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Radial extracorporeal shockwave treatment compared withsupervised exercises in patients with subacromial painsyndrome: single blind randomised study Kaia Engebretsen, physiotherapist,1,2 Margreth Grotle, research leader,2,3 Erik Bautz-Holter, professor,1,2 LeivSandvik, professor,4 Niels G Juel, MD consultant,1,2 Ole Marius Ekeberg, Research fellow,1,2 Jens Ivar Brox, MDconsultant2,5 inflammatory drugs, and corticosteroid injections.
Objective To compare the effectiveness of radial Physiotherapy includes a variety of modalities such as extracorporeal shockwave treatment with that of electrotherapy, radial extracorporeal shockwave treat- supervised exercises in patients with shoulder pain.
ment, ultrasound treatment, laser treatment, manual Design Single blind randomised study.
therapy, supervised exercises, sling exercise treatment, Setting Outpatient clinic of physical medicine and and acupuncture.4-7 Some evidence exists for the effec- rehabilitation department in Oslo, Norway.
tiveness of corticosteroid injections, non-steroidal anti- Participants 104 patients with subacromial shoulder pain inflammatory drugs, and exercises for chronic shoulder pain.8-10 A recent systematic review con- Interventions Radial extracorporeal shockwave cluded that surgery and exercises are equally effective treatment: one session weekly for four to six weeks.
for rotator cuff disease.11 In studies of musculoskeletal Supervised exercises: two 45 minute sessions weekly for pain, women report pain that is more severe, more fre- quent, and of a longer duration than do men.12 13 Stra- Primary outcome measure Shoulder pain and disability tification by sex or adjustment for sex is therefore recommended in the analysis of data from trials.
Results A treatment effect in favour of supervised In a systematic review, Harniman et al found mod- exercises at 6, 12, and 18 weeks was found. The adjusted erate evidence that low energy radial extracorporeal treatment effect was −8.4 (95% confidence interval −16.5 shockwave treatment was not effective for non-calcify- to −0.6) points. A significantly higher proportion of ing rotator cuff tendinosis.6 Additional studies includ- patients in the group treated with supervised exercises ing patients with calcifying or non-calcifying tendinosis improved—odds ratio 3.2 (1.3 to 7.8). More patients in reported no treatment effect compared with sham or the shockwave treatment group had additional treatment control.14 15 Despite these findings, shockwave treat- between 12 and 18 weeks—odds ratio 5.5 (1.3 to 26.4).
ment is increasingly used for subacromial shoulder Conclusion Supervised exercises were more effective pain. To our knowledge, radial extracorporeal shock- than radial extracorporeal shockwave treatment for short wave treatment has not been compared with exercises term improvement in patients with subacromial shoulder in a clinical trial including patients with shoulder pain.
The purpose of this study was to compare the short Trial registration Clinical trials NCT00653081.
term effect of radial extracorporeal shockwave treat-ment and supervised exercises in patients with suba- The shoulder is the fourth most common site of mus-culoskeletal pain reported by patients to general prac- titioners and physiotherapists.1 Rotator cuff disease, impingement syndrome, and rotator cuff tendinosis The study was designed as a randomised single blind are terms used synonymously with subacromial clinical study. Participants were recruited by physi- shoulder pain. The exact source and mechanism of cians at the outpatient clinic of the Physical Medicine the pain is unknown.2 Histopathology studies show and Rehabilitation Department at Ullevaal University mainly degenerative changes in the rotator cuff ten- Hospital, Oslo, Norway, between July 2006 and dons, but other factors also contribute to the pain and Women and men aged between 18 and 70 years with Patients with subacromial shoulder pain are often subacromial shoulder pain lasting at least three months treated with physiotherapy, non-steroidal anti- were eligible for inclusion. The following diagnostic outcome measure was the shoulder pain and disability index (SPADI), a self report questionnaire for patientswith shoulder pain. The questionnaire consists of 13 Excluded (n=37): Not meeting inclusion criteria (n=31) questions divided into two domains: pain (five items) and disability (eight items).18 Answers are scored on visual analogue scales from 0 cm (best) to 11 cm (worst) and in accordance with the original scoringsystem.18 The total score ranges from 0 to 100 points,with a higher score indicating worse shoulder pain and disability.18 A version adapted to Norwegian language shockwave therapy (n=52)Received