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

NCT01180244 | Completed Results

• 1 other identifier: 113
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; noninvasive; electrical; cortical; stimulation; pain; brain; tender point

Outcome Measures

Primary Outcomes (1)

• Change in Tender Point Pain Threshold

  Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm\^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of "less pain" sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome).

  Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

Secondary Outcomes (4)

• Change in Number of Positive Tender Points

  Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

• Change in Fibromyalgia Impact Questionnaire Overall Score

  Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

• Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale

  Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

• Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale

  Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device

Device: Noninvasive cortical electrical stimulation

Placebo group

PLACEBO COMPARATOR

Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device

Device: Sham treatment

Interventions

Noninvasive cortical electrical stimulation DEVICE

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.

Also known as: NeuroPoint

Active treatment

Sham treatment DEVICE

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.

Also known as: NeuroPoint

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McLaren Regional Medical Center: lead
• Kettering University: collaborator

Study Sites (1)

McLaren Regional Medical Center

Flint, Michigan, 48532, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jeffrey B. Hargrove
• Organization: Department of Mechanical Engineering, Kettering University

jhargrov@kettering.edu

Study Officials

• Jeffrey B Hargrove, PhD

  Kettering University

  PRINCIPAL INVESTIGATOR

• Susan J Smith, MD

  McLaren Regional Medical Center

  PRINCIPAL INVESTIGATOR

• Sunil Nagpal, MD

  McLaren Regional Medical Center

  PRINCIPAL INVESTIGATOR

• David G Simons, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 12, 2010
• Study Start: January 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 9, 2014
• Results First Posted: May 30, 2014

Record last verified: 2014-05

Locations

US (1)