Predictors of the effects of treatment for shoulder pain: protocol of an individual participant data meta-analysis.

BACKGROUND: Shoulder pain is one of the most common presentations of musculoskeletal pain with a 1-month population prevalence of between 7 and 26%. The overall prognosis of shoulder pain is highly variable with 40% of patients reporting persistent pain 1 year after consulting their primary care clinician. Despite evidence for prognostic value of a range of patient and disease characteristics, it is not clear whether these factors also predict (moderate) the effect of specific treatments (such as corticosteroid injection, exercise, or surgery). OBJECTIVES: This study aims to identify predictors of treatment effect (i.e. treatment moderators or effect modifiers) by investigating the association between a number of pre-defined individual-level factors and the effects of commonly used treatments on shoulder pain and disability outcomes. METHODS: This will be a meta-analysis using individual participant data (IPD). Eligible trials investigating the effectiveness of advice and analgesics, corticosteroid injection, physiotherapy-led exercise, psychological interventions, and/or surgical treatment in patients with shoulder conditions will be identified from systematic reviews and an updated systematic search for trials, and risk of bias will be assessed. Authors of all eligible trials will be approached for data sharing. Outcomes measured will be shoulder pain and disability, and our previous work has identified candidate predictors. The main analysis will be conducted using hierarchical one-stage IPD meta-analysis models, examining the effect of treatment-predictor interaction on outcome for each of the candidate predictors and describing relevant subgroup effects where significant interaction effects are detected. Random effects will be used to account for clustering and heterogeneity. Sensitivity analyses will be based on (i) exclusion of trials at high risk of bias, (ii) use of restricted cubic splines to model potential non-linear associations for candidate predictors measured on a continuous scale, and (iii) the use of a two-stage IPD meta-analysis framework. DISCUSSION: Our study will collate, appraise, and synthesise IPD from multiple studies to examine potential predictors of treatment effect in order to assess the potential for better and more efficient targeting of specific treatments for individuals with shoulder pain. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018088298.

Radiating low back pain in general practice: incidence, prevalence, diagnosis, and long-term clinical course of illness.

OBJECTIVE: The aim of this study was to calculate the incidence and prevalence of radiating low back pain, to explore the long-term clinical course of radiating low back pain including the influence of radiculopathy (in a subsample of the study population) and non-radiating low back pain thereon, and to describe general practitioners' (GPs') treatment strategies for radiating low back pain. DESIGN: A historic prospective cohort study. SETTING: Dutch general practice. SUBJECTS: Patients over 18 years of age with a first episode of radiating low back pain, registered by the ICPC code L86. MAIN OUTCOME MEASURES: Incidence and prevalence, clinical course of illness, initial diagnoses established by the GPs, and treatment strategies. RESULTS: Mean incidence was 9.4 and mean prevalence was 17.2 per 1000 person years. In total, 390 patients had 1193 contacts with their GPs; 50% had only one contact with their GP. Consultation rates were higher in patients with a history of non-radiating low back pain and in patients with a diagnosis of radiculopathy in the first five years. In this study's subsample of 103 patients, L86 episodes represented radiculopathy in 50% of cases. Medication was prescribed to 64% of patients, mostly NSAIDs. Some 53% of patients were referred, mainly to physiotherapists and neurologists; 9% of patients underwent surgery. CONCLUSION: Watchful waiting seems to be sufficient general practice care in most cases of radiating low back pain. Further research should be focused on clarifying the relationship between radicular radiating low back pain, non-radicular radiating low back pain, and non-radiating low back pain.

Epidural steroids for lumbosacral radicular syndrome compared to usual care: quality of life and cost utility in general practice.

OBJECTIVE: To investigate the effect of adding segmental epidural steroid injections (SESIs) to usual care compared with usual care alone on quality of life and cost utility in lumbosacral radicular syndrome (LRS) in general practice. DESIGN: A pragmatic randomized controlled trial. Results were analyzed using mixed models. SETTING: Primary care. PARTICIPANTS: Patients (N=50) in the acute phase of LRS. INTERVENTIONS: One epidural injection containing 80mg of triamcinolone in normal saline. MAIN OUTCOME MEASURE: Back pain at 4 weeks after the start of the treatment. RESULTS: Both groups experienced a significant increase in quality of life in (especially) the physical domains of the Medical Outcomes Study 36-Item Short-Form Health Survey. The intervention group scored significantly better than the control group at certain time points in the physical domain. The differences were small. The cost-utility analysis showed that with a negligible loss of utility (3d in perfect health), societal costs (193,354 euros per quality-adjusted life year lost) would be saved because of more productivity in the intervention group. CONCLUSIONS: Although the beneficial effects of SESIs are small and the natural course of LRS is predominantly favorable, we think decision makers can consider implementing SESIs in daily practice with the purpose of saving resources. Caution must be taken, and further research should be directed at identifying patient subgroups who might benefit from SESIs, with additional focus on (costs of) complications and adverse effects.

Steroid injections added to the usual treatment of lumbar radicular syndrome: a pragmatic randomized controlled trial in general practice.

BACKGROUND: Lumbosacral radicular syndrome (LRS) is a self-limiting, benign, painful and impairing condition caused by lumbar disc herniation and inflammatory processes around the nerve root. Segmental epidural steroid injections (SESIs) are helpful to reduce radicular pain on a short-term basis. It is unknown whether SESIs are an effective addition to usual pain treatment of LRS in general practice. In our study, we assessed the effectiveness of SESIs on pain and disability as an addition to usual care for acute LRS in general practice. METHODS: A pragmatic, single-blinded, randomized controlled trial in Dutch general practice was conducted. Circumstances of daily practice were closely followed. Care as usual (CAU) was compared to care as usual combined with an additional SESI in 63 patients in the acute phase of LRS. To detect a minimal clinically important difference of 1.2 points on a numerical rating scale for back pain and a common within-group standard deviation of 1.7 with a two-tailed alpha of 0.05 and a power of 0.80, we needed 33 subjects in each group. Statistical analysis was carried out using mixed models. RESULTS: A small significant effect in favour of the intervention, corrected for age, sex and baseline values, was found for back pain, impairment and Roland-Morris disability score. The differences, though statistically significant, were too small to be considered clinically relevant. Patients from the intervention group were significantly more satisfied with the received treatment than patients from the control group. CONCLUSION: We found a small, statistically significant, but not clinically relevant positive effect of SESIs on back pain, impairment and disability in acute LRS. We do not recommend implementing SESIs as an additional regular treatment option in general practice.

Costs and cost-effectiveness of epidural steroids for acute lumbosacral radicular syndrome in general practice: an economic evaluation alongside a pragmatic randomized control trial.

STUDY DESIGN: A pragmatic, randomized, controlled, single-blinded trial in Dutch general practice. OBJECTIVE: Assessing the costs and cost-effectiveness of adding segmental epidural steroid injections to care as usual in radiculopathy in general practice. SUMMARY OF BACKGROUND DATA: Lumbosacral radicular syndrome (radiculopathy) is a benign, generally self-limiting but painful condition caused by a herniated lumbar intervertebral disc, which results in an inflammatory process around the nerve root. Segmental epidural steroid injections could lessen pain. Low back pain and sciatica form a large financial burden on national health care systems. Improving pain treatment could lower costs to society by diminishing loss of productivity. METHODS: Patients with acute radiculopathy were included by general practitioners. All patients received usual care. Patients in the intervention group received one segmental epidural steroid injection containing 80 mg of triamcinolone as well. Follow-up was performed using postal questionnaires at 2, 4, 6, 13, 26, and 52 weeks. Main outcomes were pain, disability and costs. Economic evaluation was performed from a societal perspective with a time horizon of 1 year. RESULTS: Sixty-three patients were included in the analysis. Mean total costs were €4414 or $5985 in the intervention group and €5121 or $6943 in the control group. This difference was mostly due to loss of productivity. The point estimate for the incremental cost-effectiveness ratio was -€730 or -$990 (1-point diminishment on the numerical rating scale back pain score in 1 patient in the course of 1 yr would save €730 or $990). Bootstrapping showed a 95% confidence interval of -€4476 to €951 or -$6068 to $1289. The cost-effectiveness acceptability curve showed that without additional investment the probability that epidural steroids are cost-effective is more than 80%. CONCLUSION: The effect on pain and disability of epidural steroids in lumbosacral radicular syndrome is small but significant, and at lower costs with no reported complications or adverse effects. Segmental epidural steroid injections could be considered by policy makers as an additional treatment option.

