Preparation Program for Treating Fibromyaliga

You may be eligible to participate in the study if you:

1. Are male or female between 21 to 65 years of age
2. Do not engage in vigorous activities for greater than 30 minutes a week
3. Are currently not pregnant and are not planning to become pregnant within the next year
4. Are currently not planning to have surgery within the next year
5. If your resting diastolic blood pressure is not >115 mm Hg/ and systolic blood pressure is not >200 mm Hg
6. Do not have any major heart, lung or vessel disease
7. Do not have a serious progressive medical condition such as Cancer, Parkinson's Disease, Multiple Sclerosis, Muscular Dystrophy, Amyotrophic Lateral Sclerosis, Congestive heart failure, liver or renal failure, Polycystic Ovarian Disease, etc.
8. Are not currently taking 75 mg or greater of amitriptyline
9. Do not have any other pain disorder such as Rheumatoid Arthritis, neuropathic pain such as Diabetes Neuropathy and Peripheral Neuropathy, Systemic Lupus Erythematosus, Polymalgia Rheumatica, Osetoarthritis (degenerative joint disease), Myofascial Pain Syndrome, neurogenic pain disorder such as Trigeminal Neuralgia, Reflux Sympathetic Dystrophy, Post Herpetic Neuralgia, etc.
10. Do not have a history of head injury or neurological illness
11. Have not been diagnosed with a learning disability or learning problem
12. Do not have a history of near downing
13. Do not have a history of non-IV substance abuse within the last 2 years, or a history of recreational IV drug use.
14. Have not attempted suicide or been admitted for psychiatric evaluation within the last year.
15. Have not had any substantial toxin or chemical exposure within five years of your Fibromyalgia onset.

Study Requirements:

1. You will be asked to visit the Pain Research Center to review the consent form and review eligibility criteria. Once you have agreed to participate in the study you will be asked to fill out some questionnaires and health history form. You will be asked to monitor various symptoms using a small hand held computer device called a Palm Pilot (which will be provided) for 7 days. You will also be asked to wear a wristwatch-like device to monitor your physical activities. This visit will take approximately 2 hours.
2. You will then need to visit our Pain Management Center 1 week later for a full comprehensive medical, physical and psychological examination. After the examination, if you meet the criteria to enroll in the study we will draw some blood for testing. You will then be set up for the treatment program. This visit will take approximately 4 hours.
3. Treatment program. The treatment is given in a group format of 2 1/2 hours a week for 10 consecutive weeks. It includes a combination of active physical therapy and behavioral therapy to help you better manage your Fibromyalgia symptoms.
4. At the conclusion of your treatment program you will be asked to return to the Pain Management Center for a post-treatment medical, physical and psychological examination similar to the one taken previous to the treatment. You will also be asked to fill out the questionnaires and monitor your symptoms again for 1 week using the Palm Pilot and wear the activity monitor watch-like device. This visit will take approximately 3 hours.
5. The Pain Research Center will call you once a month after you have finished your treatment program and ask you to rate a series of symptoms. This will take approximately 10 minutes each month.
6. Six months after you have finished the treatment program, we will ask you to come in for a 6-month follow-up evaluation similar to your post-treatment evaluation. Once again you will be asked to fill out the questionnaires and monitor your symptoms for 1 week using the Palm Pilot and wear the activity monitor watch-like device. This visit will take approximately 3 hours.
7. Twelve months after you have finished the treatment program we will send you out some questionnaires similar to the ones you filled out when you first enrolled in the study. We ask you fill them out and mail them back to us.
8. All comprehensive evaluations and treatment will be provided to you at no cost.

If you are interested in participating in this project and wonder whether you are eligible, or if you would like to learn more about the project, please call the number below.

Pain Research Center
Treatment Program for Fibromyaliga
Department of Anesthesiology
University of Utah
(801) 585-7697
pain.research@hsc.utah.edu