| Methods |
Design: three group parallel trial
Purpose: study the analgesic effect of acupuncture for low‐back pain |
| Participants |
Patients: out‐patients with non‐radiating low‐back pain of more than 6 months duration
Baseline comparability: yes |
| Interventions |
Placebo: needling on sites not regarded analgesic acupuncture sites
Untreated: no needling
Experimental: needling on sites regarded analgesic acupressure sites
(Co‐intervention: active physiotherapy) |
| Outcomes |
Pain (100 mm VAS)
Pain disability (pain disability index)
Psychological distress
Spine flexion |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/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? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 79 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
