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

[mads]

Hi Guys,

This study is currently recruiting participants. Good luck!

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

ClinicalTrials.gov Identifier:

NCT01598753

Purpose

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	Intervention	Phase 3
Fibromyalgia	Drug: Tramadol Drug: Placebo Behavioral: Cognitive Behavior Therapy for FM Behavioral: Health Education

Primary Outcome Measures:

• Change in mean pain severity derived from 5-days of daily pain diaries and change in physical function assessed from the Fibromyalgia Impact Questionnaire-Revised (FIQ-R). [ Time Frame: Baseline is one week prior to drug titration. Post treatment is assessed the week following final treatment ] [ Designated as safety issue: No ]
  The primary outcome is the change in pain severity measured by the average of 5-days of daily pain diaries assessed just prior to and at the end of treatment.

Estimated Enrollment:	250
Study Start Date:	May 2012
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
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

  Contact: Caitlin Sheffels	206-■■■■■■■■	■■■■■■■■■■■■■

  
  
  Locations
• United States, New York
  University of Rochester	Recruiting
  Rochester, New York, United States
  Contact: Robert Dworkin, PhD ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■
  Principal Investigator: Robert Dworkin, PhD
  United States, Washington
  University of Washington	Recruiting
  Seattle, Washington, United States, 98195
  Contact: Caitlin M Sheffels, BA 206-■■■■■■■■ ■■■■■■■■■■■■■
  Principal Investigator: Dennis Turk, PhD

  Sponsors and Collaborators
  University of Washington

[purplebutterfly]

There is also a clinical trials site on the main page.

[Petunia_Girl]

Not only might it be outdated, but we would also have to get off whatever we are on for pain, and then either be treated with Tramadol plus either cognitive behavior therapy or health education, or else get a placebo. Now, sometimes that's not a problem, for some medical issues. But in our case, I just can't see it. Cognitive behavior therapy seems to consist of giving yourself positive messages about yourself and how your sickness doesn't define you. Great, right, whatever. And Health Education??? Sorry but this study doesn't really impress me, but that's only my opinion. And heck to the NO for getting a placebo aka a dummy pill.