Exercise Maintenance in Chronic Pain and PTSD

Stopped early · Not applicable

Conditions studied: Chronic Low Back Pain, Posttraumatic Stress Disorder

In brief

The primary purpose of the R21 is using an experimental medicine research approach to study whether a chronic, progressive-based exercise program will help Veterans suffering from chronic low back pain (cLBP) and PTSD achieve exercise maintenance, and shared symptom reduction, through neuropeptide Y mediated improvements in putative factors (self-regulation and reward sensitivity) known to improve exercise related self-efficacy and motivation.

Key facts

Study ID

NCT03644927

Run by

Boston University

People needed

11

Starts

2019-01-22

Expected to finish

2022-01-06

Last updated by the study team

2023-01-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Boston Healthcare System — Jamaica Plain, Massachusetts, United States

Full record on ClinicalTrials.gov

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