Jan C. Winters

Manipulative Therapy in Addition to Usual Medical Care for Patients with Shoulder Dysfunction and Pain: A Randomized, Controlled Trial

Context Shoulder pain in the absence of trauma, fracture, rupture, or dislocation can lead to substantial functional limitations and can be a difficult condition to treat. Contribution In this randomized, controlled trial, patients with shoulder pain and shoulder girdle dysfunction assigned to receive manipulative therapy in addition to usual general practitioner care had more rapid improvement in symptoms and fewer shoulder symptoms at 12 weeks than patients assigned to usual care alone. Implications Manipulative therapy appears to be an effective treatment option for patients with shoulder pain and shoulder girdle dysfunction that are not due to trauma, fracture, rupture, or dislocation. The Editors Shoulder disorders are a widely recognized medical, social, and economic problem (1). They are characterized by functional disability due to pain in the shoulder at rest or during movement or by functional disability due to restricted range of motion. The annual incidence of shoulder symptoms in Dutch general medical practices is estimated to be 10 to 25 per 1000 enrolled patients (2-4). In the Netherlands, shoulder disorders are treated according to the Guidelines for Shoulder Complaints of the Dutch College of General Practitioners (5, 6). Initial treatment during the first 2 weeks includes informing patients about the nature and course of shoulder symptoms and advising them on how to use the affected shoulder during daily living. Patients can also be prescribed analgesics or nonsteroidal anti-inflammatory drugs if necessary. If this initial treatment is not effective, up to 3 corticosteroid injections (in the subacromial space or glenohumeral joint) can be given. Referral for physiotherapy is considered only for patients whose symptoms persist for 6 weeks or more. This treatment regimen, according to the guidelines, provides short-term benefit for many patients but cannot prevent the often unfavorable long-term course of the symptoms. Indeed, only 50% of all new episodes of shoulder disorders resolve within 6 months, while at 12 months more than 40% of all patients are still disabled during work and leisure time (4, 7). Pain or dysfunction of the cervicothoracic spine and the adjacent ribs (also called the shoulder girdle) often accompanies shoulder symptoms (8). A considerable proportion of patients with shoulder symptoms (approximately 20%) but no shoulder joint disorders may be found to have dysfunction of the shoulder girdle on further physical examination (9). Moreover, dysfunction of the shoulder girdle triples the risk for shoulder complications (10) and also predicts poor outcome of shoulder disorders (10-12). In clinical practice, dysfunction of the shoulder girdle can be treated with manipulative therapy, which aims to restore normal function. Winters and colleagues (13) found that manipulative therapy accelerated recovery and improved symptoms compared with physiotherapy in a relatively small subgroup of patients with both shoulder symptoms and shoulder girdle dysfunction. These effects were not sustained on long-term follow-up, possibly because of high attrition rates (14). Evidence showing that manipulative therapy for the shoulder girdle effectively treats shoulder symptoms is scarce; Winters and colleagues have performed the only randomized trial (13, 14) to date. Our objective was to study the effectiveness of manipulative therapy for the shoulder girdle in addition to usual medical care by a general practitioner. The study design has been described elsewhere (15), and the trial was designed and reported accord ing to the Consolidated Standards of Reporting Trials (CONSORT) statement (16). We report the effects of the use of additional manipulative therapy for the shoulder girdle to treat shoulder symptoms. Methods Participants Potential eligible participants with shoulder symptoms (pain and dysfunction) were recruited in 50 general practices in Groningen, the Netherlands. General practitioners started initial treatment (usual medical care) at presentation, assessed eligibility criteria, and told the conducting researcher about each eligible patient. The general practitioner used a standardized eligibility checklist and a physical examination as recommended by the Dutch College of General Practitioners (5, 6). A baseline assessment at the research center was scheduled within 2 weeks of presentation. Shoulder symptoms were defined as pain between the neck and the elbow at rest or during movement of the upper arm (Figure 1). Pain radiating to the neck region or to the lower part of the arm was not used as an exclusion criterion. The physical examination established the presence of both shoulder symptoms and dysfunction of the cervicothoracic spine and the adjacent ribs with accompanying pain or restricted movement. Eligible patients were 18 years of age or older and had had