Combined Behavioral and Analgesic Trial for Fibromyalgia

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Tramadol; Drug: Placebo; Behavioral: Cognitive Behavior Therapy for FM; Behavioral: Health Education

• Registration Number: NCT01598753
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-15
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-06
• Results First Submitted: 2019-06-03
• Results First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-24
• Results First Posted: 2019-06-26
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Tramadol	Tramadol	-
Placebo	Placebo	-
Cognitive Behavior Therapy for FM	Cognitive Behavior Therapy for FM	-
Health Education	Health Education	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function	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."

Trial Locations

Locations (2)

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Washington; 🇺🇸 Seattle, Washington, United States