Engebretsen 2009.

Methods	Study design: parallel‐group, two‐arm, single‐blind, RCT Setting: outpatient clinic of the Physical Medicine and Rehabilitation Department at Ullevaal University Hospital, Oslo, Norway Trial time period: July 2006 to August 2007 Interventions: rESWT vs supervised exercises Sample size calculation: study designed to detect a difference of 10 points in SPADI score between groups with α = 0.05 (type I error) and β = 0.2 (type II error). 48 participants were required per group to detect a 10‐point change in SPADI score with a 20‐point SD. Analysis: ITT
Participants	Number of participants: screened for eligibility: 141 (31 not meeting inclusion criteria, 2 refused participation, 4 other reasons) randomised: 104 (52 in rESWT; 52 in supervised exercises) included in analyses at 6 weeks: 90 (44 in rESWT; 46 in supervised exercises) at 12 weeks' follow‐up: 102 (52 in rESWT; 50 in supervised exercises) at 18 weeks' follow‐up: 100 (50 in rESWT (2 crossed over to the exercise group); 50 in supervised exercises) at 12 months' follow‐up: 97 (48 in rESWT; 49 in supervised exercises) included in analysis: 94 (46 in rESWT; 48 in supervised exercises) Inclusion criteria subacromial shoulder pain lasting ≥ 3 months and aged 18–70 years dysfunction or pain on abduction had a normal passive glenohumeral ROM pain during 2 of 3 isometric tests (abduction, external‐ or internal rotation at 0 degrees or 30 degrees) positive Hawkins‐Kennedys test people with rotator cuff rupture were included if they fulfilled the above criteria Exclusion criteria bilateral shoulder pain previous surgery on the affected shoulder had multidirectional instability clinical signs of a cervical syndrome rheumatoid arthritis clinical and radiological signs of glenohumeral or acromioclavicular joint pathology inability to understand spoken or written Norwegian considerable emotional distress needed anticoagulant medicine pregnancy previous experience of 1 of the study interventions unwillingness to accept either of the interventions in study Baseline characteristics: Radial ESWT (52 participants): mean (SD) age: 47 (11.7) years number male/female: 26/26 number (%) of symptoms: at 3 to 6 months: 15 (29); at 6 to 12 months: 15 (29); at 12 to 24 months: 6 (12); at > 24 months: 16 (31) number (%) treatment history: 24 (46) physiotherapy, 20 (38) corticosteroid injection mean (SD) EQ‐VAS 0–100, 100 indicating best health: 62.9 (20.1) Median (IQR) EQ‐5D Index: 0.74 (0.58–0.76) mean (SD) pain at rest on VAS 0–9: 3.5 (2.1) mean (SD) function SPADI 0–100 score: 45.1 (22.1) Supervised exercises (52 participants): mean (SD) age: 49 (9.3) years number male/female: 26/26 number (%) of symptoms: at 3–6 months: 19 (37); at 6–12 months: 15 (29); at 12–24 months: 8 (15); at > 24 months: 10 (19) number (%) treatment history: 23 (44) physiotherapy, 27 (52) corticosteroid injection mean (SD) EQ‐VAS 0–100, 100 indicating best health: 72.4 (15.2) Median (IQR) EQ‐5D Index: 0.70 (0.53–0.76) mean (SD) pain at rest on VAS 0–9: 3.4 (1.9) mean (SD) function on SPADI 0–100 score: 48.8 (20.6) Pretreatment group differences: groups similar at baseline with regard to demographic and outcome variables.