Patients with shoulder complaints in general practice: consumption of medical care.

OBJECTIVE: To describe the medical consumption [general practitioner (GP) consultation, referrals, medication consumption] of patients with shoulder complaints in general practice. METHODS: Data were obtained from a primary-care medical registration network. All patients aged ≥18 years with new shoulder complaints who consulted their general practitioner in 1998 were included, and were followed 10 years beyond the initial consultation. RESULTS: A total of 526 incident cases were identified (average age 47 years, 65% women and average follow-up 7.6 years). Nearly half of the patients consulted their GP only once. For 79% of those patients, a wait-and-see policy or a prescription for NSAIDs sufficed. During follow-up, 65% of all patients were prescribed medication. Medication consumption was significantly higher among men than women, and higher for the 45- to 64-year age group compared with the younger group. A total of 199 patients were referred, of which 84% was to a physiotherapist and 16% to secondary care. Only two patients had surgery, performed by an orthopaedic surgeon. The GP recorded a diagnosis in only 14% of patients; rotator cuff disorder being the most common. CONCLUSIONS: Nearly half of patients with a new shoulder complaint consult their GP only once. Medical consumption in general practice is highest for male shoulder patients and the 45- to 64-year age group. Shoulder problems are mainly an issue for primary care.

Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice.

BACKGROUND: Carpal tunnel syndrome is caused by entrapment of the median nerve and results in pain, tingling and numbness in the wrist and hand. It is a common condition in general practice. Effectiveness of treatment by intracarpal corticosteroid injection has never been investigated in general practice. The objective of this study was to determine if corticosteroid injections for carpal tunnel syndrome provided by general practitioners are effective. METHODS: In this study 69 participants with a clinical diagnosis of carpal tunnel syndrome were recruited from 20 general practices. Short-term outcomes were assessed in a randomised, placebo-controlled trial. Long-term results were assessed in a prospective cohort-study of steroid responders. Participants were randomised to intracarpal injections of 1 ml triamcinolonacetonide 10 mg/ml (TCA) or 1 ml NaCl (placebo). Non-responders to NaCl were treated with additional TCA injections. Main outcomes were immediate treatment success, mean score of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS) of the Boston carpal tunnel questionnaire, subjective improvement and proportion of participants with recurrences during follow-up. Duration of follow-up was twelve months. RESULTS: The TCA-group (36 participants) had better outcomes than the NaCl-group (33 participants) during short-term assessment for outcome measures treatment response, mean improvement of SSS-score (the mean difference in change score was 0.637 {95% CI: 0.320, 0.960; p < 0.001}) and FSS-score (the mean difference in change score was 0.588 {95% CI: 0.232, 0.944; p = 0.002}) and perceived improvement (p = 0.01). The number to treat to achieve satisfactory partial treatment response or complete resolution of symptoms and signs was 3 (95% CI:1.83, 9.72).49% of TCA-responders (17/35) had recurrences during follow-up. In the group of TCA-responders without recurrences (51%, 18/35) outcomes for SSS-score and FSS-score deteriorated during the follow-up period of 12 months (resp. p = 0.008 and p = 0.012). CONCLUSIONS: Corticosteroid injections for CTS provided by general practitioners are effective regarding short-term outcomes when compared to placebo injections. The short-term beneficial treatment effects of steroid injections deteriorated during the follow-up period of twelve months and half of the cohort of steroid-responders had recurrences. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53171398.