allocated intervention (n=51) and culture, translated and back translated by indepen- dent philologists, was used in this study.19 20 Intensity of pain during rest and activity in the pre- vious week was measured on a nine point Lickert-type scale, on which 1 indicates no pain and 9 indicates severe pain.21 Participants were asked two questions about spe- cific function of the shoulder: “Can you carry a shopping bag (5 kg)?” and “Can you take down something from a wall cupboard?” These questions were scored on a scale from 1 (easy) to 7 (impossible).21 Active range of motion was measured bilaterally with an accuracy of 5°.2122 Thepatients decided when the pain condition confined the Participants reported work status according to a vali- criteria were used: dysfunction or pain on abduction, dated questionnaire.23 A status of retired was recorded normal passive glenohumeral range of motion, pain on separately. They also recorded use of drug treatment, two of three isometric tests (abduction at 0° or 30°, including both daily and weekly treatments for pain, external or internal rotation), and a positive Ken- nedy-Hawkins sign.1 16 17 Park et al recommend thesecombined clinical tests for a clinical diagnosis of sub- acromial impingement syndrome (or rotator cuff ten- At six weeks the patients completed a postal question- dinosis) with a post-test probability of 95%.17 Patients naire, including the outcome measures, at home. The with rotator cuff rupture were included if they fulfilled 12 week and 18 week follow-ups were done at the hos- the above criteria. Exclusion criteria were bilateral pital. A blinded physiotherapist made the baseline and shoulder pain, previous surgery on the affected follow-up measurements. The patients were instructed shoulder, instability, clinical signs of a cervical syn- not to discuss their treatment with the blinded physio- drome, rheumatoid arthritis, clinical and radiological signs of glenohumeral or acromioclavicular arthritis,inability to understand Norwegian, serious psychiatric disorder, use of anticoagulant drugs (except low dose Both treatments were given at the Department of Phy- aspirin), pregnancy, previous experience of one of the sical Medicine and Rehabilitation. The supervised study interventions, or unwillingness to accept either exercise regimen, developed at Ullevaal University Hospital by Bøhmer in the 1980s,5 was provided bytwo physiotherapists experienced in its performance.
Patients attended two 45 minute sessions weekly for a The patients were referred to the investigator (KE, a maximum of 12 weeks. The first session included gath- physiotherapist), received oral and written informa- ering medical history and bilateral inspection of align- tion about the two treatments, and gave their informed ment, including the scapula and the glenohumeral consent before the baseline evaluation. A statistician joint. Movement pattern, the immediate co-contrac- not involved in data collection or analysis randomly tion, and timing of the scapula and the arm were allocated patients to treatment groups in blocks of observed during elevation to obtain a functional diag- four to six. Randomisation was stratified by sex. A per- nosis for individual guidance of treatment.5 24 The prin- son not involved in the treatments opened the sealed cipal focus was on relearning of normal movement envelopes and assigned appointments according to patterns, which could then be transferred to daily activities.5 The initial aim was to unload the stress onthe rotator cuff and subacromial structures.5 During this phase, a mirror for awareness of posture, manual The participants completed a comprehensive ques- techniques for loosening tense muscles, an elastic rub- tionnaire including questions on demographics, edu- ber band, and a sling fixed to the ceiling were used.5 24 cation, duration of pain, sick leave, emotional The patients received immediate feedback and correc- distress, and the outcome measures. The main tion (supervision) by the physiotherapist.
Table 1 | Baseline characteristics of participant according to treatment group. Values are time between the start of treatment and the 18 week numbers (percentages) unless stated otherwise The study was designed to detect a difference of 10 points in the shoulder pain and disability index score between groups with α value set at 0.05 (type I error) and β at 0.2 (type II error).26 After a pilot study, and in accordance with a previous study, the standard deviation was estimated to 20.26 The sample size was calculated as 48 in each group for a univariate analysis of covariance.27 This is a linear model using baseline measures of the primary outcome as a covariate. The ρ was set to 0.5.27 The study has three post-treatment registrations.
