A Randomized Placebo-Controlled Study of Noninvasive Cortical Electrostimulation in the Treatment of Fibromyalgia Patients

Authors

  • Jeffrey B. Hargrove PhD,

    Corresponding author
    1. Department of Medicine, Michigan State University College of Human Medicine, East Lansing, Michigan
    2. Department of Mechanical Engineering, Kettering University, Flint, Michigan
      Jeffrey B. Hargrove, PhD, Kettering University, 1700 University Avenue, Flint, MI 48504-6214, USA. Tel: 810-762-7437; Fax: 810-762-7860; E-mail: jhargrov@kettering.edu.
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  • Robert M. Bennett MD,

    1. Schools of Medicine and Nursing, Oregon Health & Science University, Portland, Oregon
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  • David G. Simons MD,

    1. Department of Rehabilitation Medicine, Emory University, Atlanta, Georgia
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    • Deceased.

  • Susan J. Smith MD,

    1. Department of Medicine, Michigan State University College of Human Medicine, East Lansing, Michigan
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  • Sunil Nagpal MD,

    1. Department of Medicine, Michigan State University College of Human Medicine, East Lansing, Michigan
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  • Donald E. Deering PhD

    1. NeuroHealth Associates, Rochester, Michigan, USA
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  • Conflict of Interest Statement: The lead author (JBH) has an intellectual property interest in the signal modulation method of the technique studied and is a shareholder in the Cerephex Corporation, which was founded after completion of this work to explore developing the technology for commercialization. No other authors have any potential conflicts of interest. None of the investigators received any compensation for their involvement in the study.

  • Funding: Funding for this research was provided by the McLaren Foundation and Kettering University (both of Flint, Michigan, USA). Neither agency played any active role in the design or execution of the study, nor do they have any financial interest in the work or the technology involved.

  • Trial Registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01180244.

Jeffrey B. Hargrove, PhD, Kettering University, 1700 University Avenue, Flint, MI 48504-6214, USA. Tel: 810-762-7437; Fax: 810-762-7860; E-mail: jhargrov@kettering.edu.

Abstract

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.

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