PRP Injections for Low Back Pain
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on opioid medication greater than or equal to 50 MME, you cannot participate in the trial.
What data supports the effectiveness of the treatment Platelet Rich Plasma (PRP) for low back pain?
Is PRP generally safe for humans?
How is PRP treatment different from other treatments for low back pain?
PRP (Platelet-Rich Plasma) treatment is unique because it uses a patient's own blood components, specifically platelets, which are rich in growth factors that may promote healing and reduce inflammation. Unlike standard treatments that often only relieve symptoms, PRP aims to regenerate and restore the function of damaged tissues in the spine.23457
What is the purpose of this trial?
Low back pain (LBP) is both the single most common cause of disability and the leading cause of visits when military personnel go to their primary care doctors. Military personnel that deal with LBP can often be placed on limited duty profile. Not surprisingly, the direct and indirect costs of low back and neck pain accounts for approximately $88 billion of health care expenditure. In order to reduce the large financial and personal cost, clinical studies must be designed to treat LBP. This study will provide evidence-based medicine on a new regenerative medicine treatment option that may significantly affect military personnel with LBP. PRP (Platelet Rich Plasma) may offer alternate treatment methods that may help preserve the facet joint structures, and improve pain and function without causing destructive lesions or worsening degenerative joints. This healing process may favor improved participation with rehabilitation therapy and ultimately improve return to duty status. This study will also assess the effectiveness of point of care generated PRP, as a minimally invasive treatment option for treating lumbar facet pain. Specifically, PRP effectiveness will be compared to injecting placebo control when injected into facet joints.
Research Team
Min Ho Chang, MD
Principal Investigator
Womack Army Medical Center
Eligibility Criteria
This trial is for military personnel aged 18-75 with chronic low back pain lasting over 3 months, who have not had recent spinal interventions or lumbar fusion, and are not on high opioid doses. Participants must speak English, be DEERS eligible, and able to consent. They should have a positive response to a diagnostic block injection but can't join if they're pregnant, moving soon, or have certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either PRP or placebo injection into the lumbar facet joint
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional PRP Extension for Control Group
Control group participants may opt to receive PRP injection at 3 months and continue follow-up
Treatment Details
Interventions
- Platelet Rich Plasma
Platelet Rich Plasma is already approved in United States, European Union for the following indications:
- Facet-mediated lumbar low back pain
- Degenerative joint disease
- Chronic pain
- Orthopedic conditions
- Musculoskeletal disorders
- Pain management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Womack Army Medical Center
Lead Sponsor
The Geneva Foundation
Collaborator
Uniformed Services University of the Health Sciences
Collaborator