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Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A... Background: Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost- effectiveness. Methods/Design: This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor monthly. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Page 1 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Participant measures of perceived change will be compared between groups by calculating the relative risks and their 95% confidence intervals at each time point using log binomial regression. Discussion: Results from this trial will contribute to the evidence regarding the effectiveness of a physiotherapy program for the management of CRCP. Trial registration: NIH Clinical Trials Registry # NCT00415441 on history and clinical findings. Investigative procedures Background Shoulder disorders are a common cause of musculoskele- such as x-ray, ultrasound or magnetic resonance imaging tal morbidity in the community [1,2], affecting 15–30% may be used to demonstrate CRCP or to exclude other less of adults at any one time [3] and having their peak preva- common shoulder pathologies. lence in the mid-to-older age groups [4]. Since moving the shoulder allows placement of the hand, compromised It is thought that shoulder impingement is involved in the shoulder function impacts substantially on tasks essential initiation and/or perpetuation of CRCP. This occurs when to daily living such as dressing, eating, personal hygiene the greater tuberosity impinges against the coracoacro- and work [5]. Shoulder pain often impairs the ability to mial arch in shoulder elevation causing mechanical irrita- sleep, thus affecting mood and concentration. Hence tion of local structures [15]. While there is speculation as shoulder disorders can lead to considerable disability, to whether the pathology seen with CRCP is primary or reductions in health-related quality of life, absenteeism secondary to impingement, a number of factors can play from work and substantial utilization of health care a role in CRCP [15,16]. In particular, if the rotator cuff resources [5-7]. muscles do not function in a co-ordinated manner with each other as well as with the principal muscles that move Shoulder disorders are a common reason for seeking med- the humerus and scapula, then inadequate stabilisation of ical care – in Australia, they account for 1.2% of all general the humeral head may occur during shoulder elevation practice encounters, being third only to back (3.8%) and [17,18]. Poor shoulder, cervical and thoracic posture as neck complaints as musculoskeletal reasons for primary well as tight structures can also contribute to dysfunc- care consultations [8]. They also account for up to 10% of tional movement patterns [19,20] and ultimately chronic all referrals to physiotherapists [9]. Shoulder disorders are pathology and pain. often recalcitrant with persisting pain and disability from 12 [10] to 18 months [11] in up to 50% of cases. Chronic Physiotherapy is often the first line of management for shoulder conditions may require surgical intervention in CRCP [21]. In a survey of approximately 800 primary care 15–28% of individuals [12]. Thus, they are a relevant medical practitioners, 79% stated that their usual treat- health problem for clinicians, funding providers and ment of a patient with CRCP would be referral to a phys- health-care policy makers. iotherapist [21]. Physiotherapy aims to reduce pain and disability by improving the biomechanics and movement Although there is controversy as to exact definitions for patterns of the shoulder complex rather than by treating different shoulder diagnostic categories, a large propor- the pathology per se. In clinical practice, patients with tion of shoulder problems can be classified under the term CRCP receive a combination of physiotherapy interven- 'chronic rotator cuff pathology' (CRCP). The term (or its tions in order to effectively address the modifiable factors variants such as impingement syndrome) includes a spec- contributing to pain and dysfunction. trum of pathologies (tears, inflammation, tendonitis, degeneration) involving contractile and other local struc- While physiotherapy is commonly prescribed for CRCP, tures around the shoulder joint [13,14] giving rise to sim- at present there is little conclusive evidence to support or ilar signs and symptoms. Pain is the main feature, refute its effectiveness, and no formal evaluation of its particularly on overhead movement, at night, and when cost-effectiveness. In a Cochrane review, 11 trials were lying on the affected side. Examination may reveal a pain- identified that evaluated physiotherapy for CRCP [22]. ful arc during shoulder elevation, pain on resisted shoul- No firm conclusions were able to be drawn given the var- der abduction, external rotation or internal rotation, and iable methodological quality of the trials and the fact that a positive impingement test (ref). Restricted shoulder many tested a single physiotherapy modality with few range may be present but is mostly related to pain rather testing combined modalities despite this being the most than stiffness per se [15]. Unlike other shoulder condi- common way in which shoulder disorders are treated in tions, such as adhesive capsulitis, global shoulder passive practice. Furthermore, eight of the 11 (72%) CRCP trials restriction is not a feature. Diagnosis is traditionally based evaluated electrotherapy modalities which are generally Page 2 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 not recommended by expert clinicians as the most appro- inflammatory medication in past two weeks; (x) inability priate physiotherapy modality to treat CRCP. From the tri- to understand written and spoken English. als in CRCP or in mixed shoulder disorders that were included in the review, there was some evidence to pro- A diagnosis of CRCP by a medical doctor supported by a pose that exercise may be effective, with additional benefit plain x-ray of the shoulder will be necessary for potential from mobilisation [23-26]. Recent trials identified since inclusion. All volunteers will then be required to undergo this Cochrane review still fail to clarify the effectiveness of a physical examination with a physiotherapist to screen physiotherapy for CRCP given differences in the treatment for signs and symptoms, and to exclude shoulder pain program, comparison group and outcomes [27-30]. The that is not due to rotator cuff origin (eg, neural or cervical need for further clinical trials in this area is supported by referral, adhesive capsulitis). Participants with bilateral the conclusions and recommendations of other recent CRCP symptoms will be asked to indicate which shoulder systematic reviews [31-33]. is the most symptomatic. This shoulder will be treated. Those with equally symptomatic shoulders will receive Therefore, the aim of this trial is to determine whether a treatment for the shoulder of the dominant limb. 10-week multimodal physiotherapy program reflective of current physiotherapy practice improves pain, disability The Royal Melbourne Hospital Human Research Ethics and health-related quality of life and is more cost-effective Committee approved the study (Project #2001.115) and than placebo in individuals with CRCP. all participants will provide written informed consent. Randomisation and allocation Methods/Design Design Following a physical screening examination, volunteers This will be a randomised placebo controlled trial with who meet the inclusion criteria will be accepted as partic- blinded participants and outcome assessors (Figure 1). ipants and undergo baseline assessment at the University The trial comprises a 10-week intervention and a 12-week of Melbourne. Following baseline assessment, partici- follow-up (Figure 1). Participants will be assessed imme- pants will be stratified by treatment site and randomly diately before treatment (baseline), immediately after assigned in permuted block of six and eight to either phys- treatment (final) and at 22 weeks (follow-up) post ran- iotherapy or placebo treatment groups. The randomisa- domisation. The assessments will be performed by the tion sequence will be generated using a computer- same assessor who will be blind to group allocation. generated table of random numbers by the study biostat- istician (AF). Allocations will be sealed in opaque and Participants consecutively numbered envelopes kept in a locked loca- A community sample will be recruited in Melbourne, Aus- tion. These will be opened in sequence by an independent tralia through orthopaedic and rheumatology outpatient administrator not involved in eligibility assessment, out- clinics, community-based practices and general practi- come assessment or treatment. Allocation will be revealed tioners as well as by advertising in print and radio media. to the treating physiotherapist by fax before the partici- Inclusion criteria will be: (i) aged over 18 years; (ii) shoul- pant presents for treatment. der pain for greater than 3 months; (iii) pain severity on movement rated at least 4/10 on an 11 point numeric rat- Interventions Ten musculoskeletal physiotherapists located around ing scale; (iv) pain on active abduction or external rota- tion and; (v) positive shoulder impingement quick test metropolitan Melbourne will implement both interven- [34]. Exclusion criteria will be: (i) resting shoulder pain of tions. All treatments will be individual sessions lasting greater than 7/10 in severity; (ii) reason to suspect a com- 30–45 minutes, twice weekly for the first 2 weeks, once a plete rotator cuff tear eg. substantial shoulder weakness, a week for the next 4 weeks, then once a fortnight in the last positive drop-arm sign or a high riding humerus observed 4 weeks (a total of 10 treatments). Participants will be on plain xray; (iii) prior shoulder surgery; (iv) radiological requested