|
Magnetic Mattress Pad Use in Patients with Fibromyalgia: a Randomized Double-blind Pilot Study.
Agatha P. Colbert, M.D.
Clinical Assistant Professor of Physical Medicine and Rehabilitation
Tufts University School of Medicine, Boston, MA 02111
Marko S Markov, Ph.D.
Department of Orthopedics
Mount Sinai School of Medicine, New York
Mandira Baneiji, M.A.
Research Assistant, Litterst & Associates, Newton, MA
Arthur A Pilla, Ph.D.
Department of Orthopedics, Mount Sinai School of Medicine, New York
Department of Biomedical Engineering, Columbia University, New York
OBJECTIVE: To determine if the chronic pain and sleep disturbances experienced by patients with fibromyalgia can be improved by sleeping on a magnetic mattress pad.
PATIENTS: Thirty-five female subjects diagnosed with fibromyalgia
syndrome were recruited. Thirty met inclusion/exclusion criteria and
entered the study. Twenty-five completed it. One was lost to follow-up.
Three were withdrawn for protocol violations and one because of an
intercurrent hospitalization.
INTERVENTION: Sleeping on an experimental (magnetized at a magnet
surface field strength of 1100 +/- 50 Gauss and delivering 200-600 Gauss
to the skin surface or a sham (non-magnetized) mattress pad over a 16
week period.
MAIN OUTCOME MEASURES: Visual Analog Scales (VAS) for global
well-being, pain, sleep, fatigue and tiredness on awakening; Total
Myalgic Score; Pain Distribution Drawings; and a modified Fibromyalgia
Impact Questionnaire.
RESULTS: Subjects sleeping on the experimental mattress pad
experienced a significant decrease in pain ~ <.05), fatigue
~<.006), total myalgic score ~ <.03), and pain distribution
drawing (1) <.02). Additionally, these subjects showed significant
improvement in reported sleep (p <.01) and physical functioning as
evidenced from the modified Fibromyalgia Impact Questionnaire ~
<.04). Subjects sleeping on the sham mattress pad experienced no
significant change in these same outcome measures. Subjects in both the
control and experimental groups showed improvement in tiredness on
wakening, demonstrating a placebo effect in this parameter. Neither
group showed any effect on global wellbeing.
CONCLUSIONS: Sleeping on a magnetic mattress pad,
with a magnet surface field strength of 1100 +/- 50 Gauss, delivering
200-600 Gauss at the skin surface provides statistically significant and
clinically relevant pain relief and sleep improvement in subjects with
fibromyalgia. No adverse reactions were noted during the 16-week trial
period.
Journal of Back and Musculoskeletal Rehabilitation 13(1999) 19-31
Return to top
Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial.
Alfano AP, Taylor AG, Foresman PA, Dunkl PR, McConnell GG, Conaway MR, Gillies GT.
Department of Physical Medicine and Rehabilitation, University of
Virginia Health System, Charlottesville, USA. apa6r@virginia.edu
OBJECTIVE: To test effectiveness of static magnetic fields of two
different configurations, produced by magnetic sleep pads, as adjunctive
therapies in decreasing patient pain perception and improving
functional status in individuals with fibromyalgia.
DESIGN: Randomized, placebo-controlled, 6-month trial conducted from November 1997 through December 1998.
SETTING AND SUBJECTS: Adults who met the 1990 American College of
Rheumatology 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 that 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 spatially and in polarity. Subjects in two Sham
groups used pads that were identical in appearance and texture to the
functional pads but contained inactive magnets; these groups were
combined for analysis. Subjects in the Usual Care group continued with
their established treatment regimens.
OUTCOME MEASURES: Primary outcomes were the change scores at 6 months
in the following measures: functional status (Fibromyalgia Impact
Questionnaire), pain intensity ratings, tender point count, and a tender
point pain intensity score.
RESULTS: There was a significant difference among groups in pain
intensity ratings (p = 0.03), with Functional Pad A group showing the
greatest reduction from baseline at 6 months. All four groups showed a
decline in number of tender points, but differences among the groups
were not significant (p = 0.72). The functional pad groups showed the
largest decline in total tender point pain intensity, but overall
differences were not significant (p = 0.25). Improvement in functional
status was greatest in the functional pad groups, but differences among
groups were not significant (p = 0.23).
CONCLUSIONS: Although the functional pad groups showed improvements
in functional 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.
J Altern Complement Med 2001 Feb;7(1):53-64
Return to top |
