Chronic Low Back Pain and Osteopathic Manipulation Treatment

NCT07161661 | Recruiting

• 2 other identifiers: 1850064-1Department of Defense
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Low-Back Pain Specific Pain Intensity

  A numeric pain rating scale (NPRS) question adapted by the BACPAC to obtain pain rating for over last 7 days.

  Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (16)

• Pain, Enjoyment, General Activity Scale (PEG)

  Baseline, 12 weeks, and 24 weeks

• Brief Pain Inventory (BPI)

  Baseline, 12 weeks, and 24 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  Baseline, 12 weeks, and 24 weeks

• Patient Health Questionnaire (PHQ-2)

  Baseline, 12 weeks, and 24 weeks

• Generalized Anxiety Disorder 2-item (GAD-2)

  Baseline, 12 weeks, and 24 weeks

Study Arms (2)

Usual VA Care Group

ACTIVE COMPARATOR

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.

Procedure: Usual VA Care

Usual VA Care + OMT Group

EXPERIMENTAL

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.

Procedure: Usual VA Care; Procedure: Osteopathic manipulative treatment

Interventions

Usual VA Care PROCEDURE

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

Usual VA Care + OMT Group; Usual VA Care Group

Osteopathic manipulative treatment PROCEDURE

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

Also known as: Osteopathic Neuromuscular Manipulative Medicine

Usual VA Care + OMT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Hines Jr. VA Hospital: lead
• Michigan State University: collaborator

Study Sites (1)

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

Hines, Illinois, 60141, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

CONTACT

708-202-2282; TBD@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VA WOC

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)