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Propranolol for Treating Fibromyalgia Pain

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ClinicalTrials.gov Identifier: NCT03029845
Recruitment Status : Terminated (The funding ended.)
First Posted : January 24, 2017
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Akiko Okifuji, University of Utah

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Pain Drug: Propranolol 1 Drug: Propranolol 2 Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : January 2017
Actual Primary Completion Date : April 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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 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




Primary Outcome Measures :
  1. 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 :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029845


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Akiko Okifuji, PhD University of Utah

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Responsible Party: Akiko Okifuji, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03029845     History of Changes
Other Study ID Numbers: 00084875
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Propranolol
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
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