PRPNCT05234840
"Platelet-Rich Plasma" Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
A study testing platelet rich plasma and Triamcinolone in people with PRP, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- PRP
- What is being tested?
- platelet rich plasma and Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous spine surgery or epidural injection
- Progressive neurological deficit
- Cauda equina
- Coagulopathy-related conditions
- Associated cervical myelopathy
- Systemic bone and joint diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Platelet-Rich Plasma" Transforaminal 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.
Read the 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.
- Conditions
- PRP
- Being tested
- platelet rich plasma, Triamcinolone
- Keywords
- PRP, HNP, lumbar HNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaDrug
Also called PRP
- 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
TriamcinoloneDrug
Also called kenacort
40 mg triamcinolone with 1% lidocaine, total of 2 ml
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone group | Active comparator | Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy. Receives: Drug: Triamcinolone |
| Platelet-rich plasma | Experimental | Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy. Receives: Drug: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS of leg pain
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
Measured: at 24 weeks
Secondary outcomes (4)
VAS of back
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
Measured: at 24 weeks
ODI
Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum)
Measured: at 24 weeks
adverse event
minor and major complications from injection
Measured: up to 24 weeks
Rate of treatment failure [participant who require reinjection or operation]
During follow-up period, participant require either re-injection or operation [yes/no]
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Apr 2019
- Primary completion1 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PRPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234840
- Sponsor's protocol ID
- 015/2563
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data was save in form of Microsoft excel spreadsheet and STATA file.
Publications
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.
PubMed 25722595Becker 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.
PubMed 17762286Centeno 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.
PubMed 29177632Cameron JA TK. Autologous Platelet Rich Plasma for Neck and Lower Back Pain Secondary to Spinal Disc Herniation: Midterm Results. Spine Res 2017;32.
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.
PubMed 26713125Wongjarupong 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.
PubMed 37118707
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Platelet-Rich Plasma" Transforaminal Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05234840
- Acronym / sponsor ID
- 015/2563
- Conditions
- PRP
- Keywords
- PRP, HNP, lumbar HNP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone group | Active comparator | Drug: TriamcinolonePatients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy. |
| Platelet-rich plasma | Experimental | Drug: platelet rich plasmaPatients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous spine surgery or epidural injection
- Progressive neurological deficit
- Cauda equina
- Coagulopathy-related conditions
- Associated cervical myelopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmaAlso: PRP1. 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 | Drug | Platelet-rich plasma |
| TriamcinoloneAlso: kenacort40 mg triamcinolone with 1% lidocaine, total of 2 ml | Drug | Triamcinolone group |
Primary outcome
VAS of leg pain
Time frame: at 24 weeks
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
4 secondary outcomes
VAS of back
Time frame: at 24 weeks
ODI
Time frame: at 24 weeks
adverse event
Time frame: up to 24 weeks
Rate of treatment failure [participant who require reinjection or operation]
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 25722595Dhurat 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.
- Background: PubMed 17762286Becker 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.
- Background: PubMed 29177632Centeno 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.
- BackgroundCameron JA TK. Autologous Platelet Rich Plasma for Neck and Lower Back Pain Secondary to Spinal Disc Herniation: Midterm Results. Spine Res 2017;32.
- Background: PubMed 26713125H 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.
- Derived from this study: PubMed 37118707Wongjarupong 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.
- Individual participant dataSharing planned: Undecided. Data was save in form of Microsoft excel spreadsheet and STATA file.
Related trials for PRP
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma and Triamcinolone in people with PRP, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS of leg pain (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234840, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.