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Recruiting NCT07036445

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

No phase Interventional Herniated Disc

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epidural Steroid Injection, Epidural platelet-rich plasma injection.
Who it may be relevant to
Registry conditions: Herniated Disc. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain : a Prospective Study With Long Term Follow up

Overview

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).

Interventions

  • Procedure Epidural Steroid Injection
    Intervention consists of interlaminar CT guided epidural steroid injection
  • Procedure Epidural platelet-rich plasma injection
    Intervention consists of interlaminar CT guided epidural platelet-rich plasma injection after recovery of plasma by blood sampling and centrifugation

Primary outcome measures

  • Functional ability [Time frame: 30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure]
Secondary outcome measures (1)
  • Pain evaluation [Time frame: 6 weeks, 6 months, 1 year and 2 years after procedure]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Clinique du Sport — Mérignac

Identifiers

NCT: NCT07036445 · 2024-38-SBM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