: According to the surveys, the respondents indicated that they were likely to use US to decrease soft tissue inflammation (eg, tendinitis, bursitis) (83.6% of the respondents), increase tissue extensibility (70.9%), enhance scar tissue remodeling (68.8%), increase soft tissue healing (52.5%), decrease pain (49.3%), and decrease soft tissue swelling (eg, edema, joint effusion) (35.1%). The respondents used US to deliver medication (phonophoresis) for soft tissue inflammation (54.1%), pain management (22.2%), and soft tissue swelling (19.8%). The study provides summary data of the most frequently chosen machine parameters for duty cycle, intensity, and frequency.

CONCLUSION: Ultrasound continues to be a popular adjunctive modality in orthopedic physical therapy. These findings may help researchers prioritize needs for future research on the clinical effectiveness of US.

OBJECTIVE: To study prospectively the relations of insomnia to the development of anxiety disorders and depression in a population-based sample.

DESIGN: Cohort study based on data from 2 general health surveys of the adult population.

SETTING: Two general health surveys in the adult population in Nord-Trondelag County of Norway, HUNT-1 performed in 1984-6 and HUNT-2 in 1995-7

PARTICIPANTS: Participants without significant anxiety and depression in HUNT-1 were categorized according to the presence and absence of insomnia in the 2 surveys (N=25,130). MEASUREMENTS AND

RESULTS: Anxiety disorders and depression in HUNT-2 were assessed by the Hospital Anxiety and Depression Scale and analyzed using multivariate logistic regression analysis adjusted for age, gender, education, comorbid depression/anxiety, and history of insomnia. Anxiety disorders in HUNT-2 were significantly associated with the group with insomnia in HUNT-1 only (OR 1.6; 95% CI, 1.1-2.3), the group with insomnia in HUNT-2 only (OR 3.4; 95% CI, 3.1-3.8), as well as with the group with insomnia in both surveys (OR 4.9; 95% CI, 3.8-6.4). Depression in HUNT-2 was significantly associated with the group with insomnia in HUNT-2 only (OR 1.8; 95% CI, 1.6-2.0), but not with the groups with insomnia in HUNT-1 only or with insomnia in both surveys.

CONCLUSIONS: Only a state-like association between insomnia and depression was found. In addition to being a state marker, insomnia may be a trait marker for individuals at risk for developing anxiety disorders. Results are consistent with insomnia being a risk factor for the development of anxiety disorders.

OBJECTIVE: The aims of this double-blind, randomized, placebo-controlled trial were to determine whether ultrasound-guided extracorporeal shock wave therapy (ESWT) reduced pain and improved function in patients with lateral epicondylitis (tennis elbow) in the short term and intermediate term.

METHODS: Sixty-eight patients from community-based referring doctors were randomized to receive 3 ESWT treatments or 3 treatments at a subtherapeutic dose given at weekly intervals. Seven outcome measures relating to pain and function were collected at followup evaluations at 6 weeks, 3 months, and 6 months after completion of the treatment. The mean changes in outcome variables from baseline to 6 weeks, 3 months, and 6 months were compared for the 2 groups.

RESULTS: The groups did not differ on demographic or clinical characteristics at baseline and there were significant improvements in almost all outcome measures for both groups over the 6-month followup period, but there were no differences between the groups even after adjusting for duration of symptoms.

CONCLUSION: Our study found little evidence to support the use of ESWT for the treatment of lateral epicondylitis and is in keeping with recent systematic reviews of ESWT for lateral epicondylitis that have drawn similar conclusions.

OBJECTIVE: To describe the natural course of recent acute low back pain in terms of both morbidity (pain, disability) and absenteeism from work and to evaluate the prognostic factors for these outcomes.

DESIGN: Inception cohort study. Setting : Primary care.

PATIENTS: 103 patients with acute localised non-specific back pain lasting less than 72 hours.

MAIN OUTCOME MEASURES: Complete recovery (disappearance of both pain and disability) and return to work.

RESULTS: 90% of patients recovered within two weeks and only two developed chronic low back pain. Only 49 of 100 patients for whom data were available had bed rest and 40% of 75 employed patients lost no time from work. Proportional hazards regression analysis showed that previous chronic episodes of low back pain, initial disability level,initial pain worse when standing, initial pain worse when lying, and compensation status were significantly associated with delayed episode recovery.These factors were also related to abseteeism from work. Absenteeism from work was also influenced by job satisfaction and gender.

CONCLUSIONS: The recovery rate from acute low back pain was much higher than reported in other studies. Those studies, however, did not investigate groups of patients enrolled shortly after the onset of symptoms and often mixed acute low back pain patients with patients with exacerbations of chronic pain or sciatica. Several sociodemographic and clinical factors were of prognostic value in acute low back pain. Factors which incluenced the outcome in terms of episode recovery (mainly physical severity factors) were only partly predictive of absenteeism from work. Time off work and return to work depended more on sociodemographic and job related incluences.

PURPOSE: Therapeutic ultrasound is one of the most widely and frequently used electrophysical agents. Despite over 60 years of clinical use, the effectiveness of ultrasound for treating people with pain, musculoskeletal injuries, and soft tissue lesions remains questionable. This article presents a systematic review of randomized controlled trials (RCTs) in which ultrasound was used to treat people with those conditions. Each trial was designed to investigate the contributions of active and placebo ultrasound to the patient outcomes measured. Depending on the condition, ultrasound (active and placebo) was used alone or in conjunction with other interventions in a manner designed to identify its contribution and distinguish it from those of other interventions.

METHODS: Thirty-five English-language RCTs were published between 1975 and 1999. Each RCT identified was scrutinized for patient outcomes and methodological adequacy.

RESULTS: Ten of the 35 RCTs were judged to have acceptable methods using criteria based on those developed by Sackett et al. Of these RCTs, the results of 2 trials suggest that therapeutic ultrasound is more effective in treating some clinical problems (carpal tunnel syndrome and calcific tendinitis of the shoulder) than placebo ultrasound, and the results of 8 trials suggest that it is not.

CONCLUSION: There was little evidence that active therapeutic ultrasound is more effective than placebo ultrasound for treating people with pain or a range of musculoskeletal injuries or for promoting soft tissue healing. The few studies deemed to have adequate methods examined a wide range of patient problems. The dosages used in these studies varied considerably, often for no discernable reason.

OBJECTIVE: To determine whether treatment with spinal manipulative therapy (SMT) administered in addition to standard care is associated with clinically relevant early reductions in pain and analgesic consumption.

METHODS: We randomised 104 patients with acute low back pain to SMT in addition to standard care (n=52) or standard care alone (n=52). Standard care consisted of general advice and paracetamol, diclofenac or dihydrocodein as required. Other analgesic drugs or non-pharmacological treatments were not allowed. Primary outcomes were pain intensity assessed on the 11 point box scale (BS-11) and analgesic use based on diclofenac equivalence doses during days 1 to 14. An extended follow-up was performed at 6 months.

RESULTS: Pain reductions were similar in experimental and control groups, with the lower limit of the 95% confidence interval (95%-CI) excluding a relevant benefit of SMT (difference 0.5 on the BS-11, 95%-CI -0.2 to 1.2, p=0.13). Analgesic consumptions were also similar (difference -18 mg diclofenac equivalents, 95%-CI -43 mg to 7 mg, p=0.17), with small initial differences diminishing over time. There were no differences between groups in any of the secondary outcomes and stratified analyses provided no evidence for potential benefits of SMT in specific patient groups. The extended follow-up showed similar patterns.

CONCLUSIONS: SMT is unlikely to result in relevant early pain reduction in patients with acute low back pain.

OBJECTIVE: To compare the effectiveness of manual therapy and ultrasound (US) with manual therapy and placebo ultrasound (placebo US) in the treatment of new episodes of unilateral shoulder pain referred for physiotherapy.

METHODS: In a multicentre, double blind, placebo-controlled randomized trial, participants were recruited with a clinical diagnosis of unilateral shoulder pain from nine primary care physiotherapy departments in Birmingham, UK. Recruitment took place from January 1999 to September 2001. Participants were 18 yrs old and above. Participants all received advice and home exercises and were randomized to additionally receive manual therapy plus US or manual therapy plus placebo US. The primary outcome measure was the Shoulder Disability Questionnaire (SDQ-UK). Outcomes were assessed at baseline, 2 weeks, 6 weeks and 6 months. Analysis was by intention to treat.

RESULTS: A total of 221 participants (mean age 56 yrs) were recruited. 113 participants were randomized to US and 108 to placebo US. There was 76% follow up at 6 weeks and 71% at 6 months. The mean (95% CI) reduction in SDQ scores at 6 weeks was 17 points (13-26) for US and 13 points (9-17) for placebo US (P = 0.06). There were no statistically significant differences at the 5% level in mean changes between groups at any of the time points.

CONCLUSIONS: The addition of US was not superior to placebo US when used as part of a package of physiotherapy in the short-term management of shoulder pain. This has important implications for physiotherapy practice.

BACKGROUND: It is unknown whether the incidence of peptic ulcer changes in areas with a high prevalence of Helicobacter pylori infection.

AIM: To determine trends in peptic ulcer complications in a community with a high prevalence of H. pylori infection.

METHODS: New endoscopic diagnoses of peptic ulcers and their complications from 1985 to 2000 were obtained. H. pylori infection in the adult population, the number of prescriptions for anti-secretory drugs and non-steroidal anti-inflammatory drugs were also evaluated.

RESULTS: Although the global prevalence of H. pylori infection remains high in this population (>60%), a 41.4 to 25.4% decrease in the incidence of peptic ulcers and ulcer complications was observed. This was associated with a decrease in the prevalence of H. pylori infection in people under 65 years of age, a 3.5-fold increase in the number of prescriptions of proton-pump inhibitors and an increase in the number of prescriptions of non-steroidal anti-inflammatory drugs, especially coxibs.

CONCLUSIONS: In an area with a high prevalence of H. pylori infection, the incidence of peptic ulcer and associated complications is declining rapidly. This was associated with a reduction of the prevalence of H. pylori infection in the young and a widespread use of proton-pump inhibitors. The increase in the use of non-steroidal anti-inflammatory drugs, especially coxibs, has not changed the tendency.

OBJECTIVE: We conducted a pilot trial to assess the effect of botulinum toxin B on palmar pain and discomfort in carpal tunnel syndrome (CTS) patients. Design. Randomized, double-blind, placebo-controlled.

PATIENTS: Twenty ambulatory CTS patients. Intervention. Botulinum toxin B or placebo injections into three hypothenar muscles anatomically linked or attached to the carpal tunnel and its tentorium, that is, the Opponens Digiti Minimi and Flexor Digiti Minimi, located with electromyography (EMG), and the Palmaris Brevis Muscle, anatomically located without EMG.

SETTING: New York City hospital.

OUTCOME MEASURES: Outcomes were measured with numeric ratings, with higher scores indicating worse outcomes. Daily, subjects recorded their 0-10 numeric ratings of overall pain levels and pain-related sleep disturbances. During weekly telephone calls, they reported their 0-10 ratings for overall pain, pain-related sleep disturbance, and CTS-related tingling during the night and day as experienced over the preceding 24 hours. For each of four clinic visits, we averaged each subject's ratings of nine quality of life indicators from the West Haven-Yale Multidimensional Pain Inventory (WHYMPI), each measured on a 0-6 numeric scale.

