Methods |
Design: five group parallel trial
Purpose: examine the effect of static magnetic fields for treatment of fibromyalgia |
Participants |
Patients: subjects with fibromyalgia (American College of Rheumatology's diagnostic criteria)
Baseline comparability: yes |
Interventions |
Placebo: pads that have no magnetic property inserted into the beds of the patients for 6 months
Untreated: no pads
Experimental: two types of pads with static magnetic properties
(Co‐intervention: NS) |
Outcomes |
Pain (11 point numeric rating scale, 0 to 10) at six months
Number of tender points
Tender point pain intensity
Functional status (fibromyalgia impact questionnaire) |
Notes |
Results from two placebo groups reported as deriving from one group. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
'Computer‐generated treatment list' |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
Unclear risk |
NS |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patients reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
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? |
High risk |
N = 38 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |