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

PRP Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234840
• Other study ID #: 015/2563
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2022
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• PRP

Intervention

Drug:
• platelet rich plasma
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
• Triamcinolone
40 mg triamcinolone with 1% lidocaine, total of 2 ml

Locations

Country	Name	City	State
Thailand	Chuenrutai	Chon Buri

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Becker C, Heidersdorf S, Drewlo S, de Rodriguez SZ, Krämer 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. Erratum in: Spine. 2007 Nov 15;32(24):table of contents. Dosage error in article text. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS of leg pain	0-100 (visual analog score, 0 is the minimum and 100 is the maximum)	at 24 weeks
Secondary	VAS of back	0-100 (visual analog score, 0 is the minimum and 100 is the maximum)	at 24 weeks
Secondary	ODI	Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum)	at 24 weeks
Secondary	adverse event	minor and major complications from injection	up to 24 weeks
Secondary	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