Fibromyalgia Clinical Trial
— COMBAT-FMOfficial title:
Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With Fibromyalgia
Verified date | June 2019 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized control study that involves a combination of a drug treatment,
behavioral health, and placebo controls.
Some participants will receive a medication approved by the Food and Drug Administration for
treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive
an inactive pill, called a placebo. There will also be 2 different types of behavioral health
treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have
been recommended for the treatment of patients with FM by the American Pain Society.
There are 4 possible study treatment combinations:
1. Tramadol + CBT,
2. Tramadol + HE,
3. Placebo + CBT,
4. Placebo + HE.
Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there
have been no studies that have evaluated the combination of medication and a behavioral
health treatment. The primary purpose of this study is to compare the benefits of the 4
combinations listed.
Status | Completed |
Enrollment | 134 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Males and Females 21-70 - Diagnosis of Fibromyalgia - Current primary care physician - Fluent in English Exclusion Criteria: - Rheumatologic disorders - Drug and alcohol abuse in the past year - Psychiatric hospitalization in the past 6 months - Current use of Tramadol - Certain antidepressant and other pain medications |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled "responders." | Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline). |
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