Manipulative therapy in addition to usual care for patients with shoulder complaints: results of physical examination outcomes in a randomized controlled trial.

OBJECTIVE: The purpose of this study was to examine the effect of manipulative therapy on the shoulder girdle, in addition to usual care provided by the general practitioner, on the outcomes of physical examination tests for the treatment of shoulder complaints. METHODS: This was a randomized controlled trial in a primary care setting in the Netherlands. A total of 150 participants were recruited from December 2000 until December 2002. All patients received usual care by the general practitioner. Usual care included one or more of the following depending on the needs of the patient: information/advice, oral analgesics or nonsteroidal antiinflammatory drugs, corticosteroid injections, exercises, and massage. In addition to usual care, the intervention group received manipulative therapy, up to 6 treatment sessions in a 12-week period. Twenty-four physical examination tests were done at baseline and after 6, 12, and 26 weeks. Factor analysis was done to reduce the number of outcome measures. RESULTS: The factor analysis resulted in 4 factors: "shoulder pain," "neck pain," "shoulder mobility," and "neck mobility." At 6 weeks, no significant differences between groups were found. At 12 weeks, the mean changes of all 4 factors favored the intervention group; the factors "shoulder pain" and "neck pain" reached statistical significance (95% confidence interval [CI], 0.1-2.1). At 26 weeks, differences in the factors "shoulder pain" (95% CI, 0.0-2.6), "shoulder mobility" (95% CI, 0.2-1.7), and "mobility neck" (95% CI, 0.2-1.3) statistically favored the intervention group. CONCLUSION: In this pragmatic study, manipulative therapy, in addition to usual care by the general practitioner, diminished severity of shoulder pain and neck pain and improved shoulder and neck mobility.

Randomised controlled trial of local corticosteroid injections for de Quervain's tenosynovitis in general practice.

BACKGROUND: De Quervain's tenosynovitis is a stenosing tenosynovitis of the first dorsal compartment of the wrist and leads to wrist pain and to impaired function of the wrist and hand. It can be treated by splinting, local corticosteroid injection and operation. In this study effectiveness of local corticosteroid injections for de Quervain's tenosynovitis provided by general practitioners was assessed. METHODS: Participants with de Quervain's tenosynovitis were recruited by general practitioners. Short-term outcomes (one week after injections) were assessed in a randomised, placebo-controlled trial. Long-term effectiveness was evaluated in an open prospective cohort-study of steroid responders during a follow-up period of 12 months. Participants were randomised to one or two local injections of 1 ml of triamcinolonacetonide (TCA) or 1 ml of NaCl 0.9% (placebo). Non-responders to NaCl were treated with additional TCA injections. Main outcomes were immediate treatment response, severity of pain, improvement as perceived by participant and functional disability using sub items hand and finger function of the Dutch Arthritis Impact Measurement Scale (Dutch AIMS-2-HFF). RESULTS: 11 general practitioners included 21 wrists in 21 patients. The TCA-group had better results for short-term outcomes treatment response (78% vs. 25%; p = 0.015), perceived improvement (78% vs. 33%; p = 0.047) and severity of pain (4.27 vs. 1.33; p = 0.031) but not for the Dutch-AIMS-HFF (2.71 vs. 1.92; p = 0.112). Absolute risk reduction for the main outcome short-term treatment response was 0.55 (95% CI: 0.34, 0.76) with a number needed to treat of 2 (95% CI: 1, 3). In the cohort of steroid responders (n = 12) the beneficial effects of steroid injections were sustained during the follow-up of 12 months regarding severity of pain (p = 0.67) and scores of Dutch AIMS-2-HFF (p = 0.36), but not for patient perceived improvement (p = 0.02). No adverse events were observed during the 12 months of follow-up. CONCLUSION: One or two local injections of 1 ml triamcinolonacetonide 10 mg/ml provided by general practitioners leads to improvement in the short term in participants with de Quervain's tenosynovitis when compared to placebo. The short-term beneficial effects of steroid injections for symptoms were maintained during the follow-up after 12 months. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53171398.

