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.