| Methods |
Design: three group parallel trial
Purpose: examine the effect of acupuncture on fibromyalgia |
| Participants |
Patients: in‐patients suffering from fibromyalgia
Baseline comparability: NS |
| Interventions |
Placebo: laser acupuncture with laser off
Untreated: no acupuncture
Experimental: laser acupuncture with laser on
(Co‐intervention: physio‐, thermo‐ and electrotherapy. Fixed scheme at start of treatment. Paracetamol on demand, intake NS) |
| Outcomes |
Pain (VAS and pain threshold)
Number of positive tender points |
| Notes |
Standard deviations (SD) on 10 cm pain visual analogue scale data not reported. SD estimated from another pain RCT (Lander 1993: SD ˜ 3 cm) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random numbers' |
| 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 |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
No protocol available. Standard deviations (SD) on 10 cm pain visual analogue scale data not reported. SD estimated from another pain RCT (Lander 1993: SD ˜ 3 cm) |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
High risk |
N = 20 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
