Propranolol for Treating Fibromyalgia Pain

Propranolol for Treating Fibromyalgia Pain: Pilot Study

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

Study Overview

• Status: Terminated
• Conditions: Fibromyalgia Pain
• Intervention / Treatment: Drug: Propranolol 1; Drug: Propranolol 2; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propranolol 1; 20 mg propranolol twice a day	Drug: Propranolol 1; Participants will take 20 mg propranolol twice a day for 2 weeks; Other Names: 20 mg propranolol
Active Comparator: propranolol 2; 10 mg propranolol twice a day	Drug: Propranolol 2; Participants will take 10 mg propranolol twice a day for 2 weeks; Other Names: 10 mg propranolol
Placebo Comparator: Placebo; Placebo twice a day	Drug: Placebo; Participants will take placebo twice a day for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)	Changes in clinical pain will be measured	Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue	Changes in fibromyalgia-related symptoms	Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Akiko Okifuji, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 00084875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No