Clinical trial NCT01180244: The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
Official title: The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
noninvasive
electrical
cortical
stimulation
pain
brain
tender point
Lead sponsor: McLaren Regional Medical Center
Sponsor class: OTHER
Collaborators: name: Kettering University
First posted: 2010-08-12
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change in Tender Point Pain Threshold
timeFrame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Secondary outcomes:
measure: Change in Number of Positive Tender Points
timeFrame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
measure: Change in Fibromyalgia Impact Questionnaire Overall Score
timeFrame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
measure: Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale
timeFrame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
measure: Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale
timeFrame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Other outcomes:
Locations:
city: Flint
country: United States
facility: McLaren Regional Medical Center
state: Michigan
Study officials:
affiliation: Kettering University
name: Jeffrey B Hargrove, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McLaren Regional Medical Center
name: Susan J Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McLaren Regional Medical Center
name: Sunil Nagpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: David G Simons, MD
role: PRINCIPAL_INVESTIGATOR
References: