Haake 2002.
Methods |
Study design: parallel‐group, two‐arm, single‐blind, RCT Setting: Germany Trial time period: participant enrolment from September 1998 to December 1999 Interventions: ESWT focused on the origin of supraspinatus tendon vs ESWT focused on the calcific deposit Sample size calculation: sample size calculation not performed Analysis: ITT |
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Participants |
Number of participants:
Inclusion criteria
Exclusion criteria
Baseline characteristics: ESWT to supraspinatus tendon (25 participants):
ESWT to calcific deposit (25 participants):
Pretreatment group differences: none |
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Interventions |
ESWT to supraspinatus tendon
ESWT to calcific deposit
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Outcomes | Measured at 12 weeks and 1 year Outcomes included in review:
Outcomes excluded from review:
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Source of funding | Not reported | |
Notes |
Trial registration: not reported Time points included in review: 12 weeks and 12 months Data analysis: function and pain at rest extracted at 12 weeks and 1 year; resorption of calcific deposit extracted at 1 year; participant satisfaction extracted at end of study period. Participant satisfaction was extracted as the measure to represent treatment success, over the number achieving 80% of the normal value for the age‐standardised Constant score Withdrawals: 1/25 in ESWT to supraspinatus tendon group (withdrew consent after randomisation); 0/25 in ESWT to calcific deposit group Adverse events: ESWT to supraspinatus tendon:
ESWT to calcific deposit:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation in permutated blocks. |
Allocation concealment (selection bias) | Unclear risk | Methods not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and outcome assessors blinded to treatment assignments. |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | Participants blinded to treatment allocation, thus there was a low risk of detection bias in reporting of self‐reported outcomes (including pain, function and patient satisfaction). |
Blinding of outcome assessment (detection bias) Assessor‐reported outcomes | Low risk | Blinded independent observers assessed other outcomes, such as radiographic assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1/25 in ESWT to supraspinatus tendon group (withdrew consent after randomisation) and 0/25 in ESWT to calcific deposit group. |
Selective reporting (reporting bias) | Low risk | No published study protocol, but results reported for all outcomes as mentioned in methods, and included major outcomes. |
Other bias | Low risk | No other biases apparent. |