N/A
N=23
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
Chronic Musculoskeletal Pain · Posttraumatic Stress Disorder (PTSD) · Mild or Moderate Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03283163 ↗Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline: PTSD Checklist-5 (PCL-5) — 15.64 units on a scale — p=.040
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Testing and Training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline: PTSD Checklist-5 (PCL-5) |
15.64 | .040 sig |
| PRIMARY Change From Baseline: West Haven-Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI) |
2.56 | .69 |
| PRIMARY Change From Baseline: Pain Catastrophizing Scale |
13.92 | .098 |
| SECONDARY ALLO+PA Resting (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing |
5855.33 | .194 |
| SECONDARY ALLO+PA Peak (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing |
4062.50 | .343 |
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.
Eligibility Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03283163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.