Corticosteroid injection for de Quervain's tenosynovitis.

BACKGROUND: De Quervain's tenosynovitis is a disorder characterised by pain on the radial (thumb) side of the wrist and functional disability of the hand. It can be treated by corticosteroid injection, splinting and surgery. OBJECTIVES: To summarise evidence on the efficacy and safety of corticosteroid injections for de Quervain's tenosynovitis. SEARCH STRATEGY: We searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 2), MEDLINE (1966 to April 2009), EMBASE (1956 to April 2009), CINAHL (1982 to April 2009), AMED (1985 to April 2009), DARE, Dissertation Abstracts and PEDro (physiotherapy evidence database). SELECTION CRITERIA: Randomised and controlled clinical trials evaluating the efficacy and safety of corticosteroid injections for de Quervain's tenosynovitis. DATA COLLECTION AND ANALYSIS: After screening abstracts of studies identified by the search we obtained full text articles of studies which fulfilled the selection criteria. We extracted data using a predefined electronic form. We assessed the methodological quality of included trials by using the checklist developed by Jadad and the Delphi list. We extracted data on the primary outcome measures: treatment success; severity of pain or tenderness at the radial styloid; functional impairment of the wrist or hand; and outcome of Finkelstein's test, and the secondary outcome measures: proportion of patients with side effects; type of side effects and patient satisfaction with injection treatment. MAIN RESULTS: We found one controlled clinical trial of 18 participants (all pregnant or lactating women) that compared one steroid injection with methylprednisolone and bupivacaine to splinting with a thumb spica. All patients in the steroid injection group (9/9) achieved complete relief of pain whereas none of the patients in the thumb spica group (0/9) had complete relief of pain, one to six days after intervention (number needed to treat to benefit (NNTB) = 1, 95% confidence interval (CI) 0.8 to 1.2). No side effects or local complications of steroid injection were noted. AUTHORS' CONCLUSIONS: The efficacy of corticosteroid injections for de Quervain's tenosynovitis has been studied in only one small controlled clinical trial, which found steroid injections to be superior to thumb spica splinting. However, the applicability of our findings to daily clinical practice is limited, as they are based on only one trial with a small number of included participants, the methodological quality was poor and only pregnant and lactating women participated in the study. No adverse effects were observed.

Manipulative therapy and clinical prediction criteria in treatment of acute nonspecific low back pain.

Manipulative therapy as part of a multidimensional approach may be more effective than standard physical therapy in treating Acute Nonspecific Low Back Pain. 64 participants, 29 women and 35 men, with Acute Nonspecific Low Back Pain and a mean age of 40 yr. (SD=9.6) were randomly assigned to two groups: an experimental group (manipulative therapy plus physical therapy) and a control group (only physical therapy). A multicentre, nonblinded, randomised clinical trial was conducted. Pain relief was the main performance criteria measured together with secondary criteria which included functional status and mobility of the lower back. Fritz, Childs, and Flynn's clinical prediction rule--a duration of symptoms less than 16 days, no pain distal of the knee--was used to analyse the results. In combination with an age >35 years, results showed a statistical significant effect for disability, but no statistically significant benefit of additional manipulative therapy over physical therapy found for pain and mobility within 4 treatments. Controlled for the applied clinical prediction rule, there were statistically significant interaction effects with low effect size for disability and sex, but no significant effects were found for pain of mobility.

Conservative or surgical treatment for subacromial impingement syndrome? A systematic review.

