Propranolol for treating fibromyalgia pain: pilot

Principal Investigator: Akiko Okifuji
Keywords: fibromyalgia , drug trial Department: Anesthesiology
IRB Number: 00084875 Co Investigator: Alan Light
Specialty: Anesthesiology, Pain Management
Sub Specialties: Chronic Pain,
Recruitment Status: Recruiting

Contact Information

Yuri Kida
yuri.kida@hsc.utah.edu
801-585-7697

Brief Summary

The main aim of this study is to collect pilot feasibility study data for the use of low dose propranolol for helping treat fibromyalgia and determine the dose we can use for a future clinical trial study. We would like to compare 20mg twice a day dosage of propranolol (which were previously used) and 10mg twice a day dosage of propranolol to placebo. We would like to see if using 10g twice a day, instead of 20mg BID, will be feasible and reasonable. As this is a feasibility study for the future clinical trial, we will also test the recently acquired equipment, ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia, which is a measure of vagal tone.

Propranolol is not indicated to treat pain. However, the previous studies (see below) showed that low dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with chronic musculoskeltal pain. We are not aiming however to develop a new indication of the drug.

Light KC, Bragdon EE, Grewen KM, Brownley KA, Girdler SS, Maixner W. Adrenergic dysregulation and pain with and without acute beta-blockade in women with fibromyalgia and temporomandibular disorder. J Pain. May 2009;10(5):542-552

 Tchivileva IE, Lim PF, Smith SB, et al. Effect of catechol-O-methyltransferase polymorphism on response to propranolol therapy in chronic musculoskeletal pain: a randomized, double-blind, placebo-controlled, crossover pilot study. Pharmacogenet Genomics. Apr 2010;20(4):239-248

 

As this is a feasibility study for the future clinical trial, we will also test the recently acquired equipment, ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia, which is a measure of vagal tone.

Detailed Description

Propranolol is not indicated to treat pain. However, the previous studies (see below) showed that low dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with chronic musculoskeltal pain. We are not aiming however to develop a new indication of the drug. Light KC, Bragdon EE, Grewen KM, Brownley KA, Girdler SS, Maixner W. Adrenergic dysregulation and pain with and without acute beta-blockade in women with fibromyalgia and temporomandibular disorder. J Pain. May 2009;10(5):542-552 Tchivileva IE, Lim PF, Smith SB, et al. Effect of catechol-O-methyltransferase polymorphism on response to propranolol therapy in chronic musculoskeletal pain: a randomized, double-blind, placebo-controlled, crossover pilot study. Pharmacogenet Genomics. Apr 2010;20(4):239-248 As this is a feasibility study for the future clinical trial, we will also test the recently acquired equipment, ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia, which is a measure of vagal tone.

Inclusion Criteria

Inclusion:

Females with fibromyalgia (meeting 2010 American College of Rheumatology (ACR) FMS criteria) age 18-75 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).

This is a small pilot study that will help our future large clinical trial. The future trial will include the investigation of the gene expression in response to the treatment. Fibromyalgia is predominantly diagnosed in women and over 95% of the participants in our previous studies were females. This will make the investigation of gene expression tricky as we will not be able to collect enough male subjects to evaluate the sex difference. Having a small number of male participants thus will introduce worrisome confound. Given this, we decided to include only female subjects.

 

Exclusion Criteria

Exclusion:

General Health Criteria:

  • Uncontrolled/unstable illnesses (physician diagnosed, self-report)
  • Pregnancy or planning to be pregnant in the next year
  • Having Asthma requiring medication treatment including inhaler
  • Type I diabetes or Type II diabetes requiring medical therapy that can lead to hypoglycemia
  • Having acute pain or neuropathic pain
  • Having known serious psychopathology
    • 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:

  • Having known cardiovascular diseases (self-report, physician diagnosed)
  • Pacemaker
  • Bradycardia (resting heartrate of less than 55bpm)
  • Resting diastolic BP < 55mmHG or systolic BP<100mmHG
  • ECG showing prolonged PR interval > .20 sec
  • ECG showing irregular PR interval
  • ECG showing incongruence between P wave and QRS
  • ECG showing prolonged QT interval >.44 seconds

Medication Criteria

  • Allergy or intolerance of beta blockers
  • Current use of the following drugs
    • Antihypertensive drugs
    • Neuroleptics
    • Monoamine oxidase inhibitors
    • Tizanidine
    • Amphetamine-based medications (due to possible decrease effectiveness)
    • Bupropion
    • Mirtazapine
    • Tricyclics: daily dose greater than 75mg amitriptyline or equivalent
    • Benzodiazepine: daily dose greater than 5mg diazepam or equivalent
    • Asthmatic medicine, including inhaler
  • Participants may be included after minimum of 4 weeks of physician prescribed termination of these drugs