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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: Usual VA Care
    The usual treatment provided by PM&R clinicians for CLBP
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.
  • Procedure: Usual VA Care
    The usual treatment provided by PM&R clinicians for CLBP
  • Procedure: Osteopathic manipulative treatment
    Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.
    Other names:
    • Osteopathic Neuromuscular Manipulative Medicine

Recruiting Locations

Edward Hines, Jr. VA Hospital, PM&R Clinic
Hines, Illinois 60141

More Details

Status
Recruiting
Sponsor
Edward Hines Jr. VA Hospital

Study Contact

708-202-2282
TBD@va.gov

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.