Propranolol for Treating Fibromyalgia Pain

NCT ID: NCT03029845

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Fibromyalgia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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propranolol 1

20 mg propranolol twice a day

Group Type ACTIVE_COMPARATOR

Propranolol 1

Intervention Type DRUG

Participants will take 20 mg propranolol twice a day for 2 weeks

propranolol 2

10 mg propranolol twice a day

Group Type ACTIVE_COMPARATOR

Propranolol 2

Intervention Type DRUG

Participants will take 10 mg propranolol twice a day for 2 weeks

Placebo

Placebo twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will take placebo twice a day for 2 weeks

Interventions

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Propranolol 1

Participants will take 20 mg propranolol twice a day for 2 weeks

Intervention Type DRUG

Propranolol 2

Participants will take 10 mg propranolol twice a day for 2 weeks

Intervention Type DRUG

Placebo

Participants will take placebo twice a day for 2 weeks

Intervention Type DRUG

Other Intervention Names

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20 mg propranolol 10 mg propranolol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Akiko Okifuji

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akiko Okifuji, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00084875

Identifier Type: -

Identifier Source: org_study_id

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