BACKGROUND: Patients with subacromial impingement syndrome are often operated on when conservative treatments fail. But does surgery really lead to better results than nonoperative measures? This systematic review compared effects of conservative and surgical treatment for subacromial impingement syndrome in terms of improvement of shoulder function and reduction of pain. METHODS: A literature search for randomized controlled trials (RCTs) in PubMed, EMBASE, PEDro, and the Cochrane Central Register of Controlled Trials was conducted. Two reviewers assessed the methodological quality of the selected studies. A best-evidence synthesis was used to summarize the results. RESULTS: Four RCTs were included in this review. Two RCTs had a medium methodological quality, and 2 RCTS had a low methodological quality. No differences in outcome between the treatment groups were reported for any of the studies, irrespective of quality. CONCLUSION: No high-quality RCTs are available so far to provide possible evidence for differences in outcome; therefore, no confident conclusion can be made. According to the best-evidence synthesis, however, there is no evidence from the available RCTs for differences in outcome in pain and shoulder function between conservatively and surgically treated patients with SIS. LEVEL OF EVIDENCE: Review.

Corticosteroid injection for trigger finger in adults.

BACKGROUND: Trigger finger is a disease of the tendons of the hand leading to triggering (locking) of affected fingers, dysfunction and pain. Available treatments include local injection with corticosteroids, surgery, or splinting. OBJECTIVES: To summarize the evidence on the efficacy and safety of corticosteroid injections for trigger finger in adults using the following endpoints: treatment success, frequency of triggering or locking, functional status of the affected fingers, and severity of pain of the fingers. SEARCH STRATEGY: The databases CENTRAL, DARE, MEDLINE (1966 to November 2007), EMBASE (1956 to November 2007), CINAHL (1982 to November 2007), AMED (1985 to November 2007) and PEDro (a physiotherapy evidence database) were searched. SELECTION CRITERIA: We selected randomized and controlled clinical trials evaluating efficacy and safety of corticosteroid injections for trigger finger in adults. DATA COLLECTION AND ANALYSIS: The databases were searched for titles of eligible studies. After screening abstracts of these studies, full text articles of studies which fulfilled the selection criteria were obtained. Data were extracted using a predefined electronic form. The methodological quality of included trials was assessed by using items from the checklist developed by Jadad and the Delphi list. We planned to extract data regarding information on the primary outcome measures: treatment success, frequency of triggering or locking, and functional impairment of fingers, severity of the trigger finger; and the secondary outcome measures: proportion of patients with side effects, types of side effects, and patient satisfaction with injection. MAIN RESULTS: Two randomized controlled studies were found that involved 63 participants: 34 were allocated to corticosteroids and lidocaine, and 29 were allocated to lidocaine alone. Corticosteroid injection with lidocaine was more effective than lidocaine alone on treatment success at four weeks (relative risk 3.15, 95% CI 1.34 to 7.40). The number needed to treat to benefit was 3. No adverse events or side effects were reported. AUTHORS' CONCLUSIONS: The effectiveness of local corticosteroid injections was studied in only two small randomized controlled trials of poor methodological quality. Both studies showed better short-term effects of corticosteroid injection combined with lidocaine compared to lidocaine alone on the treatment success outcome. In one study the effects of corticosteroid injections lasted up to four months. No adverse effects were observed. The available evidence for the effectiveness of intra-tendon sheath corticosteroid injection for trigger finger can be graded as a silver level evidence for superiority of corticosteroid injections combined with lidocaine over injections with lidocaine alone.

Interobserver reliability of physical examination of shoulder girdle.