to refrain from seeking other forms of treatment evidence of shoulder osteoarthritis, shoulder joint calcifi- during the trial. However, due to ethical considerations, cation or prior fracture; (v) systemic pathology including analgesia will be permitted. Use of medications and other inflammatory joint disease or neoplastic disorders; (vi) therapies will be recorded in a logbook. more than 50% restriction of passive range of motion in two or more planes; (vii) shoulder pain referred from ver- The treatments will be standardized and the therapists tebral structures diagnosed via spinal clearing tests [35]; will be trained to deliver both treatments prior to the (viii) symptoms of complex regional pain syndrome; (iix) study. A comprehensive treatment manual will be pro- active intervention in last 3 months including corticoster- duced and the importance of following the protocol oid/hydrodilatation injection or physiotherapy; (ix) anti- emphasised. For the physiotherapy treatment, it is consid- ered important to allow the therapists to adjust the inten- Page 3 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Phone Screening Ineligible Fail inclusion criteria Meet exclusion criteria Physical Screening Ineligible Fail inclusion criteria Meet exclusion criteria 0 weeks Consent, baseline assessment and randomisation Placebo Physiotherapy intervention intervention 10 weeks Final assessment Home exercise No treatment 22 weeks Follow-up assessment Tr Figure 1 ial profile Trial profile. Page 4 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 sity of the standardised treatment techniques to match the and with the shoulder in 45 degrees abduction and 90 participants' capabilities. Thus the number of repetitions degrees abduction respectively [35]. Grade IV oscillations of the exercises can be reduced. Deletion of techniques (into 50% resistance) will be maintained for 30 seconds will be permitted if participants find them too painful. At and repeated four times. the end of each treatment session for each participant, the physiotherapist will complete a checklist to ensure com- Scapular retraining pliance with the standard approach. The aim of scapular retraining is to improve control of scapular movement, particularly to avoid excessive eleva- All participants will be requested not to seek other forms tion and protraction, so as to optimise the functional of treatment during the study but use of analgesia will be position of the shoulder. The therapist will passively guide permitted and recorded in a log-book. the participant from a neutral shoulder girdle posture to an adducted, depressed position, then to an upwardly Physiotherapy intervention group rotated, elevated position. The participant will then per- A standardized treatment protocol has been devised (SC) form the movement actively for several repetitions fol- based on the literature and on the results of a formal writ- lowed by a 10 second hold in the adducted, depressed ten survey we conducted involving 10 musculoskeletal posture. This will be repeated 5 times. Postural taping will physiotherapists around Australia, considered by the pro- also be worn full time for the first two weeks. The therapist fession to be experts in treating shoulder conditions. will firstly apply a protective skin barrier followed by non- These physiotherapists were asked to indicate which of a rigid, hypoallergenic tape to provide skin protection, and series of interventions they would generally use at three then rigid strapping tape for postural adjustments. The stages of a 10-week program when managing a typical shoulder taping technique aims to encourage a retracted, patient with CRCP. The results showed that the most com- depressed scapular posture and thoracic extension. monly employed modalities were scapular retraining (100%), rotator cuff exercises (100%), spinal (83%) and Spinal joint mobilisations shoulder joint mobilisation (50%), soft tissue massage Mobilisation techniques will be performed to improve (66%) and taping (50%). Less emphasis is placed on elec- range of cervical and thoracic motion, particularly tho- trotherapy modalities (33%) with few using these, partic- racic extension. They will include unilateral lower cervical ularly past the first three weeks of treatment (Coburn et al spine (C5-7) and central upper-mid thoracic spine (T1-8) unpublished data). posteroanterior mobilisation techniques with the partici- pant in prone lying [35]. The therapist will use a Grade IV The aims of the resultant physiotherapy intervention are force at each level, on both sides for the cervical spine and to i) decrease pain; ii) improve functional range of shoul- centrally for the thoracic spine. The duration of this treat- der motion; iii) improve scapular control; iv) strengthen ment will be four minutes for each technique. scapular stabilisers and rotator cuff muscles; v) improve Home exercises posture and thoracic extension range of motion; vi) regain normal shoulder biomechanics. The treatment has five These are predominantly designed to increase rotator cuff components comprising soft tissue massage, passive and scapular muscle strength (Table 2). Most exercises mobilisation of the glenohumeral joint, scapula retrain- require the participant to incorporate their scapular ing, spinal mobilisation, and home exercises (Table 1). retraining with strengthening of the rotator cuff muscles. Cognitive behavioural strategies will also be incorporated Some exercises reinforce and facilitate correct posture. including education, goal-setting, motivation and posi- These exercises will be taught and performed during each tive reinforcement. treatment session and exercise progressions will be intro- duced regularly throughout the course of the treatment Soft tissue massage program. Resistance for specific exercises will be provided Deep massage of the soft tissue structures around the by hand weights or elastic theraband. Participants will be shoulder joint will be performed for six minutes in two asked to perform the exercises daily, except during the first positions. The posterior joint capsule and scapular shoul- week of treatment where exercises will be completed twice der musculature will be massaged in sidelying while the per day. Compliance will be monitored via a weekly log anterior shoulder structures including the supraspinatus, book completed by the participant. During the follow-up, long head of biceps and pectoralis minor tendons will be the physiotherapy group will be requested to continue massaged in supine. daily home exercises. Glenohumeral joint mobilisation Placebo group Anteroposterior and inferior glenohumeral joint mobili- As for many procedural interventions, it is difficult to sations will be performed with the participant in supine design a placebo treatment that fully mimics a physiother- Page 5 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Table 1: Components of the physiotherapy intervention Treatment component Dosage Soft tissue massage 6 mins each position Anterior and posterior shoulder tissues performed in supine and sidelying respectively Glenohumeral joint mobilisation 4 × 30 seconds each position Anteroposterior and inferior joint glides in supine with shoulder at 45° and 90° abduction respectively Thoracic spine mobilisation (T1-8) Grade IV on each level – 4 mins in total Performed in prone using a central posteroanterior technique Cervical spine mobilisation (C5-7) Grade IV on each level – 4 mins in total Performed in prone using unilateral posteroanterior technique on both sides Scapular retraining Weeks 1 and 2 only In sidelying, therapist passively moves shoulder through range from 15 reps × 5 reps with 10 sec holds elevation/protraction to retraction/depression then assisted by participant then independently. Isometric holds in retraction/ depression Postural taping Continuous (day and night) for two weeks Taping of the shoulders and scapula to encourage scapular retraction Re-applied after one week by the therapist and depression and thoracic extension Exercises Home program: Supervised and performed as home program Twice daily in first two weeks Once a day thereafter apy program. However, our aim is to control for the effect sor. At trial completion, participants will nominate which of regular contact with a therapist, the belief that treat- group they believed they have been allocated to. The data ment will assist CRCP and the therapeutic environment. manager and statistician will be unaware of treatment Participants in the placebo group will receive the same allocation until completion of analyses. number and length of visits as those in the physiotherapy group but will receive only sham ultrasound and light Outcome assessment application of a non-therapeutic gel. Participants in the Demographic information will be collected including age, placebo group will receive no instruction in exercise tech- sex, duration of symptoms, previous investigations and niques and no manual therapy. We have used an identical treatment, history of medical conditions, and medication placebo protocol in completed clinical trials of physio- use. Expectation of a beneficial treatment effect will be therapy for patellofemoral pain syndrome [36], knee oste- scored on an ordinal scale from 1 to 5 with higher scores oarthritis [37] and shoulder adhesive capsulitis [38]. In indicating higher expectations. these trials, between 68% to 83% of participants in the placebo group thought they had received 'real' physiother- A number of outcome measures will be collected for this apy or were unsure. Blinding index was 0.49 (bootstrap study (Table 3). A combined shoulder pain and disability 95% CI 0.40 to 0.56), interpreted as moderate success of index (SPADI) will be used to measure changes in shoul- blinding in one study [38]. The placebo participants will der pain and function at final and follow-up time points. not receive any intervention or complete