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The funding ended.
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The purpose of the study to evaluate the feasibility of using low dose propranolol for people 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propranolol 1 | Active Comparator | 20 mg propranolol twice a day |
|
| propranolol 2 | Active Comparator | 10 mg propranolol twice a day |
|
| Placebo | Placebo Comparator | Placebo twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol 1 | Drug | Participants will take 20 mg propranolol twice a day for 2 weeks |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
General Health Criteria:
Cardiovascular Criteria:
Medication Criteria
Allergy or intolerance of beta blockers
Current use of the following drugs:
Participants may be included after minimum of 4 weeks of physician prescribed termination of these drugs
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| Name | Affiliation | Role |
|---|---|---|
| Akiko Okifuji, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| C023656 | propranolol mustard |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Propranolol 2 | Drug | Participants will take 10 mg propranolol twice a day for 2 weeks |
|
|
| Placebo | Drug | Participants will take placebo twice a day for 2 weeks |
|
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |