Propranolol for Treating Fibromyalgia Pain

Fibromyalgia Pain Clinical Trial

Official title:

Propranolol for Treating Fibromyalgia Pain: Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03029845
• Other study ID #: 00084875
• Status: Terminated
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Pain
• Myofascial Pain Syndromes

Intervention

Drug:
• Propranolol 1
Participants will take 20 mg propranolol twice a day for 2 weeks
• Propranolol 2
Participants will take 10 mg propranolol twice a day for 2 weeks
• Placebo
Participants will take placebo twice a day for 2 weeks

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)