any home exer- This is a self-administered, shoulder-specific index con- cises during the 12 week follow-up period. sisting of 13 items divided into two subscales: pain (five items) and disability (eight items) [39]. Responses to each Blinding item are recorded on a 11 point Likert scale where 0 = "no To maintain blinding, the plain language statement and pain" or "no difficulty" and 10 = "worst imaginable pain" consent procedures will inform participants that they or "so difficult it required help" for the pain and disability have an equal chance of receiving real or placebo physio- items respectively. The SPADI score is calculated by sum- therapy but will not disclose details of the actual treat- ming then averaging the two subscales to give a score out ments. A blinded examiner will perform all outcome of 100 (higher score more pain/disability). It has accepta- assessments. Participant blinding will be optimised by ble test-retest reliability, construct validity and responsive- using a realistic placebo intervention and by ensuring par- ness [39-41]. We have confirmed the clinimetric ticipants do not attend for treatments or assessments con- properties of this index and found it to be more respon- currently. Participants will also be requested to refrain sive than other shoulder-specific questionnaires (effect from discussing their treatment with the outcome asses- sizes 1.01–1.69) (Buchbinder et al unpublished data). Page 6 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Table 2: Description of specific exercises Name Description Dosage Weeks performed Scapular setting Sitting, isometric hold of scapula in retracted and depressed 5 sec hold × 5 reps Week 1 then position maintained in all exercises Self-resisted isometric ER Standing sideways to wall. Upper arm squeezing a towel roll 5 sec hold × 5 reps Weeks 1&2 against body, elbow bent with forearm pushing into wall Active ER Sitting with shoulder in 45° Abd resting elbow and forearm 10 reps × 2 Week 1&2 on table in IR. Taking shoulder into ER Shoulder shrugs Standing with arms slightly abducted and actively elevating 10 reps × 2 handweight Week 1&2 scapula then lowering slowly Pectoralis minor stretch Supine with arms in 45° Abd and elbows bent to 90°. 5 reps with 10 sec hold × 2 Weeks 2–6 Shoulders rotate into ER to stretch muscle Wall push up Standing arms length from wall, hands at shoulder height 5 reps × 2 Weeks 2–10 and shoulders in 45° Abd. Body lowered to wall and then pushed away Chin tuck Standing with head and back against a wall. Chin tucked in 5 reps × 10 sec holds Week 2 toward neck Resisted external rotation Sidelying with affected shoulder uppermost, elbow bent to 10 reps × 2 using hand Week 2 90° and holding weight in hand. Weight lifted up toward weight ceiling with upper arm against body Thoracic extension over towel Supine on a firm surface with arms by side and lying on 1–3 mins hold Weeks 3–6 towel roll placed horizontally on floor at level of maximum thoracic curve Resisted scapular setting – elbow Standing, arm by side and elbow bent holding theraband 10 reps × 2 using Weeks 3–6 extension with shoulder neutral attached in front at shoulder height. Elbow straightened and theraband slowly flexed whilst keeping scapula in set position Resisted external rotation Standing, elbow bent to 90° and forearm along stomach and 10 reps × 2 using Weeks 3&4 holding onto theraband at waist height. Keeping elbow in to theraband side, pulling against theraband to perform ER Resisted internal rotation Standing, elbow bent to 90° and shoulder in ER and holding 10 reps × 2 using Weeks 3&4 onto theraband at waist height. Keeping elbow in by side, theraband pulling against theraband to perform IR Resisted horizontal row Standing, both arms outstretched holding onto theraband 10 reps × 2 using Weeks 3–10 attached at waist height. Both arms pulled back toward theraband trunk with elbows flexed Resisted external rotation in Sitting with shoulder supported in 90° Abd on table and 10 reps × 2 using hand Weeks 5&6 supported 90° Abd forearm resting on table holding a weight in hand. Weight weight lifted toward ceiling keeping elbow on table Resisted internal rotation in Sitting with shoulder supported in 90° Abd on table and 10 reps × 2 using Weeks 5&6 supported 90° Abd forearm resting on table holding theraband attached behind. theraband Hand taken to table to perform IR Corner stretch Standing with one hand on each corner wall at shoulder 5 reps × 10 sec holds Weeks 5–10 height and elbows bent. Leaning in toward corner to stretch anterior shoulder and thoracic spine Resisted scapular setting – elbow Standing with hands at chest height, elbows bent and 10 reps × 2 Weeks 7–10 flexion holding onto theraband which is then stretched apart by trying to straighten both elbows Resisted external rotation in ER performed in standing with shoulder unsupported in 45° 10 reps × 2 Weeks 7–10 unsupported Abd scapular plane, elbow bent and holding theraband attached in front Resisted internal rotation in IR performed in standing with shoulder unsupported in 45° 10 reps × 2 Weeks 7–10 unsupported Abd scapular plane, elbow bent and holding theraband attached behind ER = external rotation; IR = internal rotation; Abd = abduction Average pain, worst pain and pain on three self-selected Participant perceived global rating of change overall and activities (over the past week) will be measured by sepa- in pain, strength, and stiffness (since commencement) rate 11-point numeric rating scales [12] numbered in 1 will be recorded on separate 5 point Likert scales (1-much cm intervals. The amount of weakness, stiffness and inter- worse, 2-slightly worse, 3-no change, 4-slightly better, 5- ference with activities of daily living (over the past week) much better). Measuring participant perceived improve- will be measured similarly. ment using a rating of change scale has been shown to be Page 7 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Table 3: Outcome measures Primary Outcomes Measurement Shoulder pain and disability index (SPADI) 13 items scored on an 11 point Likert scale Average pain over past week 11 point horizontal numeric rating scale (end descriptors of 0 = no pain and 10 = worst pain possible) Participant perceived global rating of change overall Ordinal scale (1-much worse, 2-slightly worse, 3-no change, 4-slightly better, 5-much better) Secondary Outcomes Worst pain, and pain on 3 self selected activities in past week 11 point horizontal numeric rating scale (end descriptors of 0 = no pain and 10 = worst pain possible) Amount of stiffness, weakness, and interference to activities of daily 11 point horizontal numeric rating scale living in past week Participant perceived global rating of change in pain, strength, and Ordinal scale (1-much worse, 2-slightly worse, 3-no change, 4-slightly stiffness better, 5-much better) Health-related quality of life • SF-36 • Assessment of Quality of Life index (AQol) Isometric muscle strength of shoulder abduction, internal rotation and Hand held dynamometer external rotation Other measures Compliance • Number of therapy visits • Physiotherapy group: Completion of home exercises via log-book Adverse effects Log-book and open probe questionning a clinically relevant and stable concept for interpreting supine with the shoulder in 90 degrees of abduction and truly meaningful improvements from the individual per- the elbow flexed to 90 degrees. The dynamometer will be spective [42]. A successful outcome will be defined a pri- positioned on the lateral surface of the distal humerus, ori as 'much better' on the rating scale. proximal to the lateral epicondyle. Measurements of exter- nal and internal rotation will be performed in sitting with Health-related quality of life will be measured using the the arm by the side against a folded towel, the elbow Medical Outcomes Study 36-item short form (SF-36) (8 flexed to 90 degrees and the forearm in midprone. The subscales scaled from 0–100 where a higher score repre- dynamometer will be positioned on the distal forearm. sents better health) [43]. This the most widely used One warm up trial followed by three maximal contrac- generic measure of health related quality of life and per- tions will be performed and the median reading taken. We mits comparison of the impact of disease and treatment previously measured 12 people with CRCP on two occa- across studies and populations. The clinimetric properties sions three days apart. Intraclass correlation coefficient of the SF-36 have been well established on samples from (ICC 2,3) values were 0.95 for abduction, 0.96 for internal diverse populations [43,44]. We will also use the Assess- rotation and 0.93 for external rotation indicating that test ment of Quality of Life (AQoL) instrument. The AQoL retest reliability was excellent. comprises 15 items on ordinal scales with four levels per item covering five dimensions (illness, independent liv- A number of other measures will be obtained (Table 3). ing, social relationships, physical senses and psychologi- Participant compliance will be obtained by recording the cal wellbeing). It produces a single utility index that number of physiotherapy sessions attended (out of a max- ranges from -0.04 (worst possible health-related quality of imum number of 10). Those in the physiotherapy group life) to 1.00 (full health-related quality of life). The AQoL will complete a daily log-book to record the number of has strong psychometric properties [45,46]. The AQoL can home exercise sessions completed. Adverse events and the also be converted into a utility index to calculate quality use of co-intervention will be recorded in a log-book and adjusted life years (QALY). by open-probe questioning by the assessor at trial comple- tion. Log-books will be posted back to the assessor on a Isometric shoulder strength for shoulder abduction, inter- monthly basis and checked for completion. At the final nal and external rotation will be measured using the and followup measurement time points, study partici- Nicholas Manual Muscle tester (Lafayette, USA). For pants will be asked to indicate which treatment they shoulder abduction, participants will be positioned in Page 8 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 believe they have received and reasons for that choice to measurements, a robust variance and unstructured work- assess the success of blinding. ing correlation [49]. Constancy of the difference between groups over time will be assessed by fitting models which Information on direct health care costs, direct non-health include a term for the interaction between treatment and care costs and production losses over the 22 weeks will be time. Sensitivity analyses include repetition of analyses collected by a logbook posted back to the assessor on a with calculation of bootstrap standard errors, and identi- monthly basis and checked for completion. Direct health fication of influential individuals by sequentially omit- care costs will include costs of physiotherapy attendance ting each participant and refitting the model. (assumed zero in the placebo group), additional health provider visits, tests, prescription and over the counter Participant measures of perceived improvement following medication, professional home care and hospitalisation. physiotherapy or placebo treatments will be compared by These will be valued using published prices for medical calculating the relative risks and their 95% confidence costs. Direct non-health care resources will include use of intervals at each time point using log binomial regression paid and unpaid help, lost time and travel, and number of [50]. Repeated measures relative risk calculations will be lost days at work. performed using generalised estimating equations with a logarithmic link function, robust variance and unstruc- Sample size tured correlation [49]. As above, models including a term Sample size was calculated based upon the ability to for the interaction between treatment and time will be fit detect a 10-point difference in improvement in SPADI to assess the constancy of the difference between groups score, previously reported to indicate a clinically impor- over time. tant improvement (or worsening) of shoulder function [41]. Applying power calculations appropriate for analysis The primary economic evaluation will take the form of a of covariance (adjusting for baseline SPADI score), to cost effectiveness study with a range of outcome measures detect a difference in 10 week SPADI of 10 units assuming including the incremental cost per extra person with a a common between-participant standard deviation of 27 clinically significant improvement in pain, per extra per- and a baseline to 10 week correlation in SPADI scores of son perceived to be recovered, and per extra quality 0.45 (from our pilot study), 91 participants per group will adjusted life years (using the AQoL over 22 weeks). A be required to achieve 80% power at a two-sided 5% sig- social perspective on costs will be taken that includes nificance level. Including the 10 week and further 22 week resource use incurred both by health services and by the follow-ups in a repeated measures analysis increases the participant irrespective of the source of payment. The power to 85% assuming a conservative correlation of 0.8 inclusion of time/productivity gains is controversial and between all post-baseline measurements and a uniform the cost effectiveness ratios will be calculated with and physiotherapy effect. We will allow for a 10% loss to fol- without these indirect costs. All health care costs will be low-up and aim to recruit 100 participants per group. included, however to reduce the impact of extreme values, if inpatient hospital costs are unrelated to CRCP they will Data analysis be excluded. Standard methods of economic evaluation All analyses will be conducted on an intention-to-treat alongside a clinical trial [51] will be used to evaluate the principle using all randomized participants. Missing data differences in resource use and health outcomes over 12 will be replaced by the last score carried forward. Demo- months between groups. The statistical analysis of costs graphic characteristics and baseline data will be summa- data will be similar to outcome data although adjust- rised by descriptive statistics. An index will be computed ments for overdispersion may be necessary. Confidence to assess the success of blinding [47]. This index takes the intervals for incremental cost effectiveness will be calcu- value one for complete blinding and zero for complete lated directly using non-parametric bootstrapping [52]. In lack of blinding. addition we will calculate a cost effectiveness acceptability curve based for a range of hypothetical money values of For outcomes measured using an essentially continuous outcomes [53]. This will be done using individual cost scale, differences in mean change from baseline to each and outcome data over the 22 weeks or, if adjustments for time point will be compared between groups using linear imbalance at baseline are necessary, using regression anal- regression modelling adjusting for baseline levels of the ysis [54]. Hypothetical money values will be taken from outcome measure. Model assumptions will be checked by the decision making literature but the trial will also ask standard diagnostic plots [48]. For analysis across all time patients in each arm of the trial their willingness to pay for points simultaneously, accounting for repeated measure- the treatment prior to and after treatment. This will not ments, we will estimate the differences between groups only provide money values for the calculation of net ben- using generalised estimating equation models for the efits but also provide evidence on the influence of health post-baseline measurements with adjustment for baseline experience on the value of health outcome to patients. Page 9 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 ensure that any effects of the personality of each therapist Discussion This study uses a double-blind randomised controlled and the treatment environment are equally distributed. trial design to investigate whether a multimodal physio- therapy program has greater effects on pain, disability and It is anticipated that all participants will be recruited by health-related quality of life and is more cost-effective the middle of 2007 with data acquisition completed six than placebo in people with CRCP. The benefits of physi- months later. The results from this trial will contribute to otherapy for this patient group have not been well estab- evidence based recommendations for the effectiveness of lished in the literature and there is no information on its a physiotherapy program in the management of CRCP. cost effectiveness. Competing interests At present there is no gold standard diagnostic test for The author(s) declare that they have no competing inter- CRCP. Our criteria for inclusion into the study are based ests. on clinical assessment performed by a medical doctor and a physiotherapist together with a shoulder xray to assist in Authors' contributions KB, SC and RB conceived and designed the trial protocol. differential diagnosis. While imaging techniques such as magnetic resonance imaging or ultrasound may further KB, RB, SG, SC, AH and AF procured the project funding. improve diagnostic accuracy particularly if performed by SC and SG designed the physiotherapy intervention. AH a single experienced operator [55], these still lack sensitiv- designed the economic analysis. AF designed the statisti- ity for certain pathologic features [56,57] and are costly. cal analysis. EW is the research assistant and blinded We wished to reflect the population that present to pri- assessor. KB drafted the manuscript and RB, EW, SC, SG, mary care for assessment and treatment and who in many AH and AF contributed to the manuscript. All authors cases will not have these investigative procedures per- read and approved the final manuscript. formed. Acknowledgements This work is funded by the National Health and Medical Research Council Physiotherapy generally encompasses a multimodal (Project Grant #299840). Pilot funds were provided by ANZ Trustees, approach to treatment. Therapists utilise a variety of tech- Department of Physiotherapy and Victor Hurley Grant Royal Melbourne niques such as mobilisation, soft tissue massage, taping, Hospital, and the School of Physiotherapy, University of Melbourne. None exercise prescription and education. As there is no 'gold of the funders have any role in the study other than to provide funding. R standard' physiotherapy for CRCP, we chose to use a Buchbinder is funded by an Australian National Health and Medical standardised program rather than employ a pragmatic Research Council Practitioner Fellowship. We wish to acknowledge the design whereby therapists chose the program based on project physiotherapists Richard Bohen, Tanya Farmer, Marie-Louise their own clinical reasoning and experience. This was Francken, Nigel Friend, Jean Leaf, Arthur Lee, Stephen Maloney, Christine Roberts, Paul Visentini and Simon Wilson. done to ensure a consistent approach and to allow repli- cation of the program tested. 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Paterson C, Dieppe P: Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. Bmj 2005, 330(7501):1202-1205. Pre-publication history The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2474/8/86/prepub Publish with Bio Med Central and every scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime." 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Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

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Springer Journals
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Copyright © 2007 by Bennell et al; licensee BioMed Central Ltd.
