| Methods |
Design: three group parallel trial
Purpose: examine the effect of acupuncture in patients with chronic low back pain |
| Participants |
Patients: patients with chronic low back pain
Baseline comparability: yes (age, gender, pain intensity) |
| Interventions |
Placebo: acupuncture on sites not regarded acupuncture sites
Untreated: no acupuncture
Experimental: acupuncture on sites regarded acupuncture sites
(Co‐intervention: All patients were allowed to take non‐steroid anti‐inflammatory drugs if necessary) |
| Outcomes |
Pain (VAS)
Back function (Funktionsfragebogen Hannover‐Rücken)
Global assessment of effect
Pain disability Index
Emotional aspects of pain (Schmertzempfindungsskala)
Depression (Allgemeine Depressionsskala)
Quality of life (SF‐36)
Number of days with pain
Number of days with pain medication |
| Notes |
Patients in the no‐treatment group took medication on 6.3 days whereas the placebo group did so on 4.9 days (weeks 5 to 8) . |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
‘a randomised list was generated using computer software [SAMPSIZE V2.0]’ |
| Allocation concealment? |
Low risk |
'Centralised telephone randomization procedure' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupressure) |
| 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 |
Primary outcome specified in protocol |
| Free of other bias? |
Unclear risk |
Patients in the no‐treatment group took medication on 6.3 days whereas the placebo group did so on 4.9 days (weeks 5 to 8) . |
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 144 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
|
