N/A N=91 Randomized Quadruple-blind Treatment

The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT01180244 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Change in Tender Point Pain Threshold — 19.6; -3.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Noninvasive cortical electrical stimulation (Device); Sham treatment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: McLaren Regional Medical Center
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Tender Point Pain Threshold	19.6; -3.2	—
SECONDARY Change in Number of Positive Tender Points	-7.4; -0.2	—
SECONDARY Change in Fibromyalgia Impact Questionnaire Overall Score	-15.5; -5.6	—
SECONDARY Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale	-2.0; -0.6	—
SECONDARY Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale	-2.1; -0.7	—

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.

Eligibility Criteria

Inclusion Criteria

Age 18 through 65 years
An ability to read and comprehend English
Completion of a minimum of grade 8 education
Diagnosis of fibromyalgia in 1999 or earlier, by a rheumatologist or appropriate specialist, and currently meeting the American College of Rheumatology 1990 criteria
Symptoms for at least 48 months with no recent remission of symptoms to any degree

Exclusion Criteria

Developmental disabilities, or significant psychological disorder (except depression and anxiety disorders) for which treatment has become necessary
A history of chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's Disease, multiple sclerosis, hepatitis, history of meningo-encephalitis, polio, seizures, or metastatic cancer
Current pregnancy, or plans to become pregnant during the study period.
Any other condition deemed to pose a risk to the patient at the discretion of the investigators
Exposure to other neurostimulation systems, or electroconvulsive therapy
Any implantable electronic device
Any present or previous litigation regarding their physical condition

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Data sourced from ClinicalTrials.gov (NCT01180244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.