Exploring non-medication options for managing chronic pain in Veterans
Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)
This study is testing different non-medication methods, like therapy and exercise, to help Veterans manage their chronic pain without relying on drugs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05563792 on ClinicalTrials.gov |
What this trial studies
This study aims to assist Veterans in managing chronic pain through non-pharmacological strategies rather than medications. Participants will work with a coach to identify their personal values and goals, and explore various non-medication approaches that align with these. The study emphasizes the use of evidence-based treatments such as cognitive behavioral therapy, exercise, acupuncture, and yoga, which are widely available within the Veterans Health Administration. The initiative is part of a broader effort to reduce reliance on opioids and promote multimodal pain management strategies.
Who should consider this trial
Good fit: Ideal candidates are Veterans experiencing musculoskeletal pain in the low back, cervical spine, or extremities for at least three months, with moderate pain intensity and a willingness to try new treatments.
Not a fit: Patients with severe medical conditions, long-term opioid therapy, or significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide Veterans with effective pain management alternatives that improve their quality of life without the risks associated with opioid use.
How similar studies have performed: Other studies have shown success with similar non-pharmacological approaches to pain management, indicating a promising direction for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for at least 3 months, * have at least moderate pain intensity and interference with function, defined by a score of 4 (possible range: 0-10) on the PEG, a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity (obtained from phone screener), * have a primary care appointment scheduled or due in approximately the next three months. * open to trying new pain treatments Exclusion Criteria: * a psychiatric hospitalization in the past 6 months, * long-term opioid therapy * severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure) which includes heart attack, stroke, and cancer, or * if the eligibility screener reveals cognitive impairment, defined by a score of \>3 (possible range: 0-6) on MMSE cognitive screen (obtained from phone screener), or * if the eligibility screener reveals active suicidal ideation, or * severe hearing/speech impairment.
Where this trial is running
Indianapolis, Indiana
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Matthew J. Bair, MD MS — Richard L. Roudebush VA Medical Center, Indianapolis, IN
- Study coordinator: Marianne S Matthias, PhD MS BA
- Email: msmatthias@arizona.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.