rTMS for the Treatment of Chronic Pain in GW1 Veterans
This study was designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the first Gulf War (GW1) who often suffer from chronic pain problems.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||rTMS for the Treatment of Chronic Pain in GW1 Veterans|
- McGill Pain Questionnaire [ Time Frame: One Month ] [ Designated as safety issue: No ]The McGill Pain Questionnaire (MPQ) is a well-validated measure with extensive clinical research use (Melzack, 1987). Patients rate their pain in sensory terms (e.g., sharp or stabbing) and affective terms (i.e. sickening or fearful), with 15 total descriptors. Each item is rated on a 4-point scale that ranges from none to severe. The MPQ also has a single item for pain intensity and for rating the overall pain experience.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.
Repetitive Transcranial Magnetic Stimulation
Placebo Comparator: Sham rTMS
Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.
Device: Sham device
Placebo Device that simulates active rTMS treatment
A number of studies have been conducted on the health of veterans deployed to Iraq during GW1. The focus of these studies has been primarily to define the nature of symptoms and symptom clusters and to determine if evidence supports the definition of a new unique illness. Most noteworthy is the "Iowa Study", a cross-sectional study of 3,695 veterans from Iowa consisting of those who were and were not deployed in GW1. In telephone interviews the Gulf War deployed veterans reported approximately twice the number of symptoms compared to those who were not deployed.
The often ambiguous and seemingly treatment resistant symptoms presented by GW1 veterans represent a challenge to the Veteran's Affairs Health Care System on two fronts; efficacy in treatment and cost. In particular, unlike most medical conditions which can be diagnosed by objective medical findings, pain is a subjective experience (International Association for the Study of Pain, 1994). Therefore the investigators propose to engage in a clinical trial of rTMS in chronic pain, defined for the study as fibromyalgia type pain, which occurs in the context of multiple medical symptoms in the GW1 population. The symptom category approach will be applied with the restriction that enrolled GWI diagnosed patients will have symptoms of chronic pain as outlined in the musculoskeletal category and defined by fibromyalgia type pain and at least two additional symptoms from the mood-cognition and/or fatigue categories. The diagnostic criteria for fibromyalgia best represents the wide spread pain, joint pain, joint stiffness, numbness and tingling, and muscle pain which characterizes veteran pain complaints associated with Gulf War Illness (GWI).
|Contact: Janet A Balwin, BA||(650) 852-3233|
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA||Recruiting|
|Palo Alto, California, United States, 94304-1290|
|Contact: Janet A Balwin, BA 650-852-3233|
|Principal Investigator: John W. Ashford, MD PhD|
|Principal Investigator:||John W. Ashford, MD PhD||VA Palo Alto Health Care System, Palo Alto, CA|