Status:
COMPLETED
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Musculoskeletal Pain
Posttraumatic Stress Disorder (PTSD)
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The wars in Iraq and Afghanistan are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions from recent dep...
Detailed Description
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight, all study procedures are temporarily suspended as of 3/15/20. This study will explicitly examine the effe...
Eligibility Criteria
Inclusion
- Only Veteran and civilian participants in whom a physical examination, medical history, EKG, and baseline laboratory studies including urine toxicology screens indicate that maximum load exercise testing will be safe will be included in this study.
- Participants must be free of medications and other substances, (e.g., illicit drugs and alcohol) with effects that could hinder data interpretation for 2-6 weeks depending on the medication and frequency of use (which must be cleared by the PI's primary mentor).
- If on pain medications with short half-lives, must be off of them for 5 half-lives before testing, generally about 24 hours.
- Any participant with an ICD9 chronic pain diagnosis, with a musculoskeletal etiology, as confirmed by the study rehab medicine doctor, will be allowed for inclusion in the study.
- Also, any participant with a confirmed psychiatric diagnosis of PTSD
- or have trauma exposure without a diagnosis of PTSD but some symptoms of PTSD, including subthreshold PTSD
- other psychiatric conditions
- Individuals must meet for current chronic PTSD (\>3 months ) as assessed by the CAPS 1-Month Diagnostic Version.
Exclusion
- Veteran and civilian 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 or bipolar disorder
- or active suicidal or homicidal ideation requiring clinical intervention.
- Women participants who are pregnant or are intending to become pregnant within the next six months will be excluded from participation.
- Individuals with current or past alcohol and/or substance dependence (less than three months from date of screening assessment) will be excluded.
- individuals without PTSD who have had greater than one major depressive episode or diagnosis of another serious psychiatric illness in their past, e.g.:
- bipolar disorder or a schizophreniform disorder except for Psychosis not otherwise specified due to PTSD-related sensory hallucinations.
- Individuals seeking pain treatment such as surgical interventions or who have a neuropathic origin to their pain will also be excluded.
- Participants with chronic pain concerns that cannot tolerate exercising in a reclining bike and those who have had a clinical history of coronary artery disease or positive stress test
- Uncontrolled cardiac arrhythmia
- Moderate-to-severe aortic stenosis
- Severe arterial hypertension (systolic \>200 mmHg, diastolic\>110 mm Hg)
- More than first degree atrioventricular block also will be excluded from participation.
- Finally, participants who screen positive by answering all four items on the TBI assessment, will be excluded from participation.
Key Trial Info
Start Date :
August 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03283163
Start Date
August 25 2014
End Date
August 31 2022
Last Update
August 14 2024
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130