The main outcome variable (shoulder pain and disabil- ity index score) is considered to be a continuous variable.26 To evaluate the treatment effect (the mean difference between the groups at six, 12, and 18 weeks), Median (interquartile range) EQ5D index† we used the mixed model analysis (repeated measurements).28 This model includes the interaction between treatment and elapsed time, baseline values *0=worst imaginable health state; 100=best imaginable health state.
are adjusted, and we assume that data are missing at †Evaluates health status: five dimensions with three categories in each.
random.28 The distribution of future values for a parti-cipant who drops out at time t and one who remains in Once dysfunctional neuromuscular patterns were at time t is expected to be the same if they have the normalised, endurance exercises were performed same covariates and the same history of outcome with gradually increasing resistance. Principles of until time t.28 Model assumptions were checked by closed and open kinetic chain and plyometric exercises residual plots. We estimated the smallest detectable were incorporated in the next phase of training.5 24 real difference between two measurements on the Patients had an adjusted programme at home, which same person to be 19.6 points on the shoulder pain consisted of correction of alignment during daily living and disability index and used this as a cut-off point.19 and simple low loaded exercises with a thin elastic cord We calculated the number needed to treat (NNT) to provide assistance and resistance to the movement.
according to the method of Guyatt et al.29 We checked the secondary outcome measures for Radial extracorporeal shockwave treatment (Swiss normal distribution and found that parametric statis- Dolor Clast, EMS) was provided by a physiotherapist tics were appropriate.30 We used logistic regression experienced in its use. The treatment was administered with adjustment for baseline values to compare work once a week for four to six weeks; three to five tender status and drug treatment. We analysed data according points were treated each time. Points were identified to the intention to treat principle, in which the study through a patient oriented biofeedback process (inser- groups are compared in terms of the treatment to tion of supraspinatus tendon, dorsolaterally below the acromion, and a maximum of three trigger points inthe rotator cuff muscles).25 The frequency applied was 12-8 Hertz with from 2000 pulses per session, A total of 141 patients were eligible for inclusion, and with a pressure between 2.5 and 4.0 Bar, depending 104 were randomised for study intervention (fig 1).
on what the patient tolerated without local anaesthetic.
The groups were similar at baseline with regard to Radial extracorporeal shockwave treatment uses age, education, dominant arm affected, duration of low to medium energy shockwaves generated when a pain, sick leave, shoulder pain and disability index projectile is accelerated by compressed air and hits an score, and secondary outcome variables (tables 1, 2 applicator.7 These impulses are delivered into the tis- and 3). Seventeen (33%) patients in the radial extra- sue and spread as spherical “radial” waves (rather than corporeal shockwave group and 12 (23%) in the super- being focused). Patients were informed that the sug- vised exercise group were on sick leave because of gested mechanism for pain relief was hyperstimulation shoulder pain. Five patients in the radial extra- analgesia and increased neovascularisation that corporeal shockwave group and two in the supervised improves regeneration of tissue.625 Patients were exercise group claimed for disability pension.
advised to avoid activities that elicited pain.
Patients treated with radial extracorporeal shock- All the patients were asked not to have any addi- waves (n=52) received a median of five (interquartile tional treatment except analgesics (including anti- range 4-6) treatments. One patient had only one treat- inflammatory drugs) for their shoulder pain for the ment, and one patient had two treatments. Patients in Table 2 | Mean (SD) scores and differences in improvement with overall P values at 18 weeks, two out of 50 (64%) patients treated with supervised from mixed models linear (repeated measures analysis) exercises and 18/50 (36%) patients treated with radialextracorporeal shockwaves achieved a reduction in shoulder pain and disability index score exceedingthe smallest detectable difference of 19.6 points (odds group of supervised exercises and three (6%) in the radial extracorporeal shockwave group deteriorated after treatment. The number needed to treat was 3.2 (95% confidence interval 2.1 to 7.1).
At 18 weeks, results for pain, function, and active range of motion were not statistically significant (table 2).
More patients in the supervised exercise group returned to work (P=0.016) (table 3). Six patients in the supervised exercise group and one in the radial extracorporeal shockwave group used less drug treat- One patient in the supervised exercise group reported a considerable increase in pain and stiffness consistent with adhesive capsulitis and had only four treatments.
