Combined Behavioral and Analgesic Trial for Fibromyalgia
NCT ID: NCT01598753
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
134 participants
INTERVENTIONAL
2012-05-31
2018-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Tramadol
Tramadol
50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
Minimum accepted dose of 200mg per day
Placebo
Placebo
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
Cognitive Behavior Therapy for FM
Cognitive Behavior Therapy for FM
Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
Health Education
Health Education
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Interventions
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Tramadol
50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
Minimum accepted dose of 200mg per day
Placebo
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
Cognitive Behavior Therapy for FM
Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
Health Education
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Fibromyalgia
* Current primary care physician
* Fluent in English
Exclusion Criteria
* 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
21 Years
70 Years
ALL
No
Sponsors
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University of Washington
OTHER
Responsible Party
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Dennis Turk
Professor, Anesthesiology
Locations
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University of Rochester
Rochester, New York, United States
University of Washington
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00001259
Identifier Type: -
Identifier Source: org_study_id
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