CompletedNot Applicable

Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD

United States23 participantsStarted 2014-08-25

Plain-language 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 deployment-related physical injuries and exposure to psychological trauma. Health behavior change has become increasingly important in treating these conditions and proactively preventing long-term negative health sequelae, in order to benefit these Veterans directly and reduce the growing challenges to the healthcare system. The proposed CDA-2 program of research will use an innovative translational research approach to study whether a chronic progressive -based exercise program will reduce chronic pain symptoms in patients with varying degrees of PTSD symptom severity and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise to optimize the physical and psychological benefits of exercise for these individuals.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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. *…

What they're measuring

Change From Baseline: PTSD Checklist-5 (PCL-5)

Timeframe: Baseline and endpoint (at 13 weeks)

Change From Baseline: West Haven-Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)

Timeframe: Baseline and endpoint (at 13 weeks)

Change From Baseline: Pain Catastrophizing Scale

Timeframe: endpoint (at 13 weeks)

Trial details

NCT IDNCT03283163

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2020-04-01

Results submitted2023-02-24

View on ClinicalTrials.gov More Chronic Musculoskeletal Pain trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline: PTSD Checklist-5 (PCL-5)

Timeframe: Baseline and endpoint (at 13 weeks)

Change From Baseline: West Haven-Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)

Timeframe: Baseline and endpoint (at 13 weeks)

Change From Baseline: Pain Catastrophizing Scale

Timeframe: endpoint (at 13 weeks)