RESULTS: Over the 13-week trial, compared to baseline scores, the following outcomes predominantly showed decreases of statistical significance (P < or = 0.050) or borderline significance (0.050 < P < or = 0.10) for weeks 2 through 8: overall pain per daily diary entries and per weekly telephone reports, and pain-related sleep disturbance in the placebo group per phone report and in the botulinum toxin B group per diary report. CTS painful night tingling and day tingling, as well as the average scores of the WHYMPI quality of life indicators, showed improvements with statistical or borderline significance for almost each follow-up week. Between-group analyses, however, demonstrated that at each follow-up week, there was no statistically significant difference between the two study groups regarding changes from baseline in any study outcome.

CONCLUSION: Botulinum toxin B is not dramatically superior to placebo for the relief of CTS symptoms. Possible explanations of the improvements in each study group are explored.

STUDY DESIGN: A Cochrane review of randomized controlled trials.

OBJECTIVES: To collate the scientific evidence on surgical management for lumbar-disc prolapse and degenerative lumbar spondylosis.

SUMMARY OF BACKGROUND DATA: Surgical investigations and interventions account for as much as one third of the health care costs for spinal disorders, but the scientific evidence for most procedures still is unclear.

METHODS: A highly sensitive search strategy identified all published randomized controlled trials. Cochrane methodology was used for meta-analysis of the results.

RESULTS: Twenty-six randomized controlled trials of surgery for lumbar disc prolapse and 14 trials of surgery for degenerative lumbar spondylosis were identified. Methodologic weaknesses were found in many of the trials. Only one trial directly compared discectomy and conservative management. Meta-analyses showed that surgical discectomy produces better clinical outcomes than chemonucleolysis, which is better than placebo. Three trials showed no difference in clinical outcomes between microdiscectomy and standard discectomy, but in three other studies, both produced better results than percutaneous discectomy. Three trials showed that inserting an interposition membrane after discectomy does not significantly reduce scar formation or alter clinical outcomes. Five heterogeneous trials on spinal stenosis and degenerative spondylolisthesis permit very limited conclusions. There were nine trials of instrumented versus noninstrumented fusion: Meta-analysis showed that instrumentation may facilitate fusion but does not improve clinical outcomes.

CONCLUSIONS: There is now strong evidence on the relative effectiveness of surgical discectomy versus chemonucleolysis versus placebo. There is considerable evidence on the clinical effectiveness of discectomy for carefully selected patients with sciatica caused by lumbar disc prolapse that fails to resolve with conservative management. There is no scientific evidence on the effectiveness of any form of surgical decompression or fusion for degenerative lumbar spondylosis compared with natural history, placebo, or conservative management. The Cochrane reviews will be updated continuously as other trials become available.

BACKGROUND: Chronic sleep-onset insomnia is a prevalent health complaint in adults. Although behavioral and pharmacological therapies have been shown to be effective for insomnia, no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia. The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy, singly and in combination, for chronic sleep-onset insomnia.

METHODS: This was a randomized, placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia. Interventions included cognitive behavior therapy (CBT), pharmacotherapy, or combination therapy compared with placebo. The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning.

RESULTS: In most measures, CBT was the most sleep effective intervention; it produced the greatest changes in sleep-onset latency and sleep efficiency, yielded the largest number of normal sleepers after treatment, and maintained therapeutic gains at long-term follow-up. The combined treatment provided no advantage over CBT alone, whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation.

CONCLUSIONS: These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia. Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia.

CONTEXT: Use of nonpharmacological behavioral therapy has been suggested for treatment of chronic primary insomnia, but well-blinded, placebo-controlled trials demonstrating effective behavioral therapy for sleep-maintenance insomnia are lacking.

OBJECTIVE: To test the efficacy of a hybrid cognitive behavioral therapy (CBT) compared with both a first-generation behavioral treatment and a placebo therapy for treating primary sleep-maintenance insomnia.

DESIGN AND SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted at a single academic medical center, with recruitment from January 1995 to July 1997.

