Hearnden 2009.
Methods |
Study design: single‐centre, parallel‐group, two‐arm, single‐blind randomised placebo‐controlled trial Setting: orthopaedics referrals from general practice, Wrightington Hospital, UK Trial time period: not reported Interventions: ESWT vs placebo Sample size calculation: not performed Analysis: ITT |
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Participants |
Number of participants:
Inclusion criteria:
Exclusion criteria:
Baseline characteristics: numerical data were not reported Pretreatment group differences: authors reported that participants in both groups were well matched in demographics, symptoms and calcific deposits (no numerical data reported) |
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Interventions |
ESWT:
Placebo
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Outcomes | Measured at 6 months 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: 6 months Data analysis: function was extracted at 6 months, treatment success was extracted at the study's conclusion (6 months). Pain, calcification size and adverse events could not be extracted as the data were only reported for the intervention group. As no SDs were reported for function and there were none available in study, the SD at 6 months for active and sham groups were taken from Gerdesmeyer 2003. Withdrawals: none Adverse events: ESWT:
Placebo:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation 'using a centralised list in blocks to get two equal groups'. |
Allocation concealment (selection bias) | Low risk | Treatment allocations were kept in sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants blinded to treatment allocation, not reported if outcome assessors were blinded. |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | Participants unaware of treatment received, thus the risk of bias was low for self‐reported outcomes (pain, function and treatment success). |
Blinding of outcome assessment (detection bias) Assessor‐reported outcomes | Unclear risk | Not reported if the radiographer measuring calcification was blinded to the group allocations. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals. |
Selective reporting (reporting bias) | High risk | There was no published study protocol. The summary data for both groups were not reported. VAS pain scores and calcification changes in placebo group were not reported. |
Other bias | Low risk | No other biases apparent. |