Chronic Low Back Pain and Osteopathic Manipulation Treatment

NCT ID: NCT07161661

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain (CLBP) Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Usual VA Care

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Usual VA Care

Intervention Type PROCEDURE

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

Osteopathic manipulative treatment

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Usual VA Care

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

Intervention Type PROCEDURE

Osteopathic manipulative treatment

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Osteopathic Neuromuscular Manipulative Medicine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michigan State University

OTHER

Sponsor Role collaborator

Edward Hines Jr. VA Hospital

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clarence Nicodemus

VA WOC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Hines, Illinois, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Role: CONTACT

708-202-2282

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Department of Defense

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1850064-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.