Phase 2
N=19
Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain
Fibromyalgia · Chronic Pain · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00524420 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Gracely Box Intensity Rating Scale — 13.18; 14.43; 10.64; 13.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rTMS (Device); Sham rTMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gracely Box Intensity Rating Scale |
13.18; 14.43; 10.64; 13.00; 10.27; 11.29 | — |
| SECONDARY Gracely Box Unpleasantness Scale |
9.91; 12.57; 8.73; 11.86; 9.00; 10.43 | — |
| SECONDARY Hamilton Depression Rating Scale |
14.64; 14.71; 11.18; 15.43; 9.09; 11.86 | — |
| SECONDARY Adverse Events |
36; 35 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00524420). 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.