Status:

COMPLETED

Platelet Rich Plasma (PRP) for Facet Mediated Lumbar Low Back Pain

Lead Sponsor:

Womack Army Medical Center

Collaborating Sponsors:

Uniformed Services University of the Health Sciences

The Geneva Foundation

Conditions:

Facet Joint Pain; Low Back Pain

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

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 c...

Detailed Description

This randomized controlled trial will determine the efficacy of platelet rich plasma vs. Control/Placebo. 170 healthy, physically active individuals with facet mediated lumbar low back pain will be re...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

September 29 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 23 2025

Estimated Enrollment :

91 Patients enrolled

Trial Details

Trial ID

NCT04822753

Start Date

September 29 2021

End Date

June 23 2025

Last Update

July 11 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Womack Army Medical Center

Fort Liberty, North Carolina, United States, 28310