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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain

NCT07036445

Herniated Disc

RECRUITING NA

Safety and Efficacy of PRP for Treatment of Disc Pain

NCT04064866

Discogenic Pain

COMPLETED NA

Platelet-rich Plasma for Low Back Pain

NCT03197415

Discogenic Pain Platelet-rich Plasma

COMPLETED NA

Trial for Treating Painful Degenerative Disc Disease

NCT05287867

Degenerative Disc Disease

RECRUITING NA

Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

NCT01850771

Radiculopathy Herniated Disc Disc Degeneration

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

PRP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

all patient were masked. Surgeon was blinded by leukostrip around injection syringe. Assessor was blinded from operative information.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triamcinolone group

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

Group Type ACTIVE_COMPARATOR

Triamcinolone

Intervention Type DRUG

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

Platelet-rich plasma

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

Group Type EXPERIMENTAL

platelet rich plasma

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Triamcinolone

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRP kenacort

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No