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Recruiting NCT07161661

Chronic Low Back Pain and Osteopathic Manipulation Treatment

Trial Parameters

Condition Chronic Low Back Pain (CLBP)
Sponsor Edward Hines Jr. VA Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 48
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-01
Completion 2027-08-31
Interventions
Usual VA CareOsteopathic manipulative treatment

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

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