Combined Behavioral and Analgesic Trial for Fibromyalgia
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 11/3/2018 |
| Start Date: | May 2012 |
| End Date: | July 31, 2018 |
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
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.
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.
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
We found this trial at
2
sites
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Dennis Turk, PhD
Phone: 206-221-1737
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Robert Dworkin, PhD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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