no consultation or treatment for shoulder symptoms in the past 3 months. No limits were placed on duration of symptoms before the first consultation. Figure 1. Location of shoulder symptoms. Reasons for exclusion were acute severe trauma, such as fractures, ruptures, or dislocation in the shoulder region; previous orthopedic surgery; clear treatment preference deviating from the study protocol; contraindications to manipulative therapy (for example, hypermobility, instability, or severe arthrosis of the cervicothoracic spine); signs of cervical nerve root compression; presence of specific rheumatic disorders; presence of dementia or other severe psychiatric, emotional, or behavioral disorders; shoulder disorders due to general internal disease of thoracic and abdominal organs; and inability to complete Dutch-language written questionnaires. Eligibility and exclusion criteria were verified before randomization by using a structured medical history and physical assessment. Randomization Patients were evenly allocated to receive manipulative therapy plus usual medical care or usual medical care alone. An independent statistician not involved in recruitment of patients generated a random list that was stratified for general practitioner by permutation of randomized blocks, with a block size of 6. After eligibility was verified, written informed consent was obtained. A researcher opened preprepared numbered, opaque sealed envelopes containing the treatment allocation codes and made appointments with manual therapists when applicable. Interventions Usual Medical Care All patients received usual medical care from their general practitioners. Usual medical care was similar to that outlined by the Dutch College of General Practitioners (5, 6) and included information, advice, and therapy. During the first 2 weeks, patients were given information about the nature and course of shoulder symptoms, along with advice on daily use of the affected shoulder. Patients were prescribed oral analgesics or nonsteroidal anti-inflammatory drugs if necessary. The Dutch College of General Practitioners recommends 2 weeks of treatment with paracetamol, 4 times daily (maximum dosage, 4000 mg/d), or nonsteroidal anti-inflammatory drugs such as ibuprofen, 3 times daily (maximum dosage, 2400 mg/d); diclofenac, 3 times daily (maximum dosage, 150 mg/d); or naproxen, twice daily (maximum dosage, 1000 mg/d) (5, 6). If patients did improve, drug treatment could be extended for another 2 weeks. If this approach was ineffective, up to 3 corticosteroid injections could be given in either the subacromial space or the glenohumeral joint. For injections in either location, physicians used triamcinolone acetonide, 40 mg suspended in a 1-mL vehicle, if necessary, combined with lidocaine, 10 mg suspended in a 5- to 10-mL vehicle. If improvement remained insufficient 2 weeks after injections were given, injections could be repeated. Further corticosteroid treatment was not considered appropriate if patients did not improve after the second series of injections. For symptoms persisting at least 6 weeks, physiotherapy consisting of shoulder exercises, massage, and physical applications was considered. Other referrals during the intervention and follow-up periods (for example, to a rheumatology consultant or orthopedic surgeon) were discouraged but were documented if they occurred. Manipulative Therapy According to the International Federation of Orthopedic Manipulative Therapists, orthopedic manipulative (manual) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other symptoms of neuro-musculo-articular dysfunction in the spine and extremities. Our approach to manipulative therapy focused on manual manipulation and mobilization techniques used in western Europe, North America, and Australia, including those described by Cyriax (17), Greenman (18), and Lewit (19). In our trial, manipulative therapy included specific manipulations (low-amplitude, high-velocity thrust techniques) and specific mobilizations (high-amplitude, low-velocity thrust techniques) to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine and upper thoracic spine and adjacent ribs. The manual therapist chose the applied techniques on the basis of the location of the dysfunction and the therapists technique preferences. Within the boundaries of the protocol, treatment could be reassessed and adapted to the patients condition. A maximum of 6 treatment sessions could be given over a 12-week period. Eight experienced physiotherapists who were members of the Dutch Association of Manual Therapy and registered by the Royal Dutch Society for Physical Therapy (a member of the International Federation of Orthopedic Manipulative Therapists) provided the manual therapy. To minimize variations in manipulative therapy, therapists received a special training session to familiarize them with the protocols mobilization and manipulation techniques for treatment of the cervico

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.

