Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain

NCT07036445 | Recruiting

• 1 other identifier: 2024-38-SBM
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of persistent lumbar radicular pain (LRP) using CT-guided epidural steroid injection (ESI) is widely used and associated with rare but serious complications. Platelet-rich plasma (PRP), which has recently been shown to promote healing and the anti-inflammatory process by delivering growth factors and cytokines, could be an alternative and potentially safer option. A previous study showed that PRP was as effective as ESI in treating this condition, without major complications. This study aims to compare these two treatments over the long term (2 years).

Conditions

Herniated Disc

Outcome Measures

Primary Outcomes (1)

• Functional ability

  Oswestry Disability Questionnaire ranging from 0 to 100%

  30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure

Secondary Outcomes (1)

• Pain evaluation

  6 weeks, 6 months, 1 year and 2 years after procedure

Study Arms (2)

steroid treatment

ACTIVE COMPARATOR

Procedure: Epidural Steroid Injection

platelet-rich plasma treatment

EXPERIMENTAL

Procedure: Epidural platelet-rich plasma injection

Interventions

Epidural Steroid Injection PROCEDURE

Intervention consists of interlaminar CT guided epidural steroid injection

steroid treatment

Epidural platelet-rich plasma injection PROCEDURE

Intervention consists of interlaminar CT guided epidural platelet-rich plasma injection after recovery of plasma by blood sampling and centrifugation

platelet-rich plasma treatment

Eligibility Criteria

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

You may qualify if:

• Diagnosis of unilateral resistant LRP associated with a herniated disc on MRI images. (Diagnosis of resistance after 6 weeks of appropriate medical treatment).

You may not qualify if:

• Patients with infections,
• Patients who have had previous percutaneous corticosteroid injections,
• Patients undergoing systemic corticosteroid treatment,
• Patients with immune deficiencies,
• Patients who are allergic to the contrast medium used,
• Pregnant or breastfeeding patients,
• Patients with a history of allergies to anesthetics or corticosteroids,
• Anticoagulant treatment or blood disorders, patients on antiplatelet therapy
• Taking NSAIDs within two weeks prior to the procedure

Sponsors & Collaborators

• Clinique du Sport, Bordeaux Mérignac: lead

Study Sites (1)

Clinique du Sport

Mérignac, 33700, France

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)