Objective: To test effectiveness of static magnetic fields of two different
configurations, produced by magnetic sleep pads, as adjunctive therapies i
n decreasing patient pain perception and improving functional status in ind
ividuals with fibromyalgia.
Design: Randomized, placebo-controlled, 6-month trial conducted from Novemb
er 1997 through December 1998.
Setting and subjects: Adults who met the 1990 American College of Rheumatol
ogy criteria for fibromyalgia were recruited through clinical referral and
media announcements and evaluated at a university-based clinic.
Interventions: Subjects in Functional Pad A group used a pad for 6 months t
hat provided whole-body exposure to a low, uniform static magnetic field of
negative polarity. Subjects in the Functional Pad B group used a pad for 6
months that exposed them to a low static magnetic field that varied spatia
lly and in polarity. Subjects in two Sham groups used pads that were identi
cal in appearance and texture to the functional pads but contained inactive
magnets; these groups were combined for analysis. Subjects in the Usual Ca
re group continued with their established treatment regimens.
Outcome measures: Primary outcomes were the change scores at 6 months in th
e following measures: functional status (Fibromyalgia Impact Questionnaire)
, pain intensity ratings, tender point count, and a tender point pain inten
sity score.
Results: There was a significant difference among groups in pain intensity
ratings (p = 0.03), with Functional Pad A group showing the greatest reduct
ion from baseline at 6 months. All four groups showed a decline in number o
f tender points, but differences among the groups were not significant (p =
0.72). The functional pad groups showed the largest decline in total tende
r point pain intensity, but overall differences were not significant (p = 0
.25). Improvement in functional status was greatest in the functional pad g
roups, but differences among groups were not significant (p = 0.23).
Conclusions: Although the functional pad groups showed improvements in func
tional, status, pain intensity level, tender point count, and tender point
intensity after 6 months of treatment, with the exception of pain intensity
level these improvements did not differ significantly from changes in the
Sham group or in the Usual Care group.