Adding osteopathic manipulation to VA care for chronic low back pain
Feasibility of Implementing Manual Medicine in the Multimodal Management of Veterans and Service Members With Chronic Low Back Pain
This trial will test whether adding osteopathic manipulative therapy—hands-on techniques that move muscles and joints—to usual VA care helps veterans with chronic low back pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Edward Hines Jr. VA Hospital Federal |
| Locations | 1 site (Hines, Illinois) |
| Trial ID | NCT07161661 on ClinicalTrials.gov |
What this trial studies
This is a randomized feasibility trial comparing usual VA care alone versus usual VA care plus osteopathic manipulative treatment (OMT) in veterans with chronic low back pain. Eligible participants are adults receiving care at the participating VA clinic with low back pain lasting more than three months and recent pain of at least 3/10. OMT involves hands-on stretching, gentle pressure, resistance, and targeted forces applied by a trained clinician and will be provided in addition to standard VA management. The trial aims to estimate treatment effect sizes and feasibility outcomes such as recruitment, adherence, and safety to inform a larger definitive trial.
Who should consider this trial
Good fit: Veterans aged 18 or older who are seeking care at the participating VA clinic, have low back pain present for over three months (on at least half the days in the past six months), report recent pain of ≥3/10, can follow the protocol, and are willing to be randomized are ideal candidates.
Not a fit: Patients with signs of serious spinal pathology, systemic inflammatory or neurological disease, pregnancy, recent spinal surgery or fracture within the past year, active workers' compensation or litigation for back pain, recent manual therapies within three months, or other contraindications to OMT are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, adding OMT could reduce pain and improve function for veterans with chronic low back pain and possibly reduce reliance on pain medications.
How similar studies have performed: Previous randomized trials of OMT and other manual therapies have shown modest short-term improvements in pain and function for chronic low back pain, but adding OMT specifically within VA usual-care pathways has been less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age and older * Seeking care for LBP from a participating VA clinic * Able to follow study protocol * Willing to be randomized to Usual VA Care or Usual VA Care + OMT * Individuals with pain primarily in the LBP region lasting \> 3 months and present on at least half the days during the past 6 months * Pain rating over the past 7 days equal to or greater than 3/10 as indicated on the Numeric Rating Scale for Pain Exclusion Criteria: * Signs of serious pathology as a cause of LBP * Underlying systemic or inflammatory conditions * Neurological diseases * Pregnancy * Previous back surgery or spinal fracture within the past year * Active workers' compensation or litigation for back pain * Any conditions impeding study protocol implementation or contraindication to OMT * No PM\&R, OMT, chiropractic, or physical treatment where manual techniques are utilized within last 3mo
Where this trial is running
Hines, Illinois
- Edward Hines, Jr. VA Hospital, PM&R Clinic — Hines, Illinois, United States (Recruiting)
Study contacts
- Email: TBD@va.gov
- Phone: 708-202-2282
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.