Szcurko 2009.
Methods | RCT; randomised using age‐ and sex‐matched central computer randomisation | |
Participants | Postal workers with rotator cuff tendinitis; n = 89 | |
Interventions |
PE: standardised physical exercises: range‐of‐motion exercises + placebo tablets; n = 42 NC: Naturopathic care: dietary counselling, acupuncture and Plogenzym; n = 43 12 weeks, one weekly session of 30 minutes |
|
Outcomes | Pain (VAS), function (SPADI), quality of life (SF‐36) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomized using age and sex matched computer randomization" |
Allocation concealment (selection bias) | Low risk | "Allocation concealment using central randomization was preserved up to the point of treatment" |
Blinding of participants? | High risk | Participant was not blinded |
Blinding of caregivers? | Unclear risk | Unclear blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "Primary outcome is measured by patient and participant blinding is 'no'" |
Incomplete outcome data (attrition bias) All outcomes ‐ <20% drop‐outs? | Low risk | Of 85 participants, 17 did not complete treatment (= 20%) |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis performed? | Low risk | Missing data at week 12 were replaced by values at week 8 for ITT analysis |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Similarity of baseline characteristics? | High risk | No adequate baseline comparability: see Table 1 |
Co‐interventions avoided? | High risk | Co‐interventions not similar between groups |
Compliance acceptable ? | Low risk | Compliance for pills > 80%. Same number and duration of sessions for other groups |
Timing outcome assessment comparable? | Low risk | Timing was comparable |