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

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand (Other)
• Overall Status: Completed
• CT.gov ID: NCT05234840
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PRP	Drug: platelet rich plasma; Drug: Triamcinolone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: all patient were masked. Surgeon was blinded by leukostrip around injection syringe. Assessor was blinded from operative information.
• Primary Purpose: Treatment
• Official Title: "Platelet-Rich Plasma" Transforaminal Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Triamcinolone group Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy.	Drug: Triamcinolone; 40 mg triamcinolone with 1% lidocaine, total of 2 ml; Other Names: kenacort
Experimental: Platelet-rich plasma Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy.	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; Other Names: PRP

Outcome Measures

Primary Outcome Measures

1. VAS of leg pain [at 24 weeks]

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

Secondary Outcome Measures

1. VAS of back [at 24 weeks]

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

2. ODI [at 24 weeks]

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

3. adverse event [up to 24 weeks]

   minor and major complications from injection

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chuenrutai	Chon Buri		Thailand	20110

Sponsors and Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Queen Savang Vadhana Memorial Hospital, Thailand
• ClinicalTrials.gov Identifier: NCT05234840
• Other Study ID Numbers: 015/2563
• First Posted: Feb 10, 2022
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Queen Savang Vadhana Memorial Hospital, Thailand: PRP, HNP, lumbar HNP
• Additional relevant MeSH terms: Intervertebral Disc Displacement; Triamcinolone

Study Results

No Results Posted as of Feb 10, 2022