Studying the effect and safety of percutaneous endoscopy operation combined with platelet-rich plasma injection for treating lumbar disc herniation in young and middle-aged
| ISRCTN | ISRCTN40407546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40407546 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Zhongshan Science and Technology Bureau |
| Funder | Zhongshan Science and Technology Bureau |
- Submission date
- 14/08/2024
- Registration date
- 05/09/2024
- Last edited
- 04/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Lumbar disc herniation (LDH) is a spinal condition where part of a disc in the lower back pushes out and presses on nearby nerves. Percutaneous endoscopic lumbar discectomy (surgery to remove part of the herniated disc) has become widely used for LDH due to its significant advantages and is now the preferred surgical method for simple LDH. While effective in nerve decompression, it lacks methods for repairing the degenerated discs. Platelet-rich plasma (PRP), rich in various growth factors, has shown good potential for disc repair. Currently, there are few clinical studies combining percutaneous endoscopic surgery with PRP for treating LDH. The aim of this study is to assess the clinical effectiveness and safety of percutaneous endoscopic nucleotomy combined with PRP injection for treating LDH in young and middle-aged adults.
Who can participate?
Patients aged 18-55 years with LDH that is unresponsive to 1 month of conservative treatment
What does the study involve?
The patients were randomly divided into observation and control groups. The observation group underwent percutaneous endoscopic nucleotomy combined with PRP gel injection into the disc, while the control group underwent percutaneous endoscopic nucleotomy only.
What are the possible benefits and risks of participating?
Spinal endoscopic nucleotomy with PRP injection provides minimally invasive nerve decompression and promotes tissue repair, leveraging the advantages of both treatment methods. The possible risks are infection and increased surgical costs.
Where is the study run from?
Zhongshan Torch Development Zone People΄s Hospital (China)
When is the study starting and how long is it expected to run for?
January 2022 to December 2024
Who is funding the study?
Zhongshan City Science and Technology Bureau (China)
Who is the main contact?
Hairu Qi, qhr10363@163.com
Contact information
Public, Scientific, Principal investigator
Dept of Orthopaedic
Zhongshan Torch Development Zone People΄s Hospital
Zhongshan
528437
China
| Phone | +86 (0)13549845311 |
|---|---|
| qhr10363@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center single-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Percutaneous endoscopic nucleotomy combined with platelet-rich plasma injection for treating lumbar disc herniation in young and middle-aged |
| Study objectives | The effect of percutaneous spinal endoscopy in the treatment of lumbar disc herniation (LDH) is positive. It is effective for nerve decompression, but there is no good repair method for degenerative intervertebral discs. Platelet-rich plasma (PRP) has a good effect on intervertebral disc repair because it is rich in various growth factors. At present, there are few clinical studies on the treatment of LDH by percutaneous endoscopic spine surgery combined with PRP. This study aims to observe the clinical efficacy and safety of spinal endoscopic surgery combined with PRP in the treatment of LDH. Better results are expected. |
| Ethics approval(s) |
Approved 27/01/2022, Medical ethics committee of Zhongshan Torch Development Zone People΄s Hospital (No. 123 Yixian Road, Torch Development Zone, Zhongshan, 528437, China; +86 (0)760 28106091; 1649328315@qq.com), ref: (2022)-0001 |
| Health condition(s) or problem(s) studied | Lumbar disc herniation |
| Intervention | From April 2022 to December 2023, 60 patients with LDH were randomly divided using the random number table method into two groups of 30 each. The observation group underwent percutaneous endoscopic nucleotomy combined with autologous PRP gel injection into the disc, while the control group underwent percutaneous endoscopic nucleotomy alone. Visual Analogue Scale (VAS) scores and Oswestry Disability Index