Methods |
Design: three group parallel trial
Purpose: examine the effect of acupuncture on chronic low back pain |
Participants |
Patients: patients with low back pain of more than 6 weeks duration
Baseline comparability: yes (age, pain) |
Interventions |
Placebo: superficial needling at sites not regarded acupuncture sites (12 sessions over 4 weeks)
Untreated: no needling
Experimental: needling at acupuncture sites
(Co‐intervention: conservative orthopaedic treatment (physiotherapy, exercise, back school, mud packs, infrared heat therapy, and diclofenac on demand)) |
Outcomes |
Proportion of patients with 50% reduction of 100 mm pain VAS at one month
Proportion of patients with 50% reduction of 100 mm pain VAS at follow‐up
Proportion of patients with excellent or good ratings on a four‐point box scale |
Notes |
According to protocol we extracted the post treatment outcome data at one month, overruling a secondary principle of extracting the primary outcome of a trial (follow up data at three months). The effect of placebo was neutral at post treatment (RR = 1.16, 0.86 to 1.56), but positive at follow‐up (RR = 0.64, 0.43 to 0.95). The drop out rate in the two groups was (3+7)/121 = 8% at one month, and (19+23)/121 = 35% at three months. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
'computer generated randomisation list' |
Allocation concealment? |
Low risk |
'central telephone randomisation' |
Blinding?
Treatment provider |
Unclear risk |
NS |
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? |
Unclear risk |
No protocol available |
Free of other bias? |
High risk |
See notes |
No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
Trial size > 49? |
Low risk |
N = 111 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |