"Platelet-Rich Plasma" Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
Primary Purpose
PRP
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
platelet rich plasma
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for PRP focused on measuring PRP, HNP, lumbar HNP
Eligibility Criteria
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
Sites / Locations
- Chuenrutai
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Triamcinolone group
Platelet-rich plasma
Arm Description
Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy.
Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy.
Outcomes
Primary Outcome Measures
VAS of leg pain
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
Secondary Outcome Measures
VAS of back
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
ODI
Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum)
adverse event
minor and major complications from injection
Rate of treatment failure [participant who require reinjection or operation]
During follow-up period, participant require either re-injection or operation [yes/no]
Full Information
NCT ID
NCT05234840
First Posted
January 10, 2022
Last Updated
February 1, 2022
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT05234840
Brief Title
"Platelet-Rich Plasma" Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
Official Title
"Platelet-Rich Plasma" Transforaminal Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRP
Keywords
PRP, HNP, lumbar HNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
all patient were masked. Surgeon was blinded by leukostrip around injection syringe. Assessor was blinded from operative information.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triamcinolone group
Arm Type
Active Comparator
Arm Description
Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy.
Arm Title
Platelet-rich plasma
Arm Type
Experimental
Arm Description
Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy.
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
kenacort
Intervention Description
40 mg triamcinolone with 1% lidocaine, total of 2 ml
Primary Outcome Measure Information:
Title
VAS of leg pain
Description
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
Time Frame
at 24 weeks
Secondary Outcome Measure Information:
Title
VAS of back
Description
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
Time Frame
at 24 weeks
Title
ODI
Description
Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum)
Time Frame
at 24 weeks
Title
adverse event
Description
minor and major complications from injection
Time Frame
up to 24 weeks
Title
Rate of treatment failure [participant who require reinjection or operation]
Description
During follow-up period, participant require either re-injection or operation [yes/no]
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chuenrutai
City
Chon Buri
ZIP/Postal Code
20110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data was save in form of Microsoft excel spreadsheet and STATA file.
Citations:
PubMed Identifier
25722595
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.
Results Reference
background
PubMed Identifier
17762286
Citation
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. Erratum In: Spine. 2007 Nov 15;32(24):table of contents. Dosage error in article text.
Results Reference
background
PubMed Identifier
29177632
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
26713125
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.
Results Reference
background
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"Platelet-Rich Plasma" Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
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