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Propranolol for Treating Fibromyalgia Pain

Primary Purpose

Fibromyalgia Pain

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Propranolol 1

Propranolol 2

Placebo

About this trial

This is an interventional treatment trial for Fibromyalgia Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

propranolol 1

propranolol 2

Placebo

Arm Description

20 mg propranolol twice a day

10 mg propranolol twice a day

Placebo twice a day

Outcomes

Primary Outcome Measures

Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)

Changes in clinical pain will be measured

Secondary Outcome Measures

Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue

Changes in fibromyalgia-related symptoms

Full Information

NCT ID

NCT03029845

First Posted

January 18, 2017

Last Updated

August 21, 2018

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT03029845

Brief Title

Propranolol for Treating Fibromyalgia Pain

Official Title

Propranolol for Treating Fibromyalgia Pain: Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

The funding ended.

Study Start Date

January 2017 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

propranolol 1

Arm Type

Active Comparator

Arm Description

20 mg propranolol twice a day

Arm Title

propranolol 2

Arm Type

Active Comparator

Arm Description

10 mg propranolol twice a day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo twice a day

Intervention Type

Drug

Intervention Name(s)

Propranolol 1

Other Intervention Name(s)

20 mg propranolol

Intervention Description

Participants will take 20 mg propranolol twice a day for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Propranolol 2

Other Intervention Name(s)

10 mg propranolol

Intervention Description

Participants will take 10 mg propranolol twice a day for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will take placebo twice a day for 2 weeks

Primary Outcome Measure Information:

Title

Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)

Description

Changes in clinical pain will be measured

Time Frame

Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)

Secondary Outcome Measure Information:

Title

Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue

Description

Changes in fibromyalgia-related symptoms

Time Frame

Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akiko Okifuji, PhD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Propranolol for Treating Fibromyalgia Pain

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