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

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Completed

Conditions: PRP

Treatments: Drug: Triamcinolone; Drug: platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05234840

015/2563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Triamcinolone group

Active Comparator group

Description:

Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy.

Treatment:

Drug: Triamcinolone

Platelet-rich plasma

Experimental group

Description:

Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy.

Treatment:

Drug: platelet rich plasma