In the group treated with radial extracorporeal shock- waves, one patient dropped out after one treatment and one after two treatments because of the aggrava- tion of pain; one of them crossed over to the supervised We found a small but statistically significant difference in favour of supervised exercises over radial extra-corporeal shockwave treatment for the primary out- the supervised exercise group (n=51) received a med- come (shoulder pain and disability index) at six, 12, ian of 14 (11-16) treatments. One patient did not and 18 weeks in patients with subacromial shoulder receive supervised exercises because of depression, pain. The difference was consistent after adjustment and another had only four sessions because of an for education and duration of pain. In addition, more increase in pain and a suspected adhesive capsulitis.
patients from the radial extracorporeal shockwave One patient crossed over to the supervised exercise group (13 v 3) had additional treatment after group after one treatment with radial extracorporeal 12 weeks, suggesting that they were less satisfied. The shockwaves (fig 1). Fourteen patients did not return results for the differences in secondary outcomes were the questionnaire at six weeks. Two patients rando- in favour of exercises, but differences were not mised to supervised exercises did not attend follow-up at 12 and 18 weeks, and two patients in the radialextracorporeal shockwave group did not attend the 18 week follow-up (fig 1). Thirteen patients in the radial extracorporeal shockwave group and three patients inthe supervised exercise group received additional treatment (cortisone injections, chiropractic treatment, physical therapy/supervised exercises) between 12and 18 weeks (odds ratio 5.5, 95% confidence interval Radial extracorporeal shockwave treatment The treatment effect was in favour of supervised exer- cises at six, 12, and 18 weeks. At 18 weeks the treatment effect was −8.4 (95% confidence interval −16.5 to −0.6; Fig 2 | Mean shoulder pain and disability index scores with P=0.047) points (table 2, fig 2). The treatment effect 95% confidence intervals for supervised exercises and radial was consistent when adjusted for sex (P=0.049). Thirty Table 3 | Work status and drug treatment. Values are numbers (percentages) unless stated Supervised exercises and arthroscopic surgery are better Moderate evidence suggests that low energy radial extracorporeal shockwave treatment is not effective for non- Supervised exercises are better than radial extracorporeal shockwave treatment for short term improvement in *Old age pension not included (four in supervised exercise group and two in radial extracorporeal shockwavegroup at all follow-ups).
More patients treated with supervised exercises returned to †Includes drug treatments for pain, sleep problems, and depression.
significant except for change in work status after 18 weeks, which may indicate that supervised exercise Our results are in agreement with results from previous is a more comprehensive rehabilitation intervention.
trials recommending exercise therapy9-1131 and do notstrengthen the evidence for extracorporeal shockwave treatment.6 7 14 15 32 The difference in shoulder pain and The advantages of this study are the randomised disability index score of 8.4 points at the 18 week fol- design, stratification by sex, treatments provided by low-up was somewhat smaller than the difference (10 physiotherapists experienced in the use of the meth- points) the study was designed to detect. For inter- ods, high compliance, blinded observer, large number preting the effectiveness of the treatment, we must con- of patients attending follow-up, and intention to treat sider not only statistical significance but also whether the improvement (or deterioration) is relevant for the At least three possible limitations must be taken into patients or clinicians.33 By using the smallest detectable account when interpreting the results. Firstly, we did real difference for an individual patient of 19.6 points not include a placebo group and cannot exclude the as a cut-off point, we found that a larger proportion of possibility that the observed results reflect a placebo patients in the supervised exercise group than in the effect or the natural course of the condition. A previous radial extracorporeal shockwave treatment group trial reported that a supervised exercise regimen was improved.19 This suggests that more patients receiving superior to placebo, so we found it difficult to justify the inclusion of a placebo group.21 On the other hand, two improvement.19 34 The number needed to treat to ben- trials found no difference between sham and extra- efit from supervised exercises was three, which is con- corporeal shockwave treatment.7 14 We did not include sidered clinically important.29 However, the estimate a placebo radial extracorporeal shockwave group and of number needed to treat has to be interpreted with cannot substantiate the placebo effect in our study. Sec- caution because of possible differences in the study ondly, local anaesthetics were not injected into the sub- population recruited from a university hospital and acromial space to improve diagnostic accuracy. On theother hand, rotator cuff disease or subacromial the population in primary care to which we wish to shoulder pain is a clinical diagnosis and we used the recommended combination of clinical tests to improve The shoulder pain and disability index is a combined patient selection.17 Thirdly, the study may be under- score reported to be one of the most responsive powered for detecting differences in the secondary out- shoulder specific questionnaires available and more come variables. We used a univariate analysis of responsive than single subjective evaluations of pain covariance to calculate the sample size with regard to and function or objective measures of range of motion.19 The observed improvements were largestat six weeks, suggesting that a reduction of mechanicalsubacromial stress and normalisation of movement Table 4 | Patients who changed treatment or diagnosis within first 18 weeks patterns had occurred within a relatively short treat- ment period. The content of the supervised exercise intervention was slightly different from the study of Brox et al.21 Fewer patients used a sling for home exer- cises in our study; all supervision was finished within 12 weeks; and separate lessons on functional anatomy, Crossed over to supervised exercises before 18 weeks pain management, and ergonomics were not included.
