Kim 2014.
Methods |
Study design: single‐centre, parallel‐group, two‐arm, RCT Setting: orthopaedic surgery outpatient department, St Mary's Hospital, the Catholic University of Korea, Seoul, South Korea Trial time period: November 2005 to March 2011 Interventions: ESWT vs US‐guided needling Sample size calculation: 30 participants per group were needed to detect a significant difference (mean difference 8 points; SD 12 points) between groups in ASES scores, with power of 80%, at a type I error level of 0.05 Analysis: not ITT |
|
Participants |
Number of participants:
Inclusion criteria:
Exclusion criteria:
Baseline characteristics: ESWT (32 participants):
US‐guided glucocorticoid needling (30 participants):
Pretreatment group differences: none |
|
Interventions |
ESWT:
US‐guided needling:
|
|
Outcomes | Measured at 6 weeks, 12 weeks, 6 months, 12 months, and last follow‐up visit. Mean follow‐up: 23.0 (range 12.1–28.5) months after treatment Outcomes included in review:
Other outcomes in trial, excluded from review
|
|
Source of funding | The authors, their immediate families, and any research foundation with which they were affiliated received no financial payments or other benefits from any commercial entity related to the subject of the article | |
Notes |
Trial registration: not reported Time points included in review: 3, 6 and 12 months Data analysis: no SDs or any other measures of variance were reported or could be calculated for the pain scores or the function scores at follow‐up, thus we could not analyse these outcomes. The size of calcific deposits was extracted at last follow‐up (12 months) Withdrawals: 3/32 in ESWT group, 5/30 in needling group were lost to follow‐up Adverse events: not measured |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization was conducted by an independent statistician who provided us with a computer‐generated randomization list." Comment: adequate. |
Allocation concealment (selection bias) | Unclear risk | Not reported if the randomisation list was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither participants nor personnel were blinded to treatment allocation. |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | High risk | Participants were not blinded to treatment allocation, thus there was risk of detection bias in reporting of pain and function. |
Blinding of outcome assessment (detection bias) Assessor‐reported outcomes | Unclear risk | It was not reported if the radiographer assessing calcification size was blinded and the effect on measurement of this outcome was unclear. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 3/32 (9%) in ESWT group and 5/30 (16.6%) in needling group were lost to follow‐up. |
Selective reporting (reporting bias) | High risk | There was no published study protocol, and measures of variance were not reported at follow‐up for most data. |
Other bias | Low risk | No other biases apparent. |