| Methods |
Study design: multicentre, parallel‐group, three‐arm, double‐blind, randomised, placebo‐controlled trial
Setting: 7 orthopaedic departments in Germany and Austria
Trial time period: February 1997 to March 2001
Interventions: high‐energy ESWT vs low‐energy ESWT vs sham therapy
Sample size calculation: 144 participants would have 90% power to find a 15% difference in Constant score between therapy and placebo, given α = 0.025.
Analysis: ITT analysis was used for primary outcomes, with missing data imputed using last observation carried forward |
| Participants |
Number of participants:
screened: 164 (20 excluded: 12 did not meet inclusion, 7 refused participation, 1 withdrew with no reason reported) randomised: 144 (48 per group) in 3‐month analysis: 132 (44 in high‐dose group; 46 in low‐dose group; 42 in placebo group) in 6‐month analysis: 134 (47 in high‐dose group; 46 in low‐dose group; 41 in placebo group) in 12‐month analysis: 111 (35 in high‐dose group; 44 in low‐dose group; 32 in placebo group)
Inclusion criteria:
pain or tenderness from idiopathic calcific tendonitis, for a minimum of 6 months type I or II Gärtner calcific deposits resistant to conservative treatment calcific deposits of ≥ 5 mm in diameter on radiography aged ≥ 18 years previous conservative treatments, including both physiotherapy (active and passive exercise, mobilisation, manual therapy and massage, muscle strengthening) and local anaesthetic or corticosteroid injection, NSAID
Exclusion criteria:
rotator cuff tears subacromial bursitis type III Gärtner calcific deposits rheumatic disease connective tissue disease diabetes coagulation disturbance pregnancy glenohumeral or acromioclavicular joint arthritis previous surgery for shoulder pain bursitis or infection of the shoulder tumour of the shoulder instability of the shoulder or rotator cuff tear abnormal peripheral neurological findings unsuccessful prior ESWT
Baseline characteristics:
High‐dose ESWT (48 participants):
mean (SD) age: 51.6 (8.5) years number male/female: 13/35 mean (SD) calcific deposit size: 182 (135) mm² number (%) deposit classification: type I = 34 (71), type II = 14 (29) mean (SD) duration of pain: 42.6 (23.2) months mean (SD) function, Constant 0–100: 60 (11) mean (SD) pain score, VAS 0–10: 6.5 (1.3)
Low‐dose ESWT (48 participants)
mean (SD) age: 47.3 (8.5) years number male/female: 16/32 mean (SD) calcific deposit size: 195 (166) mm² number (%) deposit classification: type I = 30 (63), type II = 18 (37) mean (SD) duration of pain: 42.8 (25.2) months mean (SD) function, Constant 0–100: 62.7 (14.0) mean (SD) pain score, VAS 0–10: 5.7 (1.9)
Sham treatment (48 participants):
mean (SD) age: 52.3 (9.8) years number male/female: 28/20 mean (SD) calcific deposit size: 128 (112) mm² number (%) deposit classification: type I = 32 (67), type II = 16 (33) mean (SD) duration of pain: 41.3 (28.6) months mean (SD) function, Constant 0–100: 64.2 (12.8) mean (SD) pain score, VAS 0–10: 5.6 (1.6)
Pretreatment group differences: no group differences were found at baseline with the exception of the calcific deposit which was smaller in sham group compared to the ESWT group |
| Interventions |
High‐energy ESWT:
description of modality: ESWT device (Domier Medlizintechnilk, Wessling, Germany) method of administration: all participants had ≥ 1‐month therapy‐free period before the first treatment with ESWT. Participants were placed in prone position. Using fluoroscopy in an anteroposterior view, the shoulder was rotated until the calcific deposit was identified in a free position. A shock wave head was coupled to the shoulder with a thin sheet of polyethylene foil placed between the shock wave head and the participant. Coupling gel was used between the shock head and the foil and between the foil and the shoulder. dose: 1500 shock waves of 0.32 mJ/mm² per treatment. 120 impulses were applied per minute. frequency: 2 treatment sessions. Second session after 12–16 days co‐interventions: 10 physiotherapy sessions after the intervention (included active and passive exercise mobilisation techniques, massage and manual therapy to prevent worsening in ROM, muscular deficit or imbalance). Adequate intravenous analgesia and sedation were provided as necessary. Local anaesthetics were prohibited. Rescue medication allowed during the entire study (paracetamol 2 g/day for up to 14 days following the last ESWT; if needed thereafter paracetamol 2 g/week). No other treatment or other NSAIDs were allowed until after the 6 months' follow‐up.
