Cosentino 2003.

Methods	Study design: single‐centre, parallel‐group, two‐arm, single‐blind, RCT Setting: Italy Trial time period: not reported Interventions: ESWT vs sham procedure Sample size calculation: not performed Analysis: method was not described
Participants	Number of participants screened for eligibility: not reported randomised: 70 (35 per treatment group) included in analyses: 70 at 1 month (35 per group), 47 at 6 months (35 in shock wave and 12 in placebo) Inclusion criteria chronic, symptomatic, calcifying tendinitis of the shoulder (with a minimum diameter of 10 mm in anteroposterior X‐ray films), with pain for a minimum of 10 months calcific deposits were non‐homogeneous and located in supraspinatus tendon unsuccessful conservative treatment during the 6 months before referral to the research based at the hospital Exclusion criteria local and generalised arthritis osteoarthritis algodystrophy pregnancy infectious or tumour diseases skin ulcerations neurological abnormalities dysfunction in neck or thoracic region or both partial or complete ruptures of the rotator cuff seen by sonography Baseline characteristics: ESWT (35 participants): number male/female: 15/20 mean (range) duration of symptoms: 15 (10–20) months mean Constant 0–100 score: total 45, pain 5.2, ADL 9.6, ROM 23.2, power 7 treatment history: 35 analgesics and NSAIDs, 25 local steroid injections, 10 physiotherapy, 2 needling calcification size: not reported Sham procedure (35 participants): number male/female: 12/23 mean (range) duration of symptoms: 14.5 (10–18) months mean Constant 0–100 score: 48 (range 22–84 points) other values not reported treatment history: 35 analgesics and NSAIDs, 28 local steroid injections, 7 physiotherapy, 3 needling calcification size: not reported Pretreatment group differences: not reported
Interventions	ESWT: description of modality: ESWT system Orthima by Direx Medical System Ltd method of administration: participants were seated in front of the shock wave generator and the shock wave source was placed in direction of the calcification that was identified during sonographic examination. No local anaesthetics, analgesics or NSAIDs were used during the procedure dose: 1200 shocks with a frequency of 120 shocks per minute delivered each treatment. Because pain could occur mostly during the first treatment, all participants were treated with a low‐energy density of 0.03 mJ/mm² for the first 5 minutes, which was then progressively increased to 0.28 mJ/mm². Successive treatments used an energy density of 0.28 mJ/mm². frequency: 4 treatments (1 every 4–7 days) co‐interventions: none Sham procedure: description of modality: as above method of administration: as above dose: 1200 shocks with a frequency of 120 shocks per minute, the energy density was set to 0 mJ/mm² frequency: 4 treatments (1 every 4–7 days) co‐interventions: none
Outcomes	Pain and function measured at baseline, end of treatment, 1 month and 6 months; calcifications measured at 1 month Outcomes included in review: mean pain measured by CMS, maximum: 15 points, with a higher score indicating less pain function measured by CMS, maximum: 100 points, with a higher score indicating better function variations in dimension of the calcification evaluated by anteroposterior X‐ray film. Modification of the calcification (reduction of size > 2 mm) was indicated as disintegration; the total disappearance was indicated as dissolution adverse events withdrawals due to adverse events, intolerance to treatment or other reasons Outcomes excluded from review: ADL power ROM
Source of funding	No source of funding reported
Notes	Trial registration: not registered Time points included in review: 1 and 6 months Data analysis: trialists did not report pain for the sham group, thus we excluded this study from Analysis 1.2. Trialists did not report the number of withdrawals from the shock wave group; we excluded this study from Analysis 1.5. The mean Constant score was extracted using the WebPlotDigitier program found at arohatgi.info/WebPlotDigitizer/app. It was unclear whether the graph also displayed SE or SD; we assumed SD. Where extracted numbers differed from a reported figure, the reported figure was used. Proportion of participants with adverse events was reported as 0 for both groups (apart from initial transient treatment pain, although the number of participants with the event in each group was not explicitly reported) Withdrawals: 23/35 participants from the sham group and 0/35 from the shock wave group at 6 months' follow‐up. No reasons for withdrawal were given. Adverse events: ESWT: serious adverse events: 0/35 other adverse events: 0/35 Sham procedure: serious adverse events: 0/35 other adverse events: 0/35
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Study personnel not blinded; however, the radiologist assessing calcifications was blinded. Participants blinded to group allocations.
Blinding of outcome assessment (detection bias) Self‐reported outcomes	Low risk	Due to blinding of participants, there was low risk of bias in reporting of pain and function.
Blinding of outcome assessment (detection bias) Assessor‐reported outcomes	Low risk	Radiologist who measured calcification size blinded to the group allocations, objective outcomes in Constant score were not used in this review.
Incomplete outcome data (attrition bias) All outcomes	High risk	23/35 (66%) participants were lost from the sham group at 6 months, with no reason given; 0/35 lost from the shock wave group.
Selective reporting (reporting bias)	High risk	Study outcomes not reported clearly, means given but ranges were missing for baseline values. Pain scores given only for the treatment group and not for the sham group.
Other bias	Low risk	No other biases apparent