Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator:	University of Washington
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00524420

Purpose

While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of time, chronic pain persists and can continue for months and even years. Repetitive transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the brain and can affect brain activity. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing chronic widespread pain in women.

Condition	Intervention	Phase
Fibromyalgia Chronic Pain Depression	Device: rTMS Device: Sham rTMS	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Widespread Pain (CWP)

Resource links provided by NLM:

MedlinePlus related topics: Depression Fatigue Fibromyalgia

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Gracely Box Intensity Rating Scale [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hamilton Depression Rating Scale [ Time Frame: Measured weekly ] [ Designated as safety issue: Yes ]
Gracely Box Unpleasantness Scale [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]
Neuropsychological testing [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]
Audiometry [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	44
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active rTMS	Device: rTMS 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex Other Name: Neuronetics 2100 CRS rTMS System
Sham Comparator: Sham rTMS	Device: Sham rTMS 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS Other Name: Neuronetics 2100 rTMS and James Long Integrated Sham System

Detailed Description:

Chronic widespread pain is characterized by musculoskeletal pain that lasts for at least 3 months, pain above and below the waist, pain on both the right and left sides, and pain in the head, neck, spine, or back. In addition to fatigue, chronic widespread pain is a hallmark feature of fibromyalgia. Significant physical and emotional effects usually accompany chronic widespread pain and fibromyalgia, making the development of effective treatments a priority. rTMS involves a neurophysiologic technique that directs a current into the brain by using a magnetic field to pass the scalp and skull safely and painlessly. Stimuli are applied to the same brain area several times per second during several consecutive seconds. rTMS has been found to be effective for treating certain types of chronic pain. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing bodily pain associated with chronic widespread pain and/or fibromyalgia in women.

Participants in this study will undergo a diagnostic interview, physical and neurological exam, electrocardiogram, magnetic resonance imaging, and blood and urine collection for screening purposes. Eligible participants will then be randomly assigned to receive either rTMS treatment or sham rTMS treatment. One-hour daily treatment sessions will occur over 15 days. After every five treatment sessions, participants will be interviewed about their pain and depression symptoms, and they will fill out questionnaires about pain, depression, fatigue, sleep, and exercise. Participants will also undergo pain threshold and tolerance testing of their right thumb. On a daily basis, participants will rate their level of pain using a 0 to 20 scale. Follow-up evaluations will occur 1, 4, and 12 weeks after treatment and will include a repeat interview and testing. After the follow-up evaluations, any participants who did not respond to the sham treatment will be offered a series of 15 real rTMS treatment sessions.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of chronic widespread pain as defined by the 1990 American College of Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain above and below the waist; pain on both right and left sides; pain at one axial site (e.g., head, neck, spine, or back)
Willing to remain on a stable medical regimen during the entire 6-week course of Phase 1 treatment and 8 weeks prior to rTMS treatment
Willing to undergo random assignment and able to attend treatment sessions
Willing to remain on a stable psychotherapy regimen if currently receiving psychotherapy that has been ongoing for at least 3 months prior to study entry

Exclusion Criteria:

Unable to maintain treatment as usual at stable doses for any medical or psychiatric conditions for 8 weeks prior to and during the study
Another medical condition associated with significant pain (e.g., diabetic neuropathy, systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative joint disease)
Any condition that might increase the risk of seizures from TMS
History of a seizure disorder or family history of a seizure disorder
Previous use of TMS
Involvement in litigation or disability that is related to fibromyalgia, chronic widespread pain, or depression
Current use of proconvulsant medications (e.g., bupropion)
Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g., aneurysm clips, pacemakers, neurostimulators)
History of head injury associated with loss of consciousness for more than 15 minutes, brain surgery, or lithium toxicity
History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic disorder, or post-traumatic stress disorder
Current substance abuse or dependence
Active suicidal intent or plan
Severe claustrophobia that would prevent MRI
Major depression with psychotic features or a current major depressive episode lasting longer than 5 years
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524420

Contacts

Contact: Chandra D. Wajdik, BS

206-744-2436

cwajdik@u.washington.edu

Locations

United States, Washington
Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: David H. Avery, MD
Sub-Investigator: Dedra Buchwald, MD

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

University of Washington

Investigators

Principal Investigator:

David H. Avery, MD

University of Washington

More Information

Additional Information:

Click here for information on University of Washington research studies that are seeking volunteers This link exits the ClinicalTrials.gov site

Click here for the Neuronetics, Inc. Homepage This link exits the ClinicalTrials.gov site

Publications:

Avery DH, Holtzheimer PE 3rd, Fawaz W, Russo J, Neumaier J, Dunner DL, Haynor DR, Claypoole KH, Wajdik C, Roy-Byrne P. Transcranial magnetic stimulation reduces pain in patients with major depression: a sham-controlled study. J Nerv Ment Dis. 2007 May;195(5):378-81.

Responsible Party:	David H. Avery, MD, University of Washington
ClinicalTrials.gov Identifier:	NCT00524420 History of Changes
Other Study ID Numbers:	R21 AR053963, 1 R21 AR 053963-01, 06-2407-D 01
Study First Received:	August 30, 2007
Last Updated:	September 29, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Pain
Fatigue
Chronic Fatigue Syndrome

Chronic Fatigue-Fibromyalgia Syndrome
Depression
Major Depressive Disorder

Additional relevant MeSH terms:

Depression
Depressive Disorder
Fibromyalgia
Myofascial Pain Syndromes
Behavioral Symptoms
Mood Disorders

Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012