Guideline for diagnosis and treatment of subacromial pain syndrome: A multidisciplinary review by the Dutch Orthopaedic Association

Treatment of “subacromial impingement syndrome” of the shoulder has changed drastically in the past decade. The anatomical explanation as “impingement” of the rotator cuff is not sufficient to cover the pathology. “Subacromial pain syndrome”, SAPS, describes the condition better. A working group formed from a number of Dutch specialist societies, joined by the Dutch Orthopedic Association, has produced a guideline based on the available scientific evidence. This resulted in a new outlook for the treatment of subacromial pain syndrome. The important conclusions and advice from this work are as follows: (1) The diagnosis SAPS can only be made using a combination of clinical tests. (2) SAPS should preferably be treated non-operatively. (3) Acute pain should be treated with analgetics if necessary. (4) Subacromial injection with corticosteroids is indicated for persistent or recurrent symptoms. (5) Diagnostic imaging is useful after 6 weeks of symptoms. Ultrasound examination is the recommended imaging, to exclude a rotator cuff rupture. (6) Occupational interventions are useful when complaints persist for longer than 6 weeks. (7) Exercise therapy should be specific and should be of low intensity and high frequency, combining eccentric training, attention to relaxation and posture, and treatment of myofascial trigger points (including stretching of the muscles) may be considered. (8) Strict immobilization and mobilization techniques are not recommended. (9) Tendinosis calcarea can be treated by shockwave (ESWT) or needling under ultrasound guidance (barbotage). (10) Rehabilitation in a specialized unit can be considered in chronic, treatment resistant SAPS, with pain perpetuating behavior. (11) There is no convincing evidence that surgical treatment for SAPS is more effective than conservature management. (12) There is no indication for the surgical treatment of asymptomatic rotator cuff tears.

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

BackgroundDe Quervains 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 Quervains tenosynovitis provided by general practitioners was assessed.MethodsParticipants with de Quervains 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).Results11 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.ConclusionOne 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 Quervains 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 registrationCurrent Controlled Trials ISRCTN53171398

Corticosteroid injections effective for trigger finger in adults in general practice: a double-blinded randomised placebo controlled trial

OBJECTIVE To study efficacy and safety of corticosteroid injections for trigger finger (flexor tenosynovitis) in adults in general practice. METHODS Adult patients presenting with trigger finger were recruited by 21 participating general practitioners. In this randomised placebo controlled double-blinded trial, patients were injected locally with one or two injections of 1 ml triamcinolonacetonide (TCA) or 0.9% NaCl. Outcomes regarding immediate treatment response, severity of symptoms, functional disability, patient satisfaction and side effects were measured 1 week after intervention and during the 12 months thereafter. RESULTS A total of 50 patients were included. Short-term outcomes for the TCA and NaCl group, respectively, were: proportion of patients with satisfactory immediate treatment response 16/25 and 5/25 (p<0.001), patients with reduction in the frequency of triggering 13/24 and 6/22 (p = 0.053), mean difference in severity of pain 4.2 and 0.9 (p<0.001), patients perceiving improvement 22/25 and 9/25 (p<0.001) and difference in Arthritis Impact Measurement Scale 2 (AIMS-2) score 4.02 and 0.06 (p = 0.001). Long-term effects could only be assessed by analysing the cohort of participants who received TCA (as allocated treatment or escape treatment), due to a high proportion of non-responders in the NaCl group. The short-term beneficial effects were maintained during the follow-up phase of 12 months. Patients were satisfied with corticosteroid injection therapy and there were only a few minor side effects. CONCLUSIONS Local injection with TCA is effective and safe for treating trigger finger as compared to placebo injection. The effects of steroid injections last up to 12 months.

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

BackgroundCarpal 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.MethodsIn 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.ResultsThe 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).ConclusionsCorticosteroid 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 registrationCurrent Controlled Trials ISRCTN53171398

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 Cohens 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.

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.

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.

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

BackgroundSubacromial 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/DesignThe 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.DiscussionThe 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.