Chronic Low Back Pain and Osteopathic Manipulation Treatment

Edward Hines Jr. VA Hospital

Status: Enrolling

Conditions: Chronic Low Back Pain (CLBP); Low Back Pain

Treatments: Procedure: Usual VA Care; Procedure: Osteopathic manipulative treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07161661

Department of Defense (Other Grant/Funding Number)

1850064-1

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Usual VA Care Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Usual VA Care

Usual VA Care + OMT Group

Experimental group

Description:

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.

Treatment:

Procedure: Osteopathic manipulative treatment

Procedure: Usual VA Care