Interventions	rESWT: description of modality used: Swiss Dolor Clast, EMS) was provided by a physiotherapist experienced in its use. method of administration: 3–5 tender points were treated each time. Points were identified through a participant‐oriented biofeedback process (insertion of supraspinatus tendon, dorsolaterally below the acromion and a maximum of 3 trigger points in rotator cuff muscles). rESWT uses low to medium energy shock waves generated when a projectile is accelerated by compressed air and hits an applicator. These impulses are delivered into the tissue and spread as spherical 'radial' waves (rather than being focused). Participants were informed that the suggested mechanism for pain relief was hyperstimulation analgesia and increased neurovascularisation that improves regeneration of tissue. Participants were advised to avoid activities that elicited pain dose: 2000 pulses per session in a frequency of 12–8 Hz with a pressure 2.5–4.0 bar, depending on what the participant tolerated without an anaesthetic frequency: 1 session weekly for 4–6 weeks co‐interventions: all participants were asked not to have any additional treatment except analgesics (including anti‐inflammatory drugs) for their shoulder pain for the time between the start of treatment and the 18 weeks' follow‐up Supervised exercises: method of administration: the principle focus was on relearning of normal movement patterns, which could then be transferred to daily activities. The initial aim was to unload the stress on the rotator cuff and subacromial structures. During this phase, a mirror for awareness of posture, an elastic rubber band and a sling fixed to the ceiling were used. The participants received immediate feedback and correction (supervision) by the physiotherapist. Once dysfunctional neuromuscular patterns were normalised, endurance exercises were performed with gradually increasing resistance dose: 45 minutes frequency: 2 sessions weekly for up to 12 weeks co‐interventions: participants had an adjusted programme at home, which consisted of correction of alignment during daily living and simple low loaded exercises with a thin elastic cord to provide assistance and resistance to the movement. Simple advice was given. All the participants were asked not to have any additional treatment except analgesics (including anti‐inflammatory drugs) for their shoulder pain for the time between the start of treatment and the 18 weeks' follow‐up
Outcomes	Outcomes measured at baseline, 6 weeks, 12 weeks, 18 weeks and 1 year Outcomes included in review function measured by SPADI; score: 0–100, higher score indicating worse shoulder pain and disability. A version adapted to Norwegian language and culture, translated and back‐translated was used rest pain in previous week measured on 1‐ to 9‐point scale (1 no pain, 9 severe pain) withdrawal due to adverse events, intolerance to treatment or other reasons proportion of participants with adverse events active range of abduction (at 5‐degree intervals) Outcomes excluded from review functional scales: can you carry a shopping bag (5 kg) and Can you take down something from a wall cupboard, measured on 1‐ to 7‐point scale (1 easy, 7 impossible) pain during activity work status use of drug treatment
Source of funding	Study supported by Health Region East, Norway
Notes	Trial registration: ClinicalTrials.gov identifier NCT00653081 Time points included in review: 6 weeks and 12 months Data analysis: author provided unpublished information: mean age of cohort participants and duration of symptoms, methods of randomisation and allocation concealment, attrition rates, active range of abduction (mean and SD). 13/52 in shock wave group and 3/52 in exercise group received additional treatment (cortisone injections, chiropractic treatment, physical therapy or supervised exercises) between 12 and 18 weeks. Withdrawals: 4/52 in shock wave group (1 death, 1 loss to follow‐up, 2 incomplete questionnaires) and 3/52 in exercise group (2 loss to follow‐up, 1 incomplete questionnaire) Adverse events: RSWT: serious adverse events: 0/52 other adverse events: 3/52 (severe pain following treatment and dropped out from intervention) Supervised exercises: serious adverse events: 0/52 other adverse events: 1/52 (increase in pain and stiffness consistent with adhesive capsulitis and discontinued intervention)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A statistician not involved in data collection or analysis randomly allocated patients to treatment groups in blocks of four to six. Randomisation was stratified by sex." Comment: adequate method used to generate the allocation sequence.
Allocation concealment (selection bias)	Low risk	Quote: "A person not involved in the treatments opened the sealed envelopes and assigned appointments according to treatment group." Comment: adequate method likely used to conceal the allocation sequence.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Participants and personnel could not be blinded for this trial." Comment: given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of each intervention.
Blinding of outcome assessment (detection bias) Self‐reported outcomes	High risk	Comment: unblinded participants, who may have had different expectations about the benefits of the intervention they received.
Blinding of outcome assessment (detection bias) Assessor‐reported outcomes	Low risk	Quote: "A blinded physiotherapist made the baseline and follow‐up measurements. The patients were instructed not to discuss their treatment with the blinded physiotherapist." Comment: assessor of objective outcomes was likely blinded to the intervention.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 10 participants per group did not return for all follow‐up measures, and while reasons for loss to follow‐up were not reported, an ITT analysis was performed; 7/104; 4/52 in shock wave group (1 death, 1 loss to follow‐up, 2 incomplete questionnaires) and 3/52 in exercise group (2 loss to follow‐up, 1 incomplete questionnaire).
Selective reporting (reporting bias)	Low risk	Active ROM data were not reported; the authors supplied the unpublished data upon request. Function, work status were not listed in trial protocol but were in results paper.
Other bias	High risk	More people in shock wave group received additional treatments outside of the trial setting, including injection, physiotherapy or chiropractice (13 from shock wave vs 3 from exercise), which may have biased the results in their favour.