PATIENTS: Seventy-five adults (n = 35 women; mean age, 55.3 years) with chronic primary sleep-maintenance insomnia (mean duration of symptoms, 13.6 years).

INTERVENTIONS: Patients were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; n = 25), progressive muscle relaxation training (RT; n = 25), or a quasi-desensitization (placebo) treatment (n = 25). Outpatient treatment lasted 6 weeks, with follow-up conducted at 6 months.

MAIN OUTCOME MEASURES: Objective (polysomnography) and subjective (sleep log) measures of total sleep time, middle and terminal wake time after sleep onset (WASO), and sleep efficiency; questionnaire measures of global insomnia symptoms, sleep-related self-efficacy, and mood.

RESULTS: Cognitive behavioral therapy produced larger improvements across the majority of outcome measures than did RT or placebo treatment. For example, sleep logs showed that CBT-treated patients achieved an average 54% reduction in their WASO whereas RT-treated and placebo-treated patients, respectively, achieved only 16% and 12% reductions in this measure. Recipients of CBT also showed a greater normalization of sleep and subjective symptoms than did the other groups with an average sleep time of more than 6 hours, middle WASO of 26.6 minutes, and sleep efficiency of 85.1%. In contrast, RT-treated patients continued to report a middle WASO of 43.3 minutes and sleep efficiency of 78.8%.

CONCLUSIONS: Our results suggest that CBT represents a viable intervention for primary sleep-maintenance insomnia. This treatment leads to clinically significant sleep improvements within 6 weeks and these improvements appear to endure through 6 months of follow-up.

INTRODUCTION: Cervical spine involvement is common and potentially severe in patients with rheumatoid arthritis (RA). The objectives of this study were to compare the prevalences of cervical spine abnormalities detected by standard radiography, computed tomography (CT), and magnetic resonance imaging (MRI) in patients with RA; and to identify factors associated with cervical spine involvement.

METHODS: We studied 40 patients who met American College of Rheumatology criteria for RA and had disease durations of 2 years or more. Each patient underwent a physical examination, laboratory tests, standard radiographs (anteroposterior, lateral, open-mouth, flexion, and extension views), MRI with dynamic maneuvers in (if not contraindicated), and CT.

RESULTS: Cervical spine involvement was found by at least one imaging technique in 29 (72.5%) patients (standard radiography, 47.5%; CT, 28.2%; and MRI, 70%) and was asymptomatic in 5 (17.2%) patients. C1-C2 pannus was the most common lesion (62.5% of cases), followed by atlantoaxial subluxation (AAS, 45%). The most common AAS pattern was anterior subluxation (25%), followed by lateral subluxation (15%) then by vertical, rotatory, and subaxial subluxations (10% each). Erosions of the dens were seen in 67.5% of patients by MRI, 41% by CT, and 12.5% by standard radiography. Of the 10 cases of anterior AAS by any modality, 9 were detected by standard radiography and 7 by MRI. CT was the best technique for visualizing atypical rotatory or lateral AAS. MRI was best for assessing the C1-C2 pannus, dens erosions, and neurologic impact of the rheumatoid lesions. The comparison of patients with and without cervical spine lesions suggested that higher modified Sharp score and C-reactive protein values predicted cervical spine involvement (P=0.002 and P=0.004, respectively).

CONCLUSION: Cervical spine involvement is common and may be asymptomatic, indicating that routine cervical spine imaging is indicated in patients with RA. Standard radiography including dynamic views constitutes the first-line imaging method of choice. Sensitivity and comprehensiveness of the assessment are greatest with MRI. MRI and CT are often reserved for selected patients. Cervical spine involvement is associated with disease activity and with rapidly progressive joint destruction.

OBJECTIVE: To investigate the therapeutic effects of physical agents administered before isokinetic exercise in women with knee osteoarthritis.