Follow-up in Brox et al’s study was at three and six *One after a single treatment, and one after four treatments.
13 Zheng Z, Simpson JA, van der Windt D, Elliott AM. Data from a study After 18 weeks, supervised exercises were better than of effectiveness suggested potential prognostic factors related to thepatterns of shoulder pain. J Clin Epidemiol 2005;58:823-30.
radial extracorporeal shockwave treatment in terms of 14 Speed CA, Richards C, Nichols D, Burnet S, Wies JT, Humphreys H, the primary outcome variable—the shoulder pain and et al. Extracorporeal shock-wave therapy for tendinitis of the rotatorcuff. J Bone Joint Surg Br 2002;84:509-12.
disability index—and one secondary outcome variable 15 Schmitt J, Haake M, Tosch A, Hildebrand R, Deike B, Griss P. Low- —work status. We found no significant differences for energy extracorporeal shock-wave treatment (ESWT) for tendinitis of the other secondary outcome variables of pain, func- the supraspinatus: a prospective, randomised study. J Bone JointSurg Br 2001;83:873-6.
tion, active range of motion, and use of drug treatment.
16 Michener LA, Walsworth MK, Burnet EN. Effectiveness of More patients in the supervised exercise group rehabilitation for patients with subacromial impingement syndrome.
J Hand Ther 2004;17:152-64.
improved, probably owing to a treatment effect.
17 Park HB, Yokota A, Gill HS, El Rassi G, McFarland EG. Diagnostic We thank Stine O Eriksen for doing all the assessments, Roald Danielsen accuracy of clinical tests for the different degrees of subacromialimpingement syndrome. J Bone Joint Surg Am 2005;87:1446-55.
for administering radial extracorporeal shockwave treatment, and Mona 18 Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y.
Mortensen and Helene Skaara for leading the supervised exercises. We Development of a shoulder pain and disability index. Arthritis Care also thank Egil Knag, Enimed, for lending us the Swiss Dolor Clast. A special thanks to all the patients who made this study possible.
19 Ekeberg OM, Bautz-Holter E, Tveita EK, Keller A, Juel NG, Brox JI.
Contributors: KE contributed to the study design; data collection, analysis, Agreement, reliability and validity in 3 shoulder questionnaires in and interpretation; and writing of the manuscript. MG and JIB contributed patients with rotator cuff disease. BMC Musculoskelet Disord to the study design, data analysis and interpretation, and writing of the manuscript. EB-H contributed to the study design and data collection and 20 Tveita EK, Tariq R, Sesseng S, Juel NG, Bautz-Holter E.
interpretation. LS contributed to data analysis and interpretation. NGJ and Hydrodilatation, corticosteroids and adhesive capsulitis: a OME contributed to the study design and data collection and randomized controlled trial. BMC Musculoskelet Disord 2008;9:53.
interpretation. KE is the guarantor.
21 Brox JI, Staff PH, Ljunggren AE, Brevik JI. Arthroscopic surgery compared with supervised exercises in patients with rotator cuff Funding: The study was supported by Health Region East, Norway.
disease (stage II impingement syndrome). BMJ 1993;307:899-903.
