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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique du Sport, Bordeaux Mérignac

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with infections,

Patients who have had previous percutaneous corticosteroid injections,

Patients undergoing systemic corticosteroid treatment,

Patients with immune deficiencies,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epidural Steroid Injection

    Procedure/Surgery

    Intervention consists of interlaminar CT guided epidural steroid injection

  • Epidural platelet-rich plasma injection

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: steroid treatmentActive comparator 1 intervention
Group B: platelet-rich plasma treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Functional ability

Oswestry Disability Questionnaire ranging from 0 to 100%

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

Secondary outcomes

1

Pain evaluation

Numerical pain rating scale (NRS): intensity of combined pain in the legs and back ranging from 0 to 10

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

Other outcomes

Sponsors and contacts

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