Using Platelet Rich Plasma to Treat Low Back Pain in Military Personnel
A Randomized Placebo-Controlled Trial of Platelet Rich Plasma (PRP) for Facet Mediated Lumbar Low Back Pain
This study is testing if platelet rich plasma injections can help military personnel with chronic low back pain feel better and improve their daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Womack Army Medical Center Federal |
| Locations | 1 site (Fort Liberty, North Carolina) |
| Trial ID | NCT04822753 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of platelet rich plasma (PRP) injections for treating facet-mediated lumbar low back pain in military personnel. The study will recruit 170 healthy, physically active individuals who have chronic low back pain and will use a fluoroscopic guided diagnostic medial branch block (MBB) to confirm eligibility. Participants who show a significant reduction in pain after the MBB will receive the PRP injection, while those who do not will be withdrawn from the study. The aim is to provide a new treatment option that may improve pain and function without causing further joint damage.
Who should consider this trial
Good fit: Ideal candidates are active military personnel aged 18-75 with chronic low back pain lasting more than three months.
Not a fit: Patients with prior spinal interventions or certain spinal pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce low back pain and improve the quality of life for military personnel.
How similar studies have performed: Other studies have shown promise with PRP injections for various musculoskeletal conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult age 18-75 (inclusive) * DEERS eligible * Able to understand, read and speak English * Willing and able to provide written informed consent * Predominant area of pain is axial low back pain * Chronic low back pain lasting more than 3 months * Average daily numerical pain rating of at least 4 out of 10 * Single positive diagnostic medial branch block (MBB) of greater than or equal to 50% reduction in symptoms after local anesthetic injection Exclusion Criteria: * Prior spinal intervention such as epidural steroid injection or sacroiliac joint injection for current symptoms * Prior radiofrequency denervation for facet mediated pain * History of lumbar fusion * Allergic to local anesthetic such as lidocaine and ropivacaine * On opioid medication greater than or equal to 50 MME * Recent (within past 3 months) systematic or localized infection * Spinal pathology such as symptomatic radiculopathy or spinal stenosis within the past 3 months * Medical or psychological condition that would preclude safe participation in study procedures (e.g. uncontrolled coagulopathy, diabetes, uncontrolled immunosuppression, inflammatory arthritis, active malignancy, uncontrolled depression or anxiety, etc.) * Service member currently going through medical evaluation board * Scheduled to move, deploy, separate or retire within 6 months * Unable or unwilling to comply with study requirements * Currently pregnant or had a recent delivery (within past 3 months)
Where this trial is running
Fort Liberty, North Carolina
- Womack Army Medical Center — Fort Liberty, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Min Ho Chang, MD — Womack Army Medical Center
- Study coordinator: Carolyn Smith
- Email: csmith@genevausa.org
- Phone: 910-643-2310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.