22 Triffitt PD, Wildin C, Hajioff D. The reproducibility of measurement of Ethical approval: The study protocol was approved by the ethics shoulder movement. Acta Orthop Scand 1999;70:322-4.
committee for Medical Research Region 1 of Norway.
23 Holm I, Friis A, Storheim K, Brox JI. Measuring self-reported functional status and pain in patients with chronic low back pain by postalquestionnaires: a reliability study. Spine 2003;28:828-33.
Faber E, Kuiper JI, Burdorf A, Miedema HS, Verhaar JA. Treatment ofimpingement syndrome: a systematic review of the effects on 24 Virta L, Mortensen M, Eriksson R, Âller M. How many patients with functional limitations and return to work. J Occup Rehabil subacromial impingement syndrome recover with physiotherapy? A follow-up study of a supervised exercise programme. Adv Physiother Brox JI. Shoulder pain. Best Pract Res Clin Rheumatol 2003;17:33-56.
Blaine TA, Kim YS, Voloshin I, Chen D, Murakami K, Chang SS, et al.
25 Gerdesmeyer L, Gollwitzer H, Diehl P, Wagner K. Radial The molecular pathophysiology of subacromial bursitis in rotator cuff extracorporeal shockwave therapy (rESWT) in orthopaedics. J Miner disease. J Shoulder Elbow Surg 2005;14(1 suppl S):84-9S.
Green S, Buchbinder R, Glazier R, Forbes A. Systematic review of 26 Williams JW, Hollemann DR, Simmel DL. Measuring shoulder randomised controlled trials of interventions for painful shoulder: function with the shoulder pain and disability index. J Rheumatol selection criteria, outcome assessment, and efficacy. BMJ 27 Frison L, Pocock SJ. Repeated measures in clinical trials: analysis Bohmer A, Staff PH, Brox JI. Supervised exercises in relation to rotator using mean summary statistics and its implications for design. Stat cuff disease (impingement syndrome, stages 1 and II): a treatment regimen and its rationale. Physiother Theory Pract 1998;14:93-105.
28 Fitzmaurice GM. Applied longitudinal analysis. Hoboken, NJ: Wiley- Harniman E, Carette S, Kennedy C, Beaton D. Extracorporeal shock wave therapy for calcific and noncalcific tendonitis of the rotator cuff: 29 Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS.
a systematic review. J Hand Ther 2004;17:132-51.
Interpreting treatment effects in randomised trials. BMJ Cacchio A, Paoloni M, Barile A, Don R, de Paulis F, Calvisi V, et al.
Effectiveness of radial shock-wave therapy for calcific tendinitis of 30 Vickers AJ. Parametric versus non-parametric statistics in the the shoulder: single-blind, randomized clinical study. Phys Ther analysis of randomized trials with non-normally distributed data.
Buchbinder R, Green S, Youd JM. Corticosteroid injections for 31 Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev 2003;(1):CD004016.
shoulder pain. Cochrane Database Syst Rev 2003;(2):CD004258.
Hay EM, Thomas E, Paterson SM, Dziedzic K, Croft PR. A pragmatic 32 Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wortler K, randomised controlled trial of local corticosteroid injection and et al. Extracorporeal shock wave therapy for the treatment of chronic physiotherapy for the treatment of new episodes of unilateral calcifying tendonitis of the rotator cuff: a randomized controlled trial.
shoulder pain in primary care. Ann Rheum Dis 2003;62:394-9.
10 Lombardi I Jr, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive 33 De Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement resistance training in patients with shoulder impingement syndrome: versus reliability measures. J Clin Epidemiol 2006;59:1033-9.
a randomized controlled trial. Arthritis Rheum 2008;59:615-22.
34 De Vet HC, Ostelo R, Terwee C, van der Roer N, Knol D, Beckerman H, 11 Coghlan JA, Buchbinder R, Green S, Johnston RV, Bell SN. Surgery for et al. Minimally important change determined by a visual method rotator cuff disease. Cochrane Database Syst Rev integrating an anchor-based and a distribution-based approach.
12 Unruh AM. Gender variations in clinical pain experience. Pain

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