Subject
Medicine & Public Health; Orthopedics; Rehabilitation; Rheumatology; Sports Medicine; Internal Medicine; Epidemiology
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1471-2474
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10.1186/1471-2474-8-86
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17761004
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Abstract

Background: Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost- effectiveness. Methods/Design: This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor monthly. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Page 1 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Participant measures of perceived change will be compared between groups by calculating the relative risks and their 95% confidence intervals at each time point using log binomial regression. Discussion: Results from this trial will contribute to the evidence regarding the effectiveness of a physiotherapy program for the management of CRCP. Trial registration: NIH Clinical Trials Registry # NCT00415441 on history and clinical findings. Investigative procedures Background Shoulder disorders are a common cause of musculoskele- such as x-ray, ultrasound or magnetic resonance imaging tal morbidity in the community [1,2], affecting 15–30% may be used to demonstrate CRCP or to exclude other less of adults at any one time [3] and having their peak preva- common shoulder pathologies. lence in the mid-to-older age groups [4]. Since moving the shoulder allows placement of the hand, compromised It is thought that shoulder impingement is involved in the shoulder function impacts substantially on tasks essential initiation and/or perpetuation of CRCP. This occurs when to daily living such as dressing, eating, personal hygiene the greater tuberosity impinges against the coracoacro- and work [5]. Shoulder pain often impairs the ability to mial arch in shoulder elevation causing mechanical irrita- sleep, thus affecting mood and concentration. Hence tion of local structures [15]. While there is speculation as shoulder disorders can lead to considerable disability, to whether the pathology seen with CRCP is primary or reductions in health-related quality of life, absenteeism secondary to impingement, a number of factors can play from work and substantial utilization of health care a role in CRCP [15,16]. In particular, if the rotator cuff resources [5-7]. muscles do not function in a co-ordinated manner with each other as well as with the principal muscles that move Shoulder disorders are a common reason for seeking med- the humerus and scapula, then inadequate stabilisation of ical care – in Australia, they account for 1.2% of all general the humeral head may occur during shoulder elevation practice encounters, being third only to back (3.8%) and [17,18]. Poor shoulder, cervical and thoracic posture as neck complaints as musculoskeletal reasons for primary well as tight structures can also contribute to dysfunc- care consultations [8]. They also account for up to 10% of tional movement patterns [19,20] and ultimately chronic all referrals to physiotherapists [9]. Shoulder disorders are pathology and pain. often recalcitrant with persisting pain and disability from 12 [10] to 18 months [11] in up to 50% of cases. Chronic Physiotherapy is often the first line of management for shoulder conditions may require surgical intervention in CRCP [21]. In a survey of approximately 800 primary care 15–28% of individuals [12]. Thus, they are a relevant medical practitioners, 79% stated that their usual treat- health problem for clinicians, funding providers and ment of a patient with CRCP would be referral to a phys- health-care policy makers. iotherapist [21]. Physiotherapy aims to reduce pain and disability by improving the biomechanics and movement Although there is controversy as to exact definitions for patterns of the shoulder complex rather than by treating different shoulder diagnostic categories, a large propor- the pathology per se. In clinical practice, patients with tion of shoulder problems can be classified under the term CRCP receive a combination of physiotherapy interven- 'chronic rotator cuff pathology' (CRCP). The term (or its tions in order to effectively address the modifiable factors variants such as impingement syndrome) includes a spec- contributing to pain and dysfunction. trum of pathologies (tears, inflammation, tendonitis, degeneration) involving contractile and other local struc- While physiotherapy is commonly prescribed for CRCP, tures around the shoulder joint [13,14] giving rise to sim- at present there is little conclusive evidence to support or ilar signs and symptoms. Pain is the main feature, refute its effectiveness, and no formal evaluation of its particularly on overhead movement, at night, and when cost-effectiveness. In a Cochrane review, 11 trials were lying on the affected side. Examination may reveal a pain- identified that evaluated physiotherapy for CRCP [22]. ful arc during shoulder elevation, pain on resisted shoul- No firm conclusions were able to be drawn given the var- der abduction, external rotation or internal rotation, and iable methodological quality of the trials and the fact that a positive impingement test (ref). Restricted shoulder many tested a single physiotherapy modality with few range may be present but is mostly related to pain rather testing combined modalities despite this being the most than stiffness per se [15]. Unlike other shoulder condi- common way in which shoulder disorders are treated in tions, such as adhesive capsulitis, global shoulder passive practice. Furthermore, eight of the 11 (72%) CRCP trials restriction is not a feature. Diagnosis is traditionally based evaluated electrotherapy modalities which are generally Page 2 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 not recommended by expert clinicians as the most appro- inflammatory medication in past two weeks; (x) inability priate physiotherapy modality to treat CRCP. From the tri- to understand written and spoken English. als in CRCP or in mixed shoulder disorders that were included in the review, there was some evidence to pro- A diagnosis of CRCP by a medical doctor supported by a pose that exercise may be effective, with additional benefit plain x-ray of the shoulder will be necessary for potential from mobilisation [23-26]. Recent trials identified since inclusion. All volunteers will then be required to undergo this Cochrane review still fail to clarify the effectiveness of a physical examination with a physiotherapist to screen physiotherapy for CRCP given differences in the treatment for signs and symptoms, and to exclude shoulder pain program, comparison group and outcomes [27-30]. The that is not due to rotator cuff origin (eg, neural or cervical need for further clinical trials in this area is supported by referral, adhesive capsulitis). Participants with bilateral the conclusions and recommendations of other recent CRCP symptoms will be asked to indicate which shoulder systematic reviews [31-33]. is the most symptomatic. This shoulder will be treated. Those with equally symptomatic shoulders will receive Therefore, the aim of this trial is to determine whether a treatment for the shoulder of the dominant limb. 10-week multimodal physiotherapy program reflective of current physiotherapy practice improves pain, disability The Royal Melbourne Hospital Human Research Ethics and health-related quality of life and is more cost-effective Committee approved the study (Project #2001.115) and than placebo in individuals with CRCP. all participants will provide written informed consent. Randomisation and allocation Methods/Design Design Following a physical screening examination, volunteers This will be a randomised placebo controlled trial with who meet the inclusion criteria will be accepted as partic- blinded participants and outcome assessors (Figure 1). ipants and undergo baseline assessment at the University The trial comprises a 10-week intervention and a 12-week of Melbourne. Following baseline assessment, partici- follow-up (Figure 1). Participants will be assessed imme- pants will be stratified by treatment site and randomly diately before treatment (baseline), immediately after assigned in permuted block of six and eight to either phys- treatment (final) and at 22 weeks (follow-up) post ran- iotherapy or placebo treatment groups. The randomisa- domisation. The assessments will be performed by the tion sequence will be generated using a computer- same assessor who will be blind to group allocation. generated table of random numbers by the study biostat- istician (AF). Allocations will be sealed in opaque and Participants consecutively numbered envelopes kept in a locked loca- A community sample will be recruited in Melbourne, Aus- tion. These will be opened in sequence by an independent tralia through orthopaedic and rheumatology outpatient administrator not involved in eligibility assessment, out- clinics, community-based practices and general practi- come assessment or treatment. Allocation will be revealed tioners as well as by advertising in print and radio media. to the treating physiotherapist by fax before the partici- Inclusion criteria will be: (i) aged over 18 years; (ii) shoul- pant presents for treatment. der pain for greater than 3 months; (iii) pain severity on movement rated at least 4/10 on an 11 point numeric rat- Interventions Ten musculoskeletal physiotherapists located around ing scale; (iv) pain on active abduction or external rota- tion and; (v) positive shoulder impingement quick test metropolitan Melbourne will implement both interven- [34]. Exclusion criteria will be: (i) resting shoulder pain of tions. All treatments will be individual sessions lasting greater than 7/10 in severity; (ii) reason to suspect a com- 30–45 minutes, twice weekly for the first 2 weeks, once a plete rotator cuff tear eg. substantial shoulder weakness, a week for the next 4 weeks, then once a fortnight in the last positive drop-arm sign or a high riding humerus