DESIGN: One hundred patients with bilateral knee osteoarthritis were randomized into five groups of 20 patients each: group 1 received short-wave diathermy + hot packs and isokinetic exercise; group 2 received transcutaneous electrical nerve stimulation + hot packs and isokinetic exercise; group 3 received ultrasound + hot packs and isokinetic exercise; group 4 received hot packs and isokinetic exercise; and group 5 served as controls and received only isokinetic exercise.

RESULTS: Pain and disability index scores were significantly reduced in each group. Patients in the study groups had significantly greater reductions in their visual analog scale scores and scores on the Lequesne index than did patients in the control group (group 5). They also showed greater increases than did controls in muscular strength at all angular velocities. In most parameters, improvements were greatest in groups 1 and 2 compared with groups 3 and 4.

CONCLUSIONS: Using physical agents before isokinetic exercises in women with knee osteoarthritis leads to augmented exercise performance, reduced pain, and improved function. Hot pack with a transcutaneous electrical nerve stimulator or short-wave diathermy has the best outcome.

BACKGROUND: Chronic low back pain is a common problem that has only modestly effective treatment options.

OBJECTIVE: To determine whether yoga is more effective than conventional therapeutic exercise or a self-care book for patients with chronic low back pain.

DESIGN: Randomized, controlled trial.

SETTING: A nonprofit, integrated health care system.

PATIENTS: 101 adults with chronic low back pain.

INTERVENTION: 12-week sessions of yoga or conventional therapeutic exercise classes or a self-care book.

MEASUREMENTS: Primary outcomes were back-related functional status (modified 24-point Roland Disability Scale) and "bothersomeness" of pain (11-point numerical scale). The primary time point was 12 weeks. Clinically significant change was considered to be 2.5 points on the functional status scale and 1.5 points on the bothersomeness scale. Secondary outcomes were days of restricted activity, general health status, and medication use.

RESULTS: After adjustment for baseline values, back-related function in the yoga group was superior to the book and exercise groups at 12 weeks (yoga vs. book: mean difference, -3.4 [95% CI, -5.1 to - 1.6] [P < 0.001]; yoga vs. exercise: mean difference, -1.8 [CI, -3.5 to - 0.1] [P = 0.034]). No significant differences in symptom bothersomeness were found between any 2 groups at 12 weeks; at 26 weeks, the yoga group was superior to the book group with respect to this measure (mean difference, -2.2 [CI, -3.2 to - 1.2]; P < 0.001). At 26 weeks, back-related function in the yoga group was superior to the book group (mean difference, -3.6 [CI, -5.4 to - 1.8]; P < 0.001).

LIMITATIONS: Participants in this study were followed for only 26 weeks after randomization. Only 1 instructor delivered each intervention.

CONCLUSIONS: Yoga was more effective than a self-care book for improving function and reducing chronic low back pain, and the benefits persisted for at least several months.

PURPOSE: In many physical therapy programs for subjects with adhesive capsulitis of the shoulder, mobilization techniques are an important part of the intervention. The purpose of this study was to compare the effectiveness of high-grade mobilization techniques (HGMT) with that of low-grade mobilization techniques (LGMT) in subjects with adhesive capsulitis of the shoulder.

SUBJECTS: One hundred subjects with unilateral adhesive capsulitis lasting 3 months or more and a > or =50% decrease in passive joint mobility relative to the nonaffected side were enrolled in this study.

METHODS: Subjects randomly assigned to the HGMT group were treated with intensive passive mobilization techniques in end-range positions of the glenohumeral joint, and subjects in the LGMT group were treated with passive mobilization techniques within the pain-free zone. The duration of treatment was a maximum of 12 weeks (24 sessions) in both groups. Subjects were assessed at baseline and at 3, 6, and 12 months by a masked assessor. Primary outcome measures included active and passive range of motion and shoulder disability (Shoulder Rating Questionnaire [SRQ] and Shoulder Disability Questionnaire [SDQ]). An analysis of covariance with adjustments for baseline values and a general linear mixed-effect model for repeated measurements were used to compare the change scores for the 2 treatment groups at the various time points and over the total period of 1 year, respectively.

