Pilot Study of Propranolol on Fibromyalgia

(closed to new enrollment)

Overview

Fibromyalgia (FMS) is a common chronic pain syndrome that is disabling to patients and costly to the society. FMS is devastating to the individual’s quality of life and family members. Despite intense research, what causes fibromyalgia is poorly understood and no single therapy is found to be beneficial to all patients.

The primary goal of this study is to collect pilot data in order to evaluate the effect of low dose blood pressure medication, propranolol, on fibromyalgia symptoms using two different doses. This study is funded by the Department of Anesthesiology at the University of Utah. All participants will be screened for eligibility and those who complete the entire study will be compensated for their time.

Participants will attend three separate study visits. During the initial visit, participants will undergo a tender point analysis, fill out several questionnaires assessing symptoms related to quality of life and FMS, have an electrocardiogram, and be shown how to take their blood pressure with the device provided. At the 2 ^nd visit, participants will return their blood pressure log and received either 10 mg, 20 mg of propranolol or placebo medication and be asked to take it twice a day for two weeks. They will continue to monitor their blood pressure for the next two week and will receive a new blood pressure log at this visit. At the 3 ^rd visit, participants will fill out the same questionnaires they completed at the initial visit, have another electrocardiogram and return the blood pressure device they received at the beginning of the study.

Contact

Principal Investigator: Akiko Okifuji, PhD
Department: Pain Research Center
Co-Investigator: Brad Hare, M.D.

For more information about whether you qualify to participate in this trial, please contact the study coordinator(s) listed at the below.

Contact Information

Name: Yuri Kida
Phone: (801) 585-7697
Email: pain.research@hsc.utah.edu

Name: Reiko Mitsunaga, RN
Phone: (801) 585-7695
Email: pain.research@hsc.utah.edu

Inclusion Criteria

Subjects must meet all of the following criteria in order to be eligible to enroll in the study.

1. Formally diagnosed with Fibromyalgia Syndrome by a healthcare provider.
2. Ages 18-65.
3. Able to understand fully and comply with all protocol requirements.
4. Must sign an informed consent form and privacy authorization form before any study procedures are initiated.
5. Must not engage in active exercise.
   1. No aerobic activities including cycling, jogging, climbing, rowing or muscle strengthening activity for more than 120 minutes per week.
6. Able to take medication in tablet form.

Exclusion Criteria

Subjects may not enroll in the study if any of the following conditions apply:

General Health Criteria

1. Uncontrolled or unstable illness (self-reported or physician diagnosed).
2. Pregnancy or planning to be pregnant in the next year.
3. Asthma requiring medication treatment including inhaler.
4. Type I or Type II diabetes mellitus requiring medical therapy that can lead to hypoglycemia (even if stabilized by therapy).
5. Having acute or neuropathic pain.
6. Participation in any psychological treatment or exercise studies in the past 2 years.
7. Having known serious psychopathology.
   1. Psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year, history of recreational IV drug use, substance abuse history in the past year.

Cardiovascular Criteria

1. Having known cardiovascular diseases (self-reported or physician diagnosed).
   1. Using a pacemaker.
   2. Having bradycardia (resting heart rate less than 55 bpm).
   3. Resting diastolic blood pressure (bottom number) less than 55 mmHg.
   4. Resting systolic blood pressure (top number) less than 100 mmHg.

Medication Criteria

1. Allergy or intolerance of beta blockers.
2. Current use of any of the following drugs:
3. Antihypertensive drugs
   1. i.e. lisinopril, losartan, amlodipine, hydrochlorothiazide, atenolol, lasix
4. Neuroleptics
   1. i.e. risperidone (Risperdal), aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel)
5. Monoamine oxidase inhibitors
   1. i.e. phenelzine, selegiline, tranylcypromine
6. Tizanidine (zanaflex)
7. Stimulants
   1. i.e. amphetamines [Adderall], methylphenidate [Ritalin], modafinil [Provigil]
8. Bupropion (Wellbutrin, zyban)
9. Mirtazapine (Remeron)
10. Tricyclics: Daily dose greater than 75 mg amitriptyline or equivalent.
    1. i.e. desipramine (norpramin), doxepin
11. Benzodiazapine: Daily dose greater than 5 mg diazepam (Valium) or equivalent as listed below:
    1. 0.25 mg alprazolam (Xanax)
    2. 0.5 mg lorazepam (Ativan)
12. Asthmatic medication, including inhaler.
    1. i.e. singulair, prednisone, Advair, symbicort, albuterol