The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether persons treated with a low-intensity,
      noninvasive form of cortical electrical stimulation experience a reduction in symptoms of
      fibromyalgia different than persons receiving a sham treatment. Outcome measures include
      reduction in patient pain levels and improvement in sleep measures.
    

Detailed description: 
      There is increasing acceptance that pain in fibromyalgia is a result of dysfunctional sensory
      processing in the spinal cord and brain. Electrical cortical stimulation is a device-based
      form of therapy that is increasingly being considered as an adjuvant to current medical
      modalities for the treatment of chronic pain conditions such as fibromyalgia. The
      investigators propose that stimulation of cortical areas believed to be involved in
      dysfunctional sensory processing may have a beneficial influence on fibromyalgia symptoms.

      The aim of this randomized double blind, placebo controlled study is to evaluate the
      efficacy, safety, and tolerability of noninvasive cortical stimulation in the management of
      fibromyalgia symptoms. More specifically, an active treatment group of subjects will receive
      the study's cortical stimulation protocol twice a week for 11 weeks and will be evaluated
      within 14 days following end of treatment, for a total timeframe of 13 weeks. In comparison,
      a similar group of subjects will receive the same treatment protocol without the actual
      stimulation signal being applied. The signal utilized is a modulated form that permits very
      low-intensity signals to pass through outer tissues with less attenuation due to tissue
      impedance. The signals are of a sufficiently low strength that they are below the level of
      perception. Hence subjects cannot feel the signal, and are therefore blinded to treatment
      arm. Investigators and clinical staff are also blinded. Outcome measures include
      post-treatment to baseline changes in tender points, sleep characteristics as measured by
      visual analog scales, and outcomes instruments including the Fibromyalgia Impact
      Questionnaire.
    

Intervention name(s): Noninvasive cortical electrical stimulation; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.; Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
Other intervention name(s): NeuroPoint; NeuroPoint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibromyalgia; noninvasive; electrical; cortical; stimulation; pain; brain; tender point