observed 4 weeks (a total of 10 treatments). Participants will be on plain xray; (iii) prior shoulder surgery; (iv) radiological requested to refrain from seeking other forms of treatment evidence of shoulder osteoarthritis, shoulder joint calcifi- during the trial. However, due to ethical considerations, cation or prior fracture; (v) systemic pathology including analgesia will be permitted. Use of medications and other inflammatory joint disease or neoplastic disorders; (vi) therapies will be recorded in a logbook. more than 50% restriction of passive range of motion in two or more planes; (vii) shoulder pain referred from ver- The treatments will be standardized and the therapists tebral structures diagnosed via spinal clearing tests [35]; will be trained to deliver both treatments prior to the (viii) symptoms of complex regional pain syndrome; (iix) study. A comprehensive treatment manual will be pro- active intervention in last 3 months including corticoster- duced and the importance of following the protocol oid/hydrodilatation injection or physiotherapy; (ix) anti- emphasised. For the physiotherapy treatment, it is consid- ered important to allow the therapists to adjust the inten- Page 3 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Phone Screening Ineligible Fail inclusion criteria Meet exclusion criteria Physical Screening Ineligible Fail inclusion criteria Meet exclusion criteria 0 weeks Consent, baseline assessment and randomisation Placebo Physiotherapy intervention intervention 10 weeks Final assessment Home exercise No treatment 22 weeks Follow-up assessment Tr Figure 1 ial profile Trial profile. Page 4 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 sity of the standardised treatment techniques to match the and with the shoulder in 45 degrees abduction and 90 participants' capabilities. Thus the number of repetitions degrees abduction respectively [35]. Grade IV oscillations of the exercises can be reduced. Deletion of techniques (into 50% resistance) will be maintained for 30 seconds will be permitted if participants find them too painful. At and repeated four times. the end of each treatment session for each participant, the physiotherapist will complete a checklist to ensure com- Scapular retraining pliance with the standard approach. The aim of scapular retraining is to improve control of scapular movement, particularly to avoid excessive eleva- All participants will be requested not to seek other forms tion and protraction, so as to optimise the functional of treatment during the study but use of analgesia will be position of the shoulder. The therapist will passively guide permitted and recorded in a log-book. the participant from a neutral shoulder girdle posture to an adducted, depressed position, then to an upwardly Physiotherapy intervention group rotated, elevated position. The participant will then per- A standardized treatment protocol has been devised (SC) form the movement actively for several repetitions fol- based on the literature and on the results of a formal writ- lowed by a 10 second hold in the adducted, depressed ten survey we conducted involving 10 musculoskeletal posture. This will be repeated 5 times. Postural taping will physiotherapists around Australia, considered by the pro- also be worn full time for the first two weeks. The therapist fession to be experts in treating shoulder conditions. will firstly apply a protective skin barrier followed by non- These physiotherapists were asked to indicate which of a rigid, hypoallergenic tape to provide skin protection, and series of interventions they would generally use at three then rigid strapping tape for postural adjustments. The stages of a 10-week program when managing a typical shoulder taping technique aims to encourage a retracted, patient with CRCP. The results showed that the most com- depressed scapular posture and thoracic extension. monly employed modalities were scapular retraining (100%), rotator cuff exercises (100%), spinal (83%) and Spinal joint mobilisations shoulder joint mobilisation (50%), soft tissue massage Mobilisation techniques will be performed to improve (66%) and taping (50%). Less emphasis is placed on elec- range of cervical and thoracic motion, particularly tho- trotherapy modalities (33%) with few using these, partic- racic extension. They will include unilateral lower cervical ularly past the first three weeks of treatment (Coburn et al spine (C5-7) and central upper-mid thoracic spine (T1-8) unpublished data). posteroanterior mobilisation techniques with the partici- pant in prone lying [35]. The therapist will use a Grade IV The aims of the resultant physiotherapy intervention are force at each level, on both sides for the cervical spine and to i) decrease pain; ii) improve functional range of shoul- centrally for the thoracic spine. The duration of this treat- der motion; iii) improve scapular control; iv) strengthen ment will be four minutes for each technique. scapular stabilisers and rotator cuff muscles; v) improve Home exercises posture and thoracic extension range of motion; vi) regain normal shoulder biomechanics. The treatment has five These are predominantly designed to increase rotator cuff components comprising soft tissue massage, passive and scapular muscle strength (Table 2). Most exercises mobilisation of the glenohumeral joint, scapula retrain- require the participant to incorporate their scapular ing, spinal mobilisation, and home exercises (Table 1). retraining with strengthening of the rotator cuff muscles. Cognitive behavioural strategies will also be incorporated Some exercises reinforce and facilitate correct posture. including education, goal-setting, motivation and posi- These exercises will be taught and performed during each tive reinforcement. treatment session and exercise progressions will be intro- duced regularly throughout the course of the treatment Soft tissue massage program. Resistance for specific exercises will be provided Deep massage of the soft tissue structures around the by hand weights or elastic theraband. Participants will be shoulder joint will be performed for six minutes in two asked to perform the exercises daily, except during the first positions. The posterior joint capsule and scapular shoul- week of treatment where exercises will be completed twice der musculature will be massaged in sidelying while the per day. Compliance will be monitored via a weekly log anterior shoulder structures including the supraspinatus, book completed by the participant. During the follow-up, long head of biceps and pectoralis minor tendons will be the physiotherapy group will be requested to continue massaged in supine. daily home exercises. Glenohumeral joint mobilisation Placebo group Anteroposterior and inferior glenohumeral joint mobili- As for many procedural interventions, it is difficult to sations will be performed with the participant in supine design a placebo treatment that fully mimics a physiother- Page 5 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Table 1: Components of the physiotherapy intervention Treatment component Dosage Soft tissue massage 6 mins each position Anterior and posterior shoulder tissues performed in supine and sidelying respectively Glenohumeral joint mobilisation 4 × 30 seconds each position Anteroposterior and inferior joint glides in supine with shoulder at 45° and 90° abduction respectively Thoracic spine mobilisation (T1-8) Grade IV on each level – 4 mins in total Performed in prone using a central posteroanterior technique Cervical spine mobilisation (C5-7) Grade IV on each level – 4 mins in total Performed in prone using unilateral posteroanterior technique on both sides Scapular retraining Weeks 1 and 2 only In sidelying, therapist passively moves shoulder through range from 15 reps × 5 reps with 10 sec holds elevation/protraction to retraction/depression then assisted by participant then independently. Isometric holds in retraction/ depression Postural taping Continuous (day and night) for two weeks Taping of the shoulders and scapula to encourage scapular retraction Re-applied after one week by the therapist and depression and thoracic extension Exercises Home program: Supervised and performed as home program Twice daily in first two weeks Once a day thereafter apy program. However, our aim is to control for the effect sor. At trial completion, participants will nominate which of regular contact with a therapist, the belief that treat- group they believed they have been allocated to. The data ment will assist CRCP and the therapeutic environment. manager and statistician will be unaware of treatment Participants in the placebo group will receive the same allocation until completion of analyses. number and length of visits as those in the physiotherapy group but will receive only sham ultrasound and light Outcome assessment application of a non-therapeutic gel. Participants in the Demographic information will be collected including age, placebo group will receive no instruction in exercise tech- sex, duration of symptoms, previous investigations and niques and no manual therapy. We have used an identical treatment, history of medical conditions, and medication placebo protocol in completed clinical trials of physio- use. Expectation of a beneficial treatment effect will be therapy for patellofemoral pain syndrome [36], knee oste- scored on an ordinal scale from 1 to 5 with higher scores oarthritis [37] and shoulder adhesive capsulitis [38]. In indicating higher expectations. these trials, between 68% to 83% of participants in the placebo group thought they had received 'real' physiother- A number of outcome measures will be collected for this apy or were unsure. Blinding index was 0.49 (bootstrap study (Table 3). A combined shoulder pain and disability 95% CI 0.40 to 0.56), interpreted as moderate success of index (SPADI) will be used to measure changes in shoul- blinding in one study [38]. The placebo participants will der pain and function at final and follow-up time points. not receive any intervention or complete any home