Platelet-Rich Plasma Epidural Injection an Emerging Strategy in Lumbar Disc Herniation

Study Overview
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Brief Summary
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To evaluate the efficacy of platelet-rich plasma (PRP; double-spin) in treatment of single-level lumbar herniated nucleus pulposus (HNP) in comparison to triamcinolone. RCT was conducted with 30 patients included.

Detailed Description
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The study was a randomized controlled trial, triple-blind, single-center/surgeon/assessor. The study was conducted between April 2019 to May 2021. We evaluated 30 patients (both genders) aged 20-55 years, having failed conservative treatment of unilateral HNP undergone for at least 6 weeks, with visual analogue scale (VAS) of greater than 30, and confirmed a single-level HNP, corelated to clinical, by MRI. The exclusion criteria included previous spine surgery or epidural injection, progressive neurological deficit, cauda equina, coagulopathy-related conditions, associated cervical myelopathy, systemic bone and joint diseases. All patients had to have been exempted from NSAIDs for at least one week. Patients were treated by transforaminal epidural injections. Fifteen patients were in triamcinolone and PRP groups each. PRP was obtained from 24 ml venous blood through standardized double-spin protocol. Participants were fifteen patients each in triamcinolone and PRP groups. The same postoperative protocols and medications were applied. The visual analogue scale of leg (LegVAS), collected at baseline, 2, 6, 12, and 24 weeks, was the primary outcome. The BackVAS, Oswestry Disability Index (ODI), adverse event, and treatment failure were the secondary endpoints. All subjects were analyzed according to the intention-to-treat principle. All statistical analyses were performed with STATA 17.

Official Title
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Platelet-Rich Plasma Transforaminal Epidural Injection an Emerging Strategy in Lumbar Disc Herniation

Conditions
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PRP

Intervention / Treatment
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* Drug: platelet rich plasma
* Drug: Triamcinolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-55 years Having failed conservative treatment for at least 6 weeks Visual analogue scale (VAS) of greater than 30 Confirmed a single-level HNP, corelated to clinical, by MRI. Exclusion Criteria: Previous spine surgery or epidural injection Progressive neurological deficit Cauda equina Coagulopathy-related conditions Associated cervical myelopathy Systemic bone and joint diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Thirty patients were treated by transforaminal epidural injections. Fifteen patients were in triamcinolone and PRP groups each. PRP was obtained from 24 ml venous blood through standardized double-spin protocol. Participants were fifteen patients each in triamcinolone and PRP groups. The same postoperative protocols and medications were applied. The visual analogue scale of leg (LegVAS), collected at baseline, 2, 6, 12, and 24 weeks, was the primary outcome.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triamcinolone group<br>Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy. | Drug: Triamcinolone<br>* 40 mg triamcinolone with 1% lidocaine, total of 2 ml<br>* Other names: kenacort;|
| Experimental: Platelet-rich plasma<br>Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy. | Drug: platelet rich plasma<br>* 1. 26 ml of blood was obtained from each patient (6ml each in 4 CPDA and 2ml in EDTA for CBC) 2. First-spin of 900g for 5 minutes (Kokusan, H-19alpha, 25°C) 3. Three layers formed: transfer top layer (platelet poor plasma) and middle layer (platelets and WBC) to another sterile tube (about 3.3 ml), discard bottom layer (RBC) 4. Second-spin of 1000g for 10 minutes 5. The upper one third was discarded (platelet poor plasma) by pipet, the remaining was mixed by turning 10 times 6. Total 4 ml of PRP<br>* Other names: PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS of leg pain | 0-100 (visual analog score, 0 is the minimum and 100 is the maximum) | at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS of back | 0-100 (visual analog score, 0 is the minimum and 100 is the maximum) | at 24 weeks | 
| ODI | Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum) | at 24 weeks | 
| adverse event | minor and major complications from injection | up to 24 weeks | 
| Rate of treatment failure [participant who require reinjection or operation] | During follow-up period, participant require either re-injection or operation [yes/no] | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, HNP, lumbar HNP