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Trial record 5 of 104 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Propranolol for Treating Fibromyalgia Pain

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Akiko Okifuji, University of Utah
Sponsor:
Information provided by (Responsible Party):
Akiko Okifuji, University of Utah
ClinicalTrials.gov Identifier:
NCT03029845
First received: January 18, 2017
Last updated: July 28, 2017
Last verified: July 2017
  Purpose
The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.

Condition Intervention Phase
Fibromyalgia Pain Drug: Propranolol 1 Drug: Propranolol 2 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Propranolol for Treating Fibromyalgia Pain: Pilot Study

Resource links provided by NLM:


Further study details as provided by Akiko Okifuji, University of Utah:

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


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


Estimated Enrollment: 30
Study Start Date: January 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 10 mg propranolol
Placebo Comparator: Placebo
Placebo twice a day
Drug: Placebo
Participants will take placebo twice a day for 2 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03029845

Contacts
Contact: Yuri Kida, MSW 801-585-7697 yuri.kida@hsc.utah.edu
Contact: Reiko Mitsunaga, RN 801-585-7695 reiko.mitsunaga@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Yuri Kida, MSW    801-585-7697    yuri.kida@hsc.utah.edu   
Contact: Reiko Mitsunaga, RN    801-585-7695    reiko.mitsunaga@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Akiko Okifuji, PhD University of Utah
  More Information

Responsible Party: Akiko Okifuji, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03029845     History of Changes
Other Study ID Numbers: 00084875
Study First Received: January 18, 2017
Last Updated: July 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 23, 2017