Recruiting

OMT with Usual Care

Sponsor:

Edward Hines Jr. VA Hospital

Code:

NCT07161661

Conditions

Chronic Low Back Pain (CLBP)

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual VA Care

Osteopathic manipulative treatment

Study Details

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.

Conditions

Chronic Low Back Pain (CLBP)

Low Back Pain

Study ID

NCT07161661

Start date

Mar 2, 2026

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Usual VA Care

The usual treatment provided by PM\&R clinicians for CLBP

Osteopathic manipulative treatment

Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

708-202-2282TBD@va.gov

Locations

Edward Hines, Jr. VA Hospital, PM&R Clinic

Recruiting

Hines, Illinois, United States, 60141

More Information

Sponsor

Edward Hines Jr. VA Hospital

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Osteopathic manipulative treatment
  • Physical Medicine and Rehabilitation
  • Veterans
  • Osteopathic manipulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Edward Hines Jr. VA Hospital on 2026-05-22.