Chronic Low Back Pain and Osteopathic Manipulation Treatment
NCT ID: NCT07161661
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-11-01
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Usual VA Care
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Michigan State University
OTHER
Edward Hines Jr. VA Hospital
FED
Responsible Party
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Clarence Nicodemus
VA WOC
Locations
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Edward Hines, Jr. VA Hospital, PM&R Clinic
Hines, Illinois, United States
Countries
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Central Contacts
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Role: CONTACT
Other Identifiers
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Department of Defense
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1850064-1
Identifier Type: -
Identifier Source: org_study_id
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