Combined Behavioral and Analgesic Trial for Fibromyalgia

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.