exer- This is a self-administered, shoulder-specific index con- cises during the 12 week follow-up period. sisting of 13 items divided into two subscales: pain (five items) and disability (eight items) [39]. Responses to each Blinding item are recorded on a 11 point Likert scale where 0 = "no To maintain blinding, the plain language statement and pain" or "no difficulty" and 10 = "worst imaginable pain" consent procedures will inform participants that they or "so difficult it required help" for the pain and disability have an equal chance of receiving real or placebo physio- items respectively. The SPADI score is calculated by sum- therapy but will not disclose details of the actual treat- ming then averaging the two subscales to give a score out ments. A blinded examiner will perform all outcome of 100 (higher score more pain/disability). It has accepta- assessments. Participant blinding will be optimised by ble test-retest reliability, construct validity and responsive- using a realistic placebo intervention and by ensuring par- ness [39-41]. We have confirmed the clinimetric ticipants do not attend for treatments or assessments con- properties of this index and found it to be more respon- currently. Participants will also be requested to refrain sive than other shoulder-specific questionnaires (effect from discussing their treatment with the outcome asses- sizes 1.01–1.69) (Buchbinder et al unpublished data). Page 6 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Table 2: Description of specific exercises Name Description Dosage Weeks performed Scapular setting Sitting, isometric hold of scapula in retracted and depressed 5 sec hold × 5 reps Week 1 then position maintained in all exercises Self-resisted isometric ER Standing sideways to wall. Upper arm squeezing a towel roll 5 sec hold × 5 reps Weeks 1&2 against body, elbow bent with forearm pushing into wall Active ER Sitting with shoulder in 45° Abd resting elbow and forearm 10 reps × 2 Week 1&2 on table in IR. Taking shoulder into ER Shoulder shrugs Standing with arms slightly abducted and actively elevating 10 reps × 2 handweight Week 1&2 scapula then lowering slowly Pectoralis minor stretch Supine with arms in 45° Abd and elbows bent to 90°. 5 reps with 10 sec hold × 2 Weeks 2–6 Shoulders rotate into ER to stretch muscle Wall push up Standing arms length from wall, hands at shoulder height 5 reps × 2 Weeks 2–10 and shoulders in 45° Abd. Body lowered to wall and then pushed away Chin tuck Standing with head and back against a wall. Chin tucked in 5 reps × 10 sec holds Week 2 toward neck Resisted external rotation Sidelying with affected shoulder uppermost, elbow bent to 10 reps × 2 using hand Week 2 90° and holding weight in hand. Weight lifted up toward weight ceiling with upper arm against body Thoracic extension over towel Supine on a firm surface with arms by side and lying on 1–3 mins hold Weeks 3–6 towel roll placed horizontally on floor at level of maximum thoracic curve Resisted scapular setting – elbow Standing, arm by side and elbow bent holding theraband 10 reps × 2 using Weeks 3–6 extension with shoulder neutral attached in front at shoulder height. Elbow straightened and theraband slowly flexed whilst keeping scapula in set position Resisted external rotation Standing, elbow bent to 90° and forearm along stomach and 10 reps × 2 using Weeks 3&4 holding onto theraband at waist height. Keeping elbow in to theraband side, pulling against theraband to perform ER Resisted internal rotation Standing, elbow bent to 90° and shoulder in ER and holding 10 reps × 2 using Weeks 3&4 onto theraband at waist height. Keeping elbow in by side, theraband pulling against theraband to perform IR Resisted horizontal row Standing, both arms outstretched holding onto theraband 10 reps × 2 using Weeks 3–10 attached at waist height. Both arms pulled back toward theraband trunk with elbows flexed Resisted external rotation in Sitting with shoulder supported in 90° Abd on table and 10 reps × 2 using hand Weeks 5&6 supported 90° Abd forearm resting on table holding a weight in hand. Weight weight lifted toward ceiling keeping elbow on table Resisted internal rotation in Sitting with shoulder supported in 90° Abd on table and 10 reps × 2 using Weeks 5&6 supported 90° Abd forearm resting on table holding theraband attached behind. theraband Hand taken to table to perform IR Corner stretch Standing with one hand on each corner wall at shoulder 5 reps × 10 sec holds Weeks 5–10 height and elbows bent. Leaning in toward corner to stretch anterior shoulder and thoracic spine Resisted scapular setting – elbow Standing with hands at chest height, elbows bent and 10 reps × 2 Weeks 7–10 flexion holding onto theraband which is then stretched apart by trying to straighten both elbows Resisted external rotation in ER performed in standing with shoulder unsupported in 45° 10 reps × 2 Weeks 7–10 unsupported Abd scapular plane, elbow bent and holding theraband attached in front Resisted internal rotation in IR performed in standing with shoulder unsupported in 45° 10 reps × 2 Weeks 7–10 unsupported Abd scapular plane, elbow bent and holding theraband attached behind ER = external rotation; IR = internal rotation; Abd = abduction Average pain, worst pain and pain on three self-selected Participant perceived global rating of change overall and activities (over the past week) will be measured by sepa- in pain, strength, and stiffness (since commencement) rate 11-point numeric rating scales [12] numbered in 1 will be recorded on separate 5 point Likert scales (1-much cm intervals. The amount of weakness, stiffness and inter- worse, 2-slightly worse, 3-no change, 4-slightly better, 5- ference with activities of daily living (over the past week) much better). Measuring participant perceived improve- will be measured similarly. ment using a rating of change scale has been shown to be Page 7 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 Table 3: Outcome measures Primary Outcomes Measurement Shoulder pain and disability index (SPADI) 13 items scored on an 11 point Likert scale Average pain over past week 11 point horizontal numeric rating scale (end descriptors of 0 = no pain and 10 = worst pain possible) Participant perceived global rating of change overall Ordinal scale (1-much worse, 2-slightly worse, 3-no change, 4-slightly better, 5-much better) Secondary Outcomes Worst pain, and pain on 3 self selected activities in past week 11 point horizontal numeric rating scale (end descriptors of 0 = no pain and 10 = worst pain possible) Amount of stiffness, weakness, and interference to activities of daily 11 point horizontal numeric rating scale living in past week Participant perceived global rating of change in pain, strength, and Ordinal scale (1-much worse, 2-slightly worse, 3-no change, 4-slightly stiffness better, 5-much better) Health-related quality of life • SF-36 • Assessment of Quality of Life index (AQol) Isometric muscle strength of shoulder abduction, internal rotation and Hand held dynamometer external rotation Other measures Compliance • Number of therapy visits • Physiotherapy group: Completion of home exercises via log-book Adverse effects Log-book and open probe questionning a clinically relevant and stable concept for interpreting supine with the shoulder in 90 degrees of abduction and truly meaningful improvements from the individual per- the elbow flexed to 90 degrees. The dynamometer will be spective [42]. A successful outcome will be defined a pri- positioned on the lateral surface of the distal humerus, ori as 'much better' on the rating scale. proximal to the lateral epicondyle. Measurements of exter- nal and internal rotation will be performed in sitting with Health-related quality of life will be measured using the the arm by the side against a folded towel, the elbow Medical Outcomes Study 36-item short form (SF-36) (8 flexed to 90 degrees and the forearm in midprone. The subscales scaled from 0–100 where a higher score repre- dynamometer will be positioned on the distal forearm. sents better health) [43]. This the most widely used One warm up trial followed by three maximal contrac- generic measure of health related quality of life and per- tions will be performed and the median reading taken. We mits comparison of the impact of disease and treatment previously measured 12 people with CRCP on two occa- across studies and populations. The clinimetric properties sions three days apart. Intraclass correlation coefficient of the SF-36 have been well established on samples from (ICC 2,3) values were 0.95 for abduction, 0.96 for internal diverse populations [43,44]. We will also use the Assess- rotation and 0.93 for external rotation indicating that test ment of Quality of Life (AQoL) instrument. The AQoL retest reliability was excellent. comprises 15 items on ordinal scales with four levels per item covering five dimensions (illness, independent liv- A number of other measures will be obtained (Table 3). ing, social relationships, physical senses and psychologi- Participant compliance will be obtained by recording the cal wellbeing). It produces a single utility index that number of physiotherapy sessions attended (out of a max- ranges from -0.04 (worst possible health-related quality of imum number of 10). Those in the physiotherapy group life) to 1.00 (full health-related quality of life). The AQoL will complete a daily log-book to record the number of has strong psychometric properties [45,46]. The AQoL can home exercise sessions completed. Adverse events and the also be converted into a utility index to calculate quality use of co-intervention will be recorded in a log-book and adjusted life years (QALY). by open-probe questioning by the assessor at trial comple- tion. Log-books will be posted back to the assessor on a Isometric shoulder strength for shoulder abduction, inter- monthly basis and checked for completion. At the final nal and external rotation will be measured using the and followup measurement time points, study partici- Nicholas Manual Muscle tester (Lafayette, USA). For pants will