Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone group | Active Comparator | Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy. |
|
| Platelet-rich plasma | Experimental | Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet rich plasma | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS of leg pain | 0-100 (visual analog score, 0 is the minimum and 100 is the maximum) | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VAS of back | 0-100 (visual analog score, 0 is the minimum and 100 is the maximum) | at 24 weeks |
| ODI | Oswestry Disability Index 0-100% (0 is the minimum and 100 is the maximum) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuenrutai | Chon Buri | 20110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25722595 | Background | 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. | |
| 17762286 | Background | 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. |
Not provided
Not provided
Data was save in form of Microsoft excel spreadsheet and STATA file.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
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.
Not provided
Not provided
all patient were masked. Surgeon was blinded by leukostrip around injection syringe. Assessor was blinded from operative information.
|
|
| Triamcinolone | Drug | 40 mg triamcinolone with 1% lidocaine, total of 2 ml |
|
|
| at 24 weeks |
| adverse event | minor and major complications from injection | 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] | up to 24 weeks |
| 29177632 | Background | 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. |
| Background | Cameron JA TK. Autologous Platelet Rich Plasma for Neck and Lower Back Pain Secondary to Spinal Disc Herniation: Midterm Results. Spine Res 2017;32. |
| 26713125 | Background | 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. |
| 37118707 | Derived | Wongjarupong 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. |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |