Open AccessA Randomized Placebo‐Controlled Study of Noninvasive Cortical Electrostimulation in the Treatment of Fibromyalgia Patients
Author(s) -
Hargrove Jeffrey B.,
Bennett Robert M.,
Simons David G.,
Smith Susan J.,
Nagpal Sunil,
Deering Donald E.
Publication year - 2012
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/j.1526-4637.2011.01292.x
Subject(s) - medicine , fibromyalgia , placebo , tolerability , physical therapy , randomized controlled trial , beck depression inventory , clinical trial , adverse effect , anxiety , psychiatry , alternative medicine , pathology
Objective. The aim of this multicenter study was to evaluate the efficacy, safety, and tolerability of noninvasive cortical electrostimulation in the management of fibromyalgia (FM). Design. A prospective, randomized, double‐blind, placebo‐controlled design was used. Setting. Subjects received therapy at two different outpatient clinical locations. Patients. There were 77 subjects meeting the American College of Rheumatology 1990 classification criteria for FM. Intervention. Thirty‐nine (39) active treatment (AT) FM patients and 38 placebo controls received 22 applications of either noninvasive cortical electrostimulation or a sham therapy over an 11‐week period. Outcome Measures. The primary outcome measures were the number of tender points (TePs) and pressure pain threshold (PPT). Secondary outcome measures were responses to the Fibromyalgia Impact Questionnaire (FIQ), Symptom Checklist‐90 (SCL‐90), Beck Depression Inventory‐II, and a novel sleep questionnaire, all evaluated at baseline and at the end of treatment. Results. Intervention provided significant improvements in TeP measures: compared with placebo, the AT patients improved in the number of positive TePs (−7.4 vs −0.2, P < 0.001) and the PPT (19.6 vs −3.2, P < 0.001). Most secondary outcomes also improved more in the AT group: total FIQ score (−15.5 vs −5.6, P = 0.03), FIQ pain (−2.0 vs −0.6, P = 0.03), FIQ fatigue (−2.0 vs −0.4, P = 0.02), and FIQ refreshing sleep (−2.1 vs −0.7, P = 0.02); and while FIQ function improved (−1.0 vs −0.2), the between‐group change had a 14% likelihood of occurring due to chance ( P = 0.14). There were no significant side effects observed. Conclusions. Noninvasive cortical electrostimulation in FM patients provided modest improvements in pain, TeP measures, fatigue, and sleep; and the treatment was well tolerated. This form of therapy could potentially provide worthwhile adjunctive symptom relief for FM patients.