Propranolol for Treating Fibromyalgia Pain
Status: | Terminated |
---|---|
Conditions: | Fibromyalgia, Pain |
Therapuetic Areas: | Musculoskeletal, Rheumatology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/25/2018 |
Start Date: | January 2017 |
End Date: | July 2018 |
Propranolol for Treating Fibromyalgia Pain: Pilot Study
The purpose of the study to evaluate the feasibility of using low dose propranolol for people
with fibromyalgia.
with fibromyalgia.
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.
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.
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
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