Chronic Low Back Pain and Osteopathic Manipulation Treatment (NCT07161661) | Clinical Trial Compass
RecruitingNot Applicable
Chronic Low Back Pain and Osteopathic Manipulation Treatment
United States48 participantsStarted 2026-03-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses osteopathic manipulation treatment for chronic low back pain — how does that approach compare to what I'm already doing or what standard care would look like for my situation?
2Since this trial is listed as Phase NA, meaning it's not a traditional drug trial, what is actually known about the safety of osteopathic manipulation for someone with my specific type of low back pain?
3The trial is measuring low-back pain specific pain intensity as its main outcome — can you help me understand what that means in practice, and whether a change in that measurement would translate to a real difference in my daily life?
4Given that this study is actively recruiting right now, what would my time commitment look like in terms of visits or treatments, and is that realistic given my current schedule and condition?
5Before considering this trial, should I try any other established treatments for chronic low back pain first, or is there a reason this study might be a good fit to explore at this point in my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.