The object of this study was to assess interobserver reliability in 23 tests concerning physical examination of the shoulder girdle. A physical therapist and a physical therapist/manual therapist independently performed a physical examination of the shoulder girdle in 91 patients with shoulder complaints of varying severity and duration. The observers assessed 23 items in total: active and passive abductions, passive external rotation, hand in neck (HIN) test, hand in back (HIB) test, impingement test according to Neer, springing test of the first rib and joint play test of the acromioclavicular joint. The interobserver reliability was evaluated by means of a Cohen's Kappa, the weighted Kappa and the intraclass correlation (ICC). Criteria for acceptable reliability were: Kappa value>or=0.60, ICC>or=0.75 or an absolute agreement>or=80%. The results showed that Kappa values varied from 0.09 (springing test first rib, stiffness) to 0.66 (springing test first rib, pain), weighted Kappa varied from 0.35 (pain during HIB) to 0.73 (range of motion HIB) and ICC varied from 0.54 (abduction passive starting point painful arc) to 0.96 (active and passive ranges of motion in abduction). In total 11 (48%) items fulfilled the criteria of acceptable reliability. In conclusion, there appears to be a great deal of variation in the reliability of the tests used in the physical examination of the shoulder girdle. Over 50% of the tests did not meet the statistical criteria for acceptable reliability.

Assessment of the cervical range of motion over time, differences between results of the Flock of Birds and the EDI-320: a comparison between an electromagnetic tracking system and an electronic inclinometer.

The objective of this study was to analyse cervical range of motion, assessed over time by means of a digital inclinometer (EDI-320) and a three-dimensional electromagnetic tracking device (Flock of Birds). The maximum active cervical range of motion was assessed with two measurement devices in three sessions over time, with 6-week intervals. In total, 26 women and 24 men (mean age: 44.4, SD: 9.9) without known pathology of the cervical spine participated. Four movements were measured axial rotation with the cervical spine in a flexed and in an extended position, flexion-extension, and lateral bending. The results showed that the factor time was significant for rotation in extension and rotation in flexion. The factor device was significant for all movements measured, and the interaction term between time and device was significant for all movements except rotation in extension. The Flock of Birds measured significantly higher ranges of motion on all motions except for lateral bending. A substantial variation in cervical range of motion was observed over time (ranging from -5.6 to 8.1) as well as between devices (ranging from -13.1 to 29.9). Substantial and significant differences in cervical range of motion were found over time as well as differences between the Flock of Birds and the EDI-320.

A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial.

BACKGROUND: Subacromial impingement syndrome (SIS) is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages - unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT), which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery. METHODS/DESIGN: The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT). Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group) or continuation of usual medical care (control group). The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses. DISCUSSION: The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial impingement syndrome are presented. The results of this study will improve insight into the best moment of referral for surgery for SIS.

Patients' views on dyspepsia and acid suppressant drug therapy in general practice.

OBJECTIVES: To do an inventory on the opinion of long-term acid suppressant drug (ASD) users on their condition and drug treatment, and from that angle to reflect on possibilities to reduce usage and costs of long-term acid suppressant drug therapy. METHODS: In the year 2001, in seven general practices, patients who chronically used ASDs without proper indication were identified. A postal questionnaire based on the literature was sent to these patients (n=498). RESULTS: 318 (64%) returned questionnaires were fit for analysis. Patients experienced dyspepsia as unpleasant and restraining, and were extremely positive about ASDs without differences between H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). ASD use was very compliant. Patients smoked and drank less than the normal population. They did not continue unhealthy habits simply because ASDs enable them to. Most patients were not motivated to stop their ASDs. CONCLUSION: Dyspeptic complaints should not be underestimated. Improving lifestyle is not likely to generate much effect on ASD use. Due to a lack of motivation, discontinuing long-term ASD use may not be an efficient way to reduce the use and costs of ASDs. Patient-centred possibilities are prescribing H2RAs instead of PPIs as a first step, as they are perceived by patients to be equally effective, and encouraging patients to self-regulate drug treatment through on-demand regimes.

A simple classification system was recommended for patients with restricted shoulder or neck range of motion.

