A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients.

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.

Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation.

OBJECTIVE: To evaluate long-term outcomes of a noninvasive cortical stimulation technology in the treatment of fibromyalgia (FM). DESIGN: After trial follow-up survey of subjects who had completed a randomized, controlled, double-blind study of noninvasive cortical stimulation therapy some 45 months previously. SETTING: General community. PARTICIPANTS: Patients with FM (N=69) who participated in the previous study, 39 of whom were mailed surveys. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Changes in the Fibromyalgia Impact Questionnaire. RESULTS: There was a 64% survey return rate. The total Fibromyalgia Impact Questionnaire score was 52.6 at baseline, 35.7 at end of study, and 31.8 at follow-up (P<.001). Subjects reported symptom improvements lasting at least 2 years, with a reduction or elimination of medicine use and need to see physicians for FM. CONCLUSIONS: A high percentage of patients with FM treated with noninvasive cortical stimulation continued to experience worthwhile improvement at follow-up.

Quantitative electroencephalographic abnormalities in fibromyalgia patients.

There is increasing acceptance that pain in fibromyalgia (FM) is a result of dysfunctional sensory processing in the spinal cord and brain, and a number of recent imaging studies have demonstrated abnormal central mechanisms. The objective of this report is to statistically compare quantitative electroencephalogram (qEEG) measures in 85 FM patients with age and gender matched controls in a normative database. A statistically significant sample (minimum 60 seconds from each subject) of artifact-free EEG data exhibiting a minimum split-half reliability ratio of 0.95 and test-retest reliability ratio of 0.90 was used as the threshold for acceptable data inclusion. FM subject EEG data was compared to EEGs of age and gender matched healthy subjects in the Lifespan Normative Database and analyzed using NeuroGuide 2.0 software. Analyses were based on spectral absolute power, relative power and coherence. Clinical evaluations included the Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory and Fischer dolorimetry for pain pressure thresholds. Based on Z-statistic findings, the EEGs from FM subjects differed from matched controls in the normative database in three features: (1) reduced EEG spectral absolute power in the frontal International 10-20 EEG measurement sites, particularly in the low- to mid-frequency EEG spectral segments; (2) elevated spectral relative power of high frequency components in frontal/central EEG measurement sites; and (3) widespread hypocoherence, particularly in low- to mid-frequency EEG spectral segments, in the frontal EEG measurement sites. A consistent and significant negative correlation was found between pain severity and the magnitude of the EEG abnormalities. No relationship between EEG findings and medicine use was found. It is concluded that qEEG analysis reveals significant differences between FM patients compared to age and gender matched healthy controls in a normative database, and has the potential to be a clinically useful tool for assessing brain function in FM patients.