Propranolol for Treating Fibromyalgia Pain: Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
研究概览
简要总结
The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
propranolol 1
20 mg propranolol twice a day
干预措施: Propranolol 1 (Drug)
propranolol 2
10 mg propranolol twice a day
干预措施: Propranolol 2 (Drug)
Placebo
Placebo twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
时间窗: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Changes in clinical pain will be measured
次要结局
- Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue(Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial))
研究者
Akiko Okifuji
Professor
University of Utah