Propranolol for Treating Fibromyalgia Pain

Study Overview
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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.

Official Title
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Propranolol for Treating Fibromyalgia Pain: Pilot Study

Conditions
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Fibromyalgia Pain

Intervention / Treatment
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* Drug: Propranolol 1
* Drug: Propranolol 2
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propranolol 1<br>20 mg propranolol twice a day | Drug: Propranolol 1<br>* Participants will take 20 mg propranolol twice a day for 2 weeks<br>* Other names: 20 mg propranolol;|
| Active Comparator: propranolol 2<br>10 mg propranolol twice a day | Drug: Propranolol 2<br>* Participants will take 10 mg propranolol twice a day for 2 weeks<br>* Other names: 10 mg propranolol;|
| Placebo Comparator: Placebo<br>Placebo twice a day | Drug: Placebo<br>* Participants will take placebo twice a day for 2 weeks<br>|

What is the study measuring?
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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) |