be asked to indicate which treatment they shoulder abduction, participants will be positioned in Page 8 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 believe they have received and reasons for that choice to measurements, a robust variance and unstructured work- assess the success of blinding. ing correlation [49]. Constancy of the difference between groups over time will be assessed by fitting models which Information on direct health care costs, direct non-health include a term for the interaction between treatment and care costs and production losses over the 22 weeks will be time. Sensitivity analyses include repetition of analyses collected by a logbook posted back to the assessor on a with calculation of bootstrap standard errors, and identi- monthly basis and checked for completion. Direct health fication of influential individuals by sequentially omit- care costs will include costs of physiotherapy attendance ting each participant and refitting the model. (assumed zero in the placebo group), additional health provider visits, tests, prescription and over the counter Participant measures of perceived improvement following medication, professional home care and hospitalisation. physiotherapy or placebo treatments will be compared by These will be valued using published prices for medical calculating the relative risks and their 95% confidence costs. Direct non-health care resources will include use of intervals at each time point using log binomial regression paid and unpaid help, lost time and travel, and number of [50]. Repeated measures relative risk calculations will be lost days at work. performed using generalised estimating equations with a logarithmic link function, robust variance and unstruc- Sample size tured correlation [49]. As above, models including a term Sample size was calculated based upon the ability to for the interaction between treatment and time will be fit detect a 10-point difference in improvement in SPADI to assess the constancy of the difference between groups score, previously reported to indicate a clinically impor- over time. tant improvement (or worsening) of shoulder function [41]. Applying power calculations appropriate for analysis The primary economic evaluation will take the form of a of covariance (adjusting for baseline SPADI score), to cost effectiveness study with a range of outcome measures detect a difference in 10 week SPADI of 10 units assuming including the incremental cost per extra person with a a common between-participant standard deviation of 27 clinically significant improvement in pain, per extra per- and a baseline to 10 week correlation in SPADI scores of son perceived to be recovered, and per extra quality 0.45 (from our pilot study), 91 participants per group will adjusted life years (using the AQoL over 22 weeks). A be required to achieve 80% power at a two-sided 5% sig- social perspective on costs will be taken that includes nificance level. Including the 10 week and further 22 week resource use incurred both by health services and by the follow-ups in a repeated measures analysis increases the participant irrespective of the source of payment. The power to 85% assuming a conservative correlation of 0.8 inclusion of time/productivity gains is controversial and between all post-baseline measurements and a uniform the cost effectiveness ratios will be calculated with and physiotherapy effect. We will allow for a 10% loss to fol- without these indirect costs. All health care costs will be low-up and aim to recruit 100 participants per group. included, however to reduce the impact of extreme values, if inpatient hospital costs are unrelated to CRCP they will Data analysis be excluded. Standard methods of economic evaluation All analyses will be conducted on an intention-to-treat alongside a clinical trial [51] will be used to evaluate the principle using all randomized participants. Missing data differences in resource use and health outcomes over 12 will be replaced by the last score carried forward. Demo- months between groups. The statistical analysis of costs graphic characteristics and baseline data will be summa- data will be similar to outcome data although adjust- rised by descriptive statistics. An index will be computed ments for overdispersion may be necessary. Confidence to assess the success of blinding [47]. This index takes the intervals for incremental cost effectiveness will be calcu- value one for complete blinding and zero for complete lated directly using non-parametric bootstrapping [52]. In lack of blinding. addition we will calculate a cost effectiveness acceptability curve based for a range of hypothetical money values of For outcomes measured using an essentially continuous outcomes [53]. This will be done using individual cost scale, differences in mean change from baseline to each and outcome data over the 22 weeks or, if adjustments for time point will be compared between groups using linear imbalance at baseline are necessary, using regression anal- regression modelling adjusting for baseline levels of the ysis [54]. Hypothetical money values will be taken from outcome measure. Model assumptions will be checked by the decision making literature but the trial will also ask standard diagnostic plots [48]. For analysis across all time patients in each arm of the trial their willingness to pay for points simultaneously, accounting for repeated measure- the treatment prior to and after treatment. This will not ments, we will estimate the differences between groups only provide money values for the calculation of net ben- using generalised estimating equation models for the efits but also provide evidence on the influence of health post-baseline measurements with adjustment for baseline experience on the value of health outcome to patients. Page 9 of 12 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:86 http://www.biomedcentral.com/1471-2474/8/86 ensure that any effects of the personality of each therapist Discussion This study uses a double-blind randomised controlled and the treatment environment are equally distributed. trial design to investigate whether a multimodal physio- therapy program has greater effects on pain, disability and It is anticipated that all participants will be recruited by health-related quality of life and is more cost-effective the middle of 2007 with data acquisition completed six than placebo in people with CRCP. The benefits of physi- months later. The results from this trial will contribute to otherapy for this patient group have not been well estab- evidence based recommendations for the effectiveness of lished in the literature and there is no information on its a physiotherapy program in the management of CRCP. cost effectiveness. Competing interests At present there is no gold standard diagnostic test for The author(s) declare that they have no competing inter- CRCP. Our criteria for inclusion into the study are based ests. on clinical assessment performed by a medical doctor and a physiotherapist together with a shoulder xray to assist in Authors' contributions KB, SC and RB conceived and designed the trial protocol. differential diagnosis. While imaging techniques such as magnetic resonance imaging or ultrasound may further KB, RB, SG, SC, AH and AF procured the project funding. improve diagnostic accuracy particularly if performed by SC and SG designed the physiotherapy intervention. AH a single experienced operator [55], these still lack sensitiv- designed the economic analysis. AF designed the statisti- ity for certain pathologic features [56,57] and are costly. cal analysis. EW is the research assistant and blinded We wished to reflect the population that present to pri- assessor. KB drafted the manuscript and RB, EW, SC, SG, mary care for assessment and treatment and who in many AH and AF contributed to the manuscript. All authors cases will not have these investigative procedures per- read and approved the final manuscript. formed. Acknowledgements This work is funded by the National Health and Medical Research Council Physiotherapy generally encompasses a multimodal (Project Grant #299840). Pilot funds were provided by ANZ Trustees, approach to treatment. Therapists utilise a variety of tech- Department of Physiotherapy and Victor Hurley Grant Royal Melbourne niques such as mobilisation, soft tissue massage, taping, Hospital, and the School of Physiotherapy, University of Melbourne. None exercise prescription and education. As there is no 'gold of the funders have any role in the study other than to provide funding. R standard' physiotherapy for CRCP, we chose to use a Buchbinder is funded by an Australian National Health and Medical standardised program rather than employ a pragmatic Research Council Practitioner Fellowship. We wish to acknowledge the design whereby therapists chose the program based on project physiotherapists Richard Bohen, Tanya Farmer, Marie-Louise their own clinical reasoning and experience. This was Francken, Nigel Friend, Jean Leaf, Arthur Lee, Stephen Maloney, Christine Roberts, Paul Visentini and Simon Wilson. done to ensure a consistent approach and to allow repli- cation of the program tested. 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Paterson C, Dieppe P: Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. Bmj 2005, 330(7501):1202-1205. Pre-publication history The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2474/8/86/prepub Publish with Bio Med Central and every scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime." Sir Paul Nurse, Cancer Research UK Your research papers will be: available free of charge to the entire biomedical community peer reviewed and published immediately upon acceptance cited in PubMed and archived on PubMed Central yours — you keep the copyright BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 12 of 12 (page number not for citation purposes)

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BMC Musculoskeletal DisordersSpringer Journals

Published: Aug 31, 2007

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