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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Functional ability
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
steroid treatment
Intervention: Epidural Steroid Injection (Procedure)
platelet-rich plasma treatment
Intervention: Epidural platelet-rich plasma injection (Procedure)
Outcomes
Primary Outcomes
Functional ability
Time Frame: 30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure
Oswestry Disability Questionnaire ranging from 0 to 100%
Secondary Outcomes
- Pain evaluation(6 weeks, 6 months, 1 year and 2 years after procedure)