Exercise Maintenance in Chronic Pain and PTSD
Chronic Low Back Pain, Posttraumatic Stress Disorder
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Veterans, Cardiopulmonary exercise testing, Exercise maintenance, Neuropeptide Y (NPY), Exercise-related intrinsic motivation, Exercise Self efficacy, Transtheoretical Model (TTM), Self-Determination Theory (SDT)
Eligibility Criteria
Inclusion Criteria:
- ICD-9 or ICD-10 diagnosis of chronic low back pain, as confirmed by the rehabilitation medicine doctor consulting to the study, and a confirmed comorbid psychiatric diagnosis of PTSD. More specifically, the CLBP/PTSD participant must meet for current chronic PTSD (>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.
- A medical history, physical examination, vital signs, EKG, and baseline laboratory studies, including urine toxicology screens and a negative urine pregnancy test (woman only), indicate that symptom-limited cardiopulmonary exercise stress (CPX) testing will be safe.
- Women of child bearing capacity must agree to use effective contraception while participating; a urine pregnancy test performed on the morning prior to completing CPX testing will also be done.
- Relatively sedentary at enrollment, as defined by the American College of Sports Medicine (i.e., performing less than 30 minutes/day and less than 150 minutes per week of moderate physical activity).
- Free of medications and other substances (e.g., illicit drugs and alcohol) with effects that could hinder data interpretation for 2-6 weeks before the cold pressor test (CPT) and CPX testing depending on the medication and frequency of use (which must be cleared by the study Co-I and study MD, Dr. Rasmusson).
- Psychotropic medications are allowed, as long as the participant has been stable on them for two months.
- Tobacco product use is allowed; participants will not be required to lower or stop their dosage/intake; intensity of smoking will be monitored across the study via use of urine testing for cotinine (a long-lived metabolite of nicotine) at each test session. Regular morning nicotine users will be instructed to smoke/chew to satisfaction just prior to arriving at the Clinical Studies Unit for testing, which will be approximately 2-3 hours prior to performance of the CPT and CPX.
- Using pain medications other than opiates provided none taken for 5 half-lives before CPT/CPX testing, generally about 24 hours.
- Other anxiety or depressive disorders are permitted
- May be involved in supportive psychotherapies as long as their participation has been stable for 3 months prior to study entry and remains stable throughout the course of the study
- Can have a mild to moderate TBI, as determined by the BAT-L assessment.
- Taking medications for chronic psychiatric or medical illnesses is allowed as long as the medications and medication dosing are stable for two months prior to participation in the study and remain stable throughout the 12 week exercise training protocol and final exercise test.
Exclusion Criteria:
- A life threatening or acute physical illness (e.g., cancer), current schizophreniform illnesses, bipolar disorder, or active suicidal or homicidal ideation requiring clinical intervention.
- Current or past alcohol and/or substance dependence (less than three months from date of screening assessment)
- Current opiate pain medication use
- Women who are or are planning to become pregnant within the next six months
- Individuals seeking pain treatment such as surgical interventions or who have a neuropathic origin to their pain
- Cannot tolerate exercising on a treadmill or on an upright bike due to chronic pain
- 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) and more than first degree atrioventricular block
- Severe TBI, as evidenced on the VA TBI screen and the BAT-L assessment.
Sites / Locations
- VA Boston Healthcare System
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Progressive exercise program
Waitlist Control
Based on the "Active Physical Treatment Model" individuals with chronic pain are typically and primarily sedentary or physically deconditioned and need a progressive approach to work up to standard exercise prescriptions as defined by the American College of Sports Medicine. Thus, progressive exercise training can help to minimize the risk or occurrence of a range of exercise-related adverse medical events, particularly with the complex study population which will be starting at a sedentary level and therefore, may not be able to initially achieve the heart rate goals prescribed in standard exercise training protocols. The exercise prescription will be individually designed and geared toward an intensity manageable by the individual.
The waitlist control participants will be fully screened for eligibility and asked to wait 12 weeks before beginning the 12-week progressive exercise program. They will be assessed again at the end of the 12-week waiting period. These patients will then be compared to patients in the experimental arm and then compared against their own waitlist control data after completing the 12-week exercise program. The exercise program that the waitlist control patients will participate in is identical to the experimental arm.