COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Placebo-Controlled Trial of Platelet Rich Plasma (PRP) for Facet Mediated Lumbar Low Back Pain

Quick Facts

Study Start:2021-09-29
Study Completion:2025-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04822753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult age 18-75 (inclusive)
  2. * DEERS eligible
  3. * Able to understand, read and speak English
  4. * Willing and able to provide written informed consent
  5. * Predominant area of pain is axial low back pain
  6. * Chronic low back pain lasting more than 3 months
  7. * Average daily numerical pain rating of at least 4 out of 10
  8. * Single positive diagnostic medial branch block (MBB) of greater than or equal to 50% reduction in symptoms after local anesthetic injection
  1. * Prior spinal intervention such as epidural steroid injection or sacroiliac joint injection for current symptoms
  2. * Prior radiofrequency denervation for facet mediated pain
  3. * History of lumbar fusion
  4. * Allergic to local anesthetic such as lidocaine and ropivacaine
  5. * On opioid medication greater than or equal to 50 MME
  6. * Recent (within past 3 months) systematic or localized infection
  7. * Spinal pathology such as symptomatic radiculopathy or spinal stenosis within the past 3 months
  8. * 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.)
  9. * Service member currently going through medical evaluation board
  10. * Scheduled to move, deploy, separate or retire within 6 months
  11. * Unable or unwilling to comply with study requirements
  12. * Currently pregnant or had a recent delivery (within past 3 months)

Contacts and Locations

Principal Investigator

Min Ho Chang, MD
PRINCIPAL_INVESTIGATOR
Womack Army Medical Center

Study Locations (Sites)

Womack Army Medical Center
Fort Liberty, North Carolina, 28310
United States

Collaborators and Investigators

Sponsor: Womack Army Medical Center

  • Min Ho Chang, MD, PRINCIPAL_INVESTIGATOR, Womack Army Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-29
Study Completion Date2025-06-23

Study Record Updates

Study Start Date2021-09-29
Study Completion Date2025-06-23

Terms related to this study

Keywords Provided by Researchers

  • platelet rich plasma (PRP)
  • Facet Joint
  • Low Back Pain

Additional Relevant MeSH Terms

  • Facet Joint Pain; Low Back Pain