Fibromyalgia (FM) is a common and disabling disorder. Currently, no single treatment has been found to be totally effective for all who have FM. The University of Washington’s Fibromyalgia Research Program is currently conducting a study to compare the benefits of combining pharmacological and behavioral health treatments for FM. This is a randomized control study that involves a combination of a drug treatment, behavioral health treatment, and placebo controls. Participants will be randomly assigned to a treatment (like flipping a coin). 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-Behavioral 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 + Cognitive Behavioral Therapy,
(2) Tramadol + Health Education,
(3) Placebo + Cognitive Behavioral Therapy,
(4) Placebo + Health Education.
The primary purpose of this study is to compare the benefits of the 4 combinations listed.
Participation in the study will require 13 visits over the course of 15 weeks, as well as a follow-up visit 6 months after treatment is completed. Participants may receive up to $300 for completion of the entire study.
Males or females, age 21-70 with a diagnosis of Fibromyalgia.
Currently have a primary healthcare provider
Not taken Tramadol in the past 6 months
No regular use of opiod medication (fewer than 10 tablets per month)
Fluent in English
There are some additional requirements that may exclude you from the study.
If you or someone you know may be interested in participating in this study, please contact the Fibromyalgia Research Program at (206)221-1737 or [email protected] (we cannot guarantee the confidentiality of any information sent by email).