Status:
COMPLETED
Neurohormonal Benefits of Exercise in Fibromyalgia and PTSD
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
VA Boston Healthcare System
Conditions:
FM and PTSD
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The most recent conflicts are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions, including Fibromyalgi...
Detailed Description
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight, this study is temporarily suspended as of 3/15/20. This study will compare the effects of a 12-week progr...
Eligibility Criteria
Inclusion
- Only Veteran and civilian participants in whom a physical examination and medical history indicate that the participant meets current diagnostic criteria for FM, as specified by the American College of Rheumatology, will be eligible for the study.
- Eligible participants who agree to a blood draw for measurement of biomarkers, must be free of medications and other substances (e.g., illicit drugs and alcohol) that may alter results for 2-6 weeks depending on the medication and frequency of use (which must be cleared by MD consultants).
- If on pain medications with short half-lives, participants must be off of them for 5 half-lives before testing, generally about 24 hours.
- Any FM participant with an ICD-10 chronic pain diagnosis of a musculoskeletal etiology, will also be eligible for inclusion in the study as many individuals with FM also have such conditions.
- Any participant with a confirmed psychiatric diagnosis of PTSD will be included in the study. Individuals in the PTSD group must meet diagnostic criteria for current chronic PTSD (\>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.
Exclusion
- Participants will be excluded from participation in the study if they have a life threatening or acute physical illness (e.g., cancer)
- Current schizophreniform illnesses (except for Psychosis NOS due to PTSD-related sensory hallucinations)
- Untreated bipolar disorder
- Or active suicidal or homicidal ideation requiring clinical intervention
- Individuals with current or past alcohol and/or substance dependence (less than three months from date of screening assessment) will be excluded
- Individuals seeking interventional pain treatment, such as surgical interventions or other pain clinic interventions, will also be excluded unless they agree to participate in the biomarker procedure prior to the start of their pain intervention.
- Finally, participants who have a neuropathic origin to their pain will be excluded.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03236467
Start Date
January 1 2018
End Date
August 31 2022
Last Update
November 3 2022
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130