Chronic Low Back Pain and Osteopathic Manipulation Treatment

Part of paid clinical trials in Hines, Illinois.

Sponsor
Edward Hines Jr. VA Hospital
Study ID
NCT07161661
Status
Recruiting
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Conditions

  • Chronic Low Back Pain (CLBP)
  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual VA Care — PROCEDURE
    The usual treatment provided by PM\&R clinicians for CLBP
  • Osteopathic manipulative treatment — PROCEDURE
    Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.

Study Details

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.

Key Dates

Start date
Mar 2, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual VA Care Group
    All study participants will receive usual VA care that will be provided by a physiatrist at the Hines VA. After taking their medical history, they will perform a physical exam to assess their conditions. Based on the physical exam, the physicians may recommend more testing and/or treatment procedures.
  • Experimental: Usual VA Care + OMT Group
    Participants in this group will receive your usual VA care plus OMT. The addition of OMT is the research portion of the treatment. During the physician prescribed usual care visits, participants will receive the OMT treatment. During OMT (the research portion), a physician may move participants muscles and joints using hands-on techniques including stretching, gentle pressure and resistance, as well as applying forces to specific areas of the body. While receiving OMT, participants may be asked to change positions such as standing, sitting, or lying on your back, stomach or side. This treatment will be provided by the VA physicians involved in this study.

Primary Outcome Measure

Low-Back Pain Specific Pain Intensity [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Edward Hines, Jr. VA Hospital, PM&R ClinicHinesIllinois60141-

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