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

Study Description

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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

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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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

Contacts and Locations

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Locations

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

More Information

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

Additional relevant MeSH terms:

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