| Methods |
Design: three group parallel trial
Purpose: study the effect of acupuncture on osteoarthrosis of the knee |
| Participants |
Patients: older outpatients with osteoarthrosis of the knee
Baseline comparability: yes |
| Interventions |
Placebo: needling with a non‐penetrating blunt needle
Untreated: no needling
Experimental: needling at with a proper acupuncture needle
(Co‐intervention: exercise and advice) |
| Outcomes |
WOMAC pain sub‐scale
WOMAC scale
Function and general improvement |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'a computed generated randomisation'. We assume 'a computer generated randomisation' |
| Allocation concealment? |
Low risk |
After inclusion of patients into the trials the 'physiotherapist telephoned an administrator at the research centre to ... receive ... a computed generated randomisation group.' |
| Blinding?
Treatment provider |
High risk |
Acupuncturist knew type of acupuncture |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient‐reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop out <15% |
| Free of selective reporting? |
Low risk |
Protocol published. No sign of outcome selection bias for the primary outcome |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
SD x 1.67 >mean |
| Trial size > 49? |
Low risk |
N = 217 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three criteria fulfilled |
