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Combined Behavioral and Analgesic Trial for Fibromyalgia (COMBAT-FM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598753
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):
Dennis Turk, University of Washington

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Tramadol Drug: Placebo Behavioral: Cognitive Behavior Therapy for FM Behavioral: Health Education Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2012
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: Tramadol Drug: 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 Comparator: Placebo Drug: Placebo
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg

Active Comparator: Cognitive Behavior Therapy for FM Behavioral: 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.

Sham Comparator: Health Education Behavioral: Health Education
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia

Primary Outcome Measures :
  1. 30% improvement in daily diary pain intensity ratings or 20% improvement in the 9-item function subscale of the Fibromyalgia Impact Questionnaire Revised (FIQR). [ Time Frame: Baseline is one week prior to drug titration. Post treatment is assessed the week following final treatment ]
    The primary outcome is the change in pain severity measured by the average of 5-days of daily pain diaries, or a change in score of the function subscale of the FIQR, assessed just prior to and at the end of treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01598753

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United States, New York
University of Rochester
Rochester, New York, United States
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
  Study Documents (Full-Text)

Documents provided by Dennis Turk, University of Washington:
Study Protocol  [PDF] December 16, 2014
Statistical Analysis Plan  [PDF] October 29, 2018

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Responsible Party: Dennis Turk, Professor, Anesthesiology, University of Washington Identifier: NCT01598753     History of Changes
Other Study ID Numbers: STUDY00001259
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents