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

Not Applicable

Completed

• Conditions: PRP
• Interventions: Drug: platelet rich plasma; Drug: Triamcinolone

• Registration Number: NCT05234840
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-30
• Study First Submitted: 2022-01-10
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-rich plasma	platelet rich plasma	Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy.
Triamcinolone group	Triamcinolone	Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy.

Primary Outcome Measures

Name	Time	Method
VAS of leg pain	at 24 weeks	0-100 (visual analog score, 0 is the minimum and 100 is the maximum)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chuenrutai; 🇹🇭 Chon Buri, Thailand