Intradiscal Platelet Rich Plasma

NCT04544709 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB 117455
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).

Conditions

Discogenic Pain; Low Back Pain; Chronic Pain

Keywords

Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale for Low Back Pain at 2-Month Follow-up

  Proportion of participants with ≥80% and ≥50% reductions from baseline in 7-day average low back pain intensity scores on the Numeric Rating Scale (NRS) at the 2-month follow-up assessment.

  2 months

Secondary Outcomes (11)

• Median Change in Low Back Pain Numeric Rating Scale (NRS) Score

  1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

• Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI)

  1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

• Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)

  1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

• Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points

  1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

• Oswestry Disability Index (ODI) Change Scores

  1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Study Arms (1)

Discogenic Low Back Pain

OTHER

Patient with Refractory Discogenic Low back pain who will be scheduled for platelet rich plasma injection as standard of care.

Drug: Low back intradiscal injection of platelet rich plasma (PRP)

Interventions

Low back intradiscal injection of platelet rich plasma (PRP) DRUG

SOC Intradiscal Lumbar PRP Procedure : A small amount of blood is drawn from you, then it is spun in a centrifuge to obtain only the platelets and few other cells. After being spun the small amount of platelets will be injected into the specific disc that is believed to be causing pain in an attempt to help reduce inflammation and pain at the site. The injection will be done under fluoroscopic guidance (x-ray) that allows very careful and precise placement of the needle.

Discogenic Low Back Pain

Eligibility Criteria

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

You may qualify if:

• Age greater than 18 years of age at day of enrollment.
• Clinical diagnosis of refractory discogenic low back pain for \>3 months.
• Magnetic resonance imaging pathology consistent with clinical symptoms/signs or positive lumbar provocative discography according to SIS/IASP standards at one or two levels.
• Back pain greater than leg pain with an intensity of at least 4/10 or higher using the Numerical Rating Scale (NRS).
• Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.

You may not qualify if:

• Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
• Contraindications to intradiscal injection of PRP (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
• More than 2 levels of clinical or discogram proven pain.
• Non-discogenic source of low back pain as identified by separate diagnostic blocks.
• Negative lumbar provocation discography.
• Active moderate to severe lumbar radiculopathy.
• Intradural disc herniation.
• Spinal fracture within the past 6 months.
• Steroid injection in the spine within the last 30 days.
• Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.
• Prior fusion at level considered to be the source of the pain.
• Prior lumbar spine surgery within the last 6 months.
• AP diameter of spinal canal less than or equal to 9mm at level to be treated.
• Severe uncontrolled medical condition.
• Moderate to severe hepatic dysfunction.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The single greatest limitation is that the study was ended early due to extremely low participant enrollment.

Results Point of Contact

• Title: Heather Littell, Regulatory Coordinator
• Organization: University of Utah Orthopaedics Center

u6041929@utah.edu

801-587-5432

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: February 14, 2019
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)