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

NCT04822753 | Completed

• 1 other identifier: WAMC.2021.0053
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Facet Joint Pain; Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  Assesses average daily pain on a scale from 0-10

  3 months

Secondary Outcomes (6)

• Numeric Rating Scale (NRS)

  6 months

• Defense Veteran Pain Rating Scale+ Supplemental Questions (DVPRS)

  3 and 6 months

• Oswestry Disability Index (ODI)

  3 and 6 months

• Global Rate of Change (GROC)

  3 and 6 months

• Patient Reported Outcomes Measurement Information System 29 and derived Pain Impact Scale(PROMIS-29)

  3 and 6 months

Study Arms (2)

Platelet Rich Plasma injection to lumbar facet joint

EXPERIMENTAL

Platelet Rich Plasma injection to lumbar facet joint

Procedure: Platelet Rich Plasma injection to the lumbar facet joint

Placebo injection to lumbar facet joint

PLACEBO COMPARATOR

Placebo injection to lumbar facet joint

Procedure: Platelet Rich Plasma injection to the lumbar facet joint

Interventions

Platelet Rich Plasma injection to the lumbar facet joint PROCEDURE

Using standard fluoroscopic view, place a needle at the target facet joint. Inject about 1ml of study injectate.

Placebo injection to lumbar facet joint; Platelet Rich Plasma injection to lumbar facet joint

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Womack Army Medical Center: lead
• Uniformed Services University of the Health Sciences: collaborator
• The Geneva Foundation: collaborator

Study Sites (1)

Womack Army Medical Center

Fort Liberty, North Carolina, 28310, United States

Location

Related Publications (15)

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  PMID: 26906169 RESULT

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  PMID: 27906940 RESULT

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  PMID: 28509821 RESULT

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Min Ho Chang, MD

  Womack Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single blinded, assessor blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: September 29, 2021
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)