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

NCT05234840 | Completed DMC

• 1 other identifier: 015/2563
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PRP

Keywords

PRP, HNP, lumbar HNP

Outcome Measures

Primary Outcomes (1)

• VAS of leg pain

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

  at 24 weeks

Secondary Outcomes (4)

• VAS of back

  at 24 weeks

• ODI

  at 24 weeks

• adverse event

  up to 24 weeks

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

  up to 24 weeks

Study Arms (2)

Triamcinolone group

ACTIVE COMPARATOR

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

Drug: Triamcinolone

Platelet-rich plasma

EXPERIMENTAL

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

Drug: platelet rich plasma

Interventions

platelet rich plasma DRUG

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

Also known as: PRP

Platelet-rich plasma

Triamcinolone DRUG

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

Also known as: kenacort

Triamcinolone group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous spine surgery or epidural injection
• Progressive neurological deficit
• Cauda equina
• Coagulopathy-related conditions
• Associated cervical myelopathy
• Systemic bone and joint diseases

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Chuenrutai

Chon Buri, 20110, Thailand

Location

Related Publications (6)

• Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.

  PMID: 25722595 BACKGROUND

• Becker C, Heidersdorf S, Drewlo S, de Rodriguez SZ, Kramer J, Willburger RE. Efficacy of epidural perineural injections with autologous conditioned serum for lumbar radicular compression: an investigator-initiated, prospective, double-blind, reference-controlled study. Spine (Phila Pa 1976). 2007 Aug 1;32(17):1803-8. doi: 10.1097/BRS.0b013e3181076514.

  PMID: 17762286 BACKGROUND

• Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.

  PMID: 29177632 BACKGROUND

• Cameron JA TK. Autologous Platelet Rich Plasma for Neck and Lower Back Pain Secondary to Spinal Disc Herniation: Midterm Results. Spine Res 2017;32.

  BACKGROUND

• H S RK, Goni VG, Y K B. Autologous Conditioned Serum as a Novel Alternative Option in the Treatment of Unilateral Lumbar Radiculopathy: A Prospective Study. Asian Spine J. 2015 Dec;9(6):916-22. doi: 10.4184/asj.2015.9.6.916. Epub 2015 Dec 8.

  PMID: 26713125 BACKGROUND

• Wongjarupong A, Pairuchvej S, Laohapornsvan P, Kotheeranurak V, Jitpakdee K, Yeekian C, Chanplakorn P. "Platelet-Rich Plasma" epidural injection an emerging strategy in lumbar disc herniation: a Randomized Controlled Trial. BMC Musculoskelet Disord. 2023 Apr 28;24(1):335. doi: 10.1186/s12891-023-06429-3.

  PMID: 37118707 DERIVED

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: all patient were masked. Surgeon was blinded by leukostrip around injection syringe. Assessor was blinded from operative information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 10, 2022
• Study Start: April 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: June 30, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

TH (1)