Clinical trial NCT03029845: Propranolol for Treating Fibromyalgia Pain
Official title: Propranolol for Treating Fibromyalgia Pain: Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fibromyalgia Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
timeFrame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Secondary outcomes:
measure: Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue
timeFrame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Akiko Okifuji, PhD
role: PRINCIPAL_INVESTIGATOR
References: