Propranolol for Treating Fibromyalgia Pain

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 1

Conditions: Fibromyalgia Pain

Treatments: Drug: Propranolol 2; Drug: Placebo; Drug: Propranolol 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03029845

00084875

Details and patient eligibility

About

The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.

Full description

The main purpose of this study is to collect pilot feasibility study data for the use of low dose propranolol for helping treat fibromyalgia. The investigators plan to compare 20mg twice a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. The design is a 3 arm, double blind randomized control trial. The investigators will also test ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia.

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

Enrollment: 15 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR) FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).

Exclusion criteria

• 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
  • Participation in exercise or psychological treatment studies in the past 2 years
  • 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 55 bpm)
  • Resting diastolic BP < 55 mmHG or systolic BP<100 mmHG
  • ECG showing prolonged PR interval > .2 sec
  • ECG showing irregular PR interval
  • ECG showing incongruence between P wave and QRS

• Medication Criteria

  • Allergy or intolerance of beta blockers

  • Current use of the following drugs:

    • Antihypertensive drugs
    • Neuroleptics
    • Monoamine oxidase inhibitors
    • Tizanidine
    • Amphetamine-based medications
    • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

propranolol 1

Active Comparator group

Description:

20 mg propranolol twice a day

Treatment:

Drug: Propranolol 1

propranolol 2

Active Comparator group

Description:

10 mg propranolol twice a day

Treatment:

Drug: Propranolol 2

Placebo

Placebo Comparator group

Description:

Placebo twice a day

Treatment:

Drug: Placebo