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Completed

NCT Number: NCT05234840

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

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.

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Key information

Conditions

PRP

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuenrutai

Chon Buri, 20110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Drug
  • 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

Other names: PRP

Triamcinolone

Drug

40 mg triamcinolone with 1% lidocaine, total of 2 ml

Other names: kenacort

Primary outcomes

  1. VAS of leg pain

    Time frame: at 24 weeks

    0-100 (visual analog score, 0 is the minimum and 100 is the maximum)

Secondary outcomes

  1. VAS of back

    Time frame: at 24 weeks

    0-100 (visual analog score, 0 is the minimum and 100 is the maximum)

  2. ODI

    Time frame: at 24 weeks

    Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum)

  3. adverse event

    Time frame: up to 24 weeks

    minor and major complications from injection

  4. Rate of treatment failure [participant who require reinjection or operation]

    Time frame: up to 24 weeks

    During follow-up period, participant require either re-injection or operation [yes/no]

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2022
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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