NCT03644927

Exercise Maintenance in Chronic Pain and PTSD

Terminated NA Results posted Last updated 25 January 2023

What this trial tests

NA trial testing Progressive exercise training in Chronic Low Back Pain in 11 participants. Terminated before completion.

Timeline

22 January 2019

Primary endpoint
6 January 2022

6 January 2022

Quick facts

Lead sponsor	Boston University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	22 January 2019
Primary completion	6 January 2022
Estimated completion	6 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Progressive exercise training
• Waitlist Control

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →
• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

Boston University

Who can join

Adults 18 to 65, any sex, with Chronic Low Back Pain or Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for the 6 weeks that one participant received the study intervention prior to study termination. In addition prior to randomization two participants had an adverse event during the rigorous and conservative screening process and they were not allowed to proceed to the intervention. One participant felt nauseous and had a headache and the other had abnormal EKG findings and a positive history for cardiac issues.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Progressive Exercise Program

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (3 terms — click to expand)

Reaction	System	Progressive Exercise Program
Nausea	Gastrointestinal disorders	—
Headache	General disorders	—
Cardiac abnormalities	Cardiac disorders	—

Data from ClinicalTrials.gov NCT03644927 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Moderated mediation for exercise maintenance in pain and posttraumatic stress disorder: A randomized trial.
   Scioli ER, Smith BN, Whitworth JW, Spiro A, et al · · 2020 · cited 3× · PMID 32833484 · DOI 10.1037/hea0000876