Low‐energy ESWT:
description of modality: ESWT device (Domier Medlizintechnilk, Wessling, Germany) method of administration: as described above dose: 6000 shock waves of 0.08 mJ/mm² per treatment. 120 impulses were applied per minute. frequency: 2 treatment sessions. Second session after 12–16 days co‐interventions: as above
Sham treatment:
description of modality: ESWT device (Domier Medlizintechnilk, Wessling, Germany) shock waves blocked by an air‐chambered polyethylene foil method of administration: an air‐chambered polyethylene foil with coupling gel was placed against the participant's skin, but no coupling gel was applied to the site of the shock wave head. The foil was placed between the participant and the water cushion of the ESWT device in same technique as the above‐mentioned ESWT groups. Measurements with glass‐fibre hydrophones demonstrated that no shock waves could pass through the foil. The participant's prone position prevented them from seeing the device but they could hear the typical sound of shock waves being generated dose: 1500 shock waves per treatment with 120 impulses per minute were delivered after the energy level reached the assigned treatment level of 0.32 mJ/mm²; however, none of the shock waves were transmitted to the participants frequency: 2 treatment sessions. Second session after 12–16 days co‐interventions: as above
|
| Outcomes |
Measured at baseline, 3, 6 and 12 months
Outcomes included in review:
mean change from baseline in function measured by CMS, maximum score: 100 points, higher score indicating better function mean change from baseline in pain measured on VAS 0–10, 10 indicating unbearable pain radiographic change in size of calcific deposits. The localisation of calcifications within a specific tendon was determined by anteroposterior X‐rays of the shoulder obtained in 45 degrees external and 45 degrees internal rotation adverse events treatment success measured by proportion with 30% improvement measured by a 30% increase from baseline on CMS withdrawals: due to adverse events, intolerance to treatment or other reasons
Outcomes excluded from review:
|
| Source of funding |
Supported by the German Association for Orthopedics and Orthopedic Surgery (DGOCC). Shock wave equipment supplied by Domier Medlizintechnilk, Wessling, Germany. |
| Notes |
Trial registration: not reported
Time points included in review: 3, 6 and 12 months
Data analysis: as there were 2 intervention groups, the low‐energy group data were used for the comparison ESWT vs sham as it was more consistent with the energy levels used in other trials. The high‐energy group and low‐energy group were used for the comparison high vs low dose. The 95% CI was converted to a SD using the following equation in excel: (('upper CI' – 'lower CI')/3.92) × √'population'). Results were then rounded to 1 decimal place. Proportion of participants with ≥ 30% increase in CMS, noted in trial as a clinically relevant improvement, was taken as the measure of treatment success. As proportion of participants who experienced adverse events was reported by category of adverse event, the largest number from any category was used in data extraction as a best estimate.
Withdrawals: 13/48 in high‐dose ESWT group (7 refused follow‐up visit, 6 reported no reason): 4/48 in low‐dose ESWT group (2 had drug therapy and 2 had surgery) and 18/48 in placebo group (7 had drug therapy, 5 had surgery, 5 refused follow‐up visits, 1 moved). We assumed 4/48 in ESWT and 12/48 in placebo were intolerant to treatment (Analysis 1.5).
Adverse events:
High‐dose ESWT:
serious adverse events: 0/48 other adverse events: 36/48 (36/48 reported pain during treatment (20 moderate pain;16 severe pain out of which 8 required intravenous analgesics); 36/48 reported petechiae, bleeding, erythema or haematoma)
Low‐dose ESWT:
serious adverse events: 0/48 other adverse events: 32/48 (27/48 reported pain during treatment (22 moderate pain; 5 severe pain out of which 2 had intravenous analgesics); 32/48 reported petechiae, bleeding, erythema or haematoma)
Sham treatment:
serious adverse events: 0/48 other adverse events: 25/48 (25/48 reported pain (21 moderate pain; 4 severe pain out of which 1 had intravenous analgesics); 8/48 reported petechiae, bleeding, erythema or haematoma)
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomisation using a computer‐generated sequence at a central location. |
| Allocation concealment (selection bias) |
Low risk |
Sealed opaque envelopes stored at a central location, allocation by telephone. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Participants and evaluators were reported as blinded to treatment; however as intravenous analgesics and sedation were offered 'as needed', and local anaesthetic was not allowed, it was unclear if participants could guess their assignment. |
| Blinding of outcome assessment (detection bias)
Self‐reported outcomes |
Unclear risk |
Unclear if participants may have guessed their treatment group, thus reporting of pain, function and treatment success could have been subject to bias. |
| Blinding of outcome assessment (detection bias)
Assessor‐reported outcomes |
Low risk |
Radiologists who assessed calcification were blinded to treatment allocation. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
33/144; 13/48 (27%) in high‐dose ESWT group (7 refused follow‐up visit, 6 withdrawn), 4/48 (8.3%) in low‐dose ESWT group (no reasons given) and 16/48 (33%) in sham group (5 refused follow‐up visits, 11 withdrawn). |
| Selective reporting (reporting bias) |
Low risk |
No published study protocol, but results were reported for all outcomes as mentioned in the methods, and included major outcomes. Low risk of reporting bias. |
| Other bias |
Low risk |
No other biases apparent in the study. |