OBJECTIVE: To construct an empirical classification of patients with shoulder complaints, and then to investigate the relationship between the empirical classification and the setting in which the patients were recruited, their demographic and clinical characteristics, and the original diagnostic categories. STUDY DESIGN AND SETTING: A latent class analysis was performed on the combined data of two previous studies. RESULTS: Four clusters of patients emerged, one with patients who have a small chance of any restriction of the motion of the shoulder and a moderate chance of restriction of the motions of the neck, a second with patients who have a high chance of restriction of the motions of the shoulder and a moderate chance of restriction of motions of the neck, a third with patients who have a low to moderate chance of restriction of all motions, and a fourth with patients who have a high chance of restriction of all of the motions. Patients recruited from a clinic for rheumatology and rehabilitation and from the orthopedic clinic were more present in the second cluster. Patients in the third cluster were on average younger than those in the other clusters. There appeared to be little agreement between the clusters found and the classification of patients according to the original diagnostic categories. CONCLUSION: Patients experiencing shoulder pain can be classified in a simple way into four categories, reflecting the distinction between problems of the shoulder and those of the neck. A simple classification rule is proposed with which almost all patients can be classified into the four clusters.

Interobserver reliability of neck-mobility measurement by means of the flock-of-birds electromagnetic tracking system.

OBJECTIVE: To establish the interobserver reliability for measuring neck mobility in human subjects by means of an electromagnetic tracking device, the Flock-of-Birds system. METHODS: Two observers independently and in random order assessed the cervical range-of-motion in 30 subjects with a dysfunction in the neck and shoulder region (symptomatic subjects) and 30 subjects without known pathology (asymptomatic subjects). Measurements included rotation in neutral position, in flexed position and in extended position, flexion-extension, and lateral bending (all active and passive). Reliability was analyzed by intraclass correlation coefficient (ICC) and agreement by limits of agreement and percentage of paired observations within 5 degrees, 10 degrees, and 15 degrees. RESULTS: For asymptomatic subjects, the ICC varied from 0.57 to 0.85, and the limits of agreement varied between 14.5 degrees and 27.0 degrees. The percentage of paired observations within 5 degrees, 10 degrees, and 15 degrees ranged from 31% to 57%, 58% to 90%, and 78% to 93%, respectively. For symptomatic subjects, the ICC varied from 0.36 to 0.91, and the limits of agreement varied between 9.6 degrees and 37.8 degrees. The percentage of paired observations within 5 degrees, 10 degrees, and 15 degrees ranged from 17% to 60%, 33% to 93%, and 50% to 97%, respectively. CONCLUSIONS: Despite the use of a standardized protocol and a sophisticated measurement system, the interobserver reliability of neck mobility was variable in quality, with reliability being good in rotation in neutral position, flexion-extension, and lateral bending.

Variation in the cervical range of motion over time measured by the "flock of birds" electromagnetic tracking system.

STUDY DESIGN: Observational longitudinal study. OBJECTIVE: To establish the normal variation over time for active and passive cervical range of motion (ROM) measured with the Flock of Birds electromagnetic tracking system (FOB). SUMMARY OF BACKGROUND DATA: Data about normal variation of cervical ROM over time are scarce but important for the interpretation of study results. METHODS: Forty-eight subjects without a manifest dysfunction in neck and shoulder region (asymptomatic group) and 58 subjects with a dysfunction in the neck and shoulder region (symptomatic group) participated in this study. Cervical active and passive ROM was assessed in three different sessions 6 weeks apart. The following movements were measured: flexion-extension, lateral bending, and axial rotation in neutral, flexed, and extended position. RESULTS: A wide range of variation of active and passive cervical ROM was found at the 6- and 12-week measurement in the asymptomatic group as well as in the symptomatic group. Highest variation was found during passive ROM testing as compared with active ROM testing. The symptomatic group showed larger variation than the asymptomatic group. CONCLUSIONS: Cervical range of motion varies considerably over time. This variation should be taken into account when results of therapeutic trials with respect to cervical ROM are interpreted.