NCT07161661 Chronic Low Back Pain and Osteopathic Manipulation Treatment
| NCT ID | NCT07161661 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edward Hines Jr. VA Hospital |
| Condition | Chronic Low Back Pain (CLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2026-03-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if adding Osteopathic Manipulative Therapy (OMT) to the usual medical care provided at the VA (usual VA care) improves treatment outcomes in individuals with chronic low back pain (CLBP). OMT is a set of hands-on techniques a doctor uses to move a patient's muscles and joints which include stretching, gentle pressure, resistance and applying forces to specific areas of the body. This feasibility clinical trial aims to learn about the treatment effects (e.g., effect sizes) of adding OMT to the usual medical care provided at the VA (Usual VA Care) in individuals with LBP.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07161661 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low Back Pain (CLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07161661 currently recruiting?
Yes, NCT07161661 is actively recruiting participants. Contact the research team at TBD@va.gov for enrollment information.
Where is the NCT07161661 trial being conducted?
This trial is being conducted at Hines, United States.
Who is sponsoring the NCT07161661 clinical trial?
NCT07161661 is sponsored by Edward Hines Jr. VA Hospital. The trial plans to enroll 48 participants.