RESULTS: Overall, subjects in both groups improved over 12 months. Statistically significant greater change scores were found in the HGMT group for passive abduction (at the time points 3 and 12 months), and for active and passive external rotation (at 12 months). A statistically significant difference in trend between both groups over the total follow-up period of 12 months was found for passive external rotation, SRQ, and SDQ with greater change scores in the HGMT group.

CONCLUSION: In subjects with adhesive capsulitis of the shoulder, HGMTs appear to be more effective in improving glenohumeral joint mobility and reducing disability than LGMTs, with the overall differences between the 2 interventions being small.

BACKGROUND AND PURPOSE: In many physical therapy programs for subjects with adhesive capsulitis of the shoulder, mobilization techniques are an important part of the intervention. The purpose of this study was to compare the effectiveness of high-grade mobilization techniques (HGMT) with that of low-grade mobilization techniques (LGMT) in subjects with adhesive capsulitis of the shoulder.

SUBJECTS: One hundred subjects with unilateral adhesive capsulitis lasting 3 months or more and a > or =50% decrease in passive joint mobility relative to the nonaffected side were enrolled in this study.

METHODS: Subjects randomly assigned to the HGMT group were treated with intensive passive mobilization techniques in end-range positions of the glenohumeral joint, and subjects in the LGMT group were treated with passive mobilization techniques within the pain-free zone. The duration of treatment was a maximum of 12 weeks (24 sessions) in both groups. Subjects were assessed at baseline and at 3, 6, and 12 months by a masked assessor. Primary outcome measures included active and passive range of motion and shoulder disability (Shoulder Rating Questionnaire [SRQ] and Shoulder Disability Questionnaire [SDQ]). An analysis of covariance with adjustments for baseline values and a general linear mixed-effect model for repeated measurements were used to compare the change scores for the 2 treatment groups at the various time points and over the total period of 1 year, respectively.

RESULTS: Overall, subjects in both groups improved over 12 months. Statistically significant greater change scores were found in the HGMT group for passive abduction (at the time points 3 and 12 months), and for active and passive external rotation (at 12 months). A statistically significant difference in trend between both groups over the total follow-up period of 12 months was found for passive external rotation, SRQ, and SDQ with greater change scores in the HGMT group.

DISCUSSION AND CONCLUSION: In subjects with adhesive capsulitis of the shoulder, HGMTs appear to be more effective in improving glenohumeral joint mobility and reducing disability than LGMTs, with the overall differences between the 2 interventions being small.

PRINCIPLE: A randomised, comparative prospective clinical trial was planned to compare the early response to different rehabilitation methods for adhesive capsulitis taking into consideration the clinical efficacy and the cost effectiveness of the methods.

METHODS: Forty patients with adhesive capsulitis were randomised into two treatment groups. The first group (CYR) received the Cyriax approach of deep friction massage and mobilisation exercises three times weekly. The second group (PT) had daily physical therapy including hot pack and short wave diathermy application. Both groups concluded their treatments with stretching exercises and were also instructed to a daily home exercise program. The primary end point of the study was to reach 80% of the normal passive range of motion (ROM) of the shoulder in all planes within a period of two weeks. Secondary end points were the overall ROM and pain response (spontaneous pain, night pain and pain with motion) to each treatment.

RESULTS: 19 patients in the CYR group (95%) and 13 patients in the PT group (65%) reached sufficient ROM at the end of the second week (p <0.05). The improvement in shoulder flexion, inner and outer rotation values and the decrease in pain with motion were significantly better in the CYR group after the first week of treatment.

CONCLUSION: The Cyriax method of rehabilitation provides a faster and better response than the conventional physical therapy methods in the early phase of treatment in adhesive capsulitis. The method is non-invasive, effective and requires fewer hospital visits for a sufficient early response.