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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.
 
ClinicalTrials.gov Identifier: NCT01598753
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
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 : 134 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. Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function [ Time Frame: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline). ]
    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."



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01598753


Locations
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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:
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Responsible Party: Dennis Turk, Professor, Anesthesiology, University of Washington
ClinicalTrials.gov Identifier: NCT01598753    
Other Study ID Numbers: STUDY00001259
First Posted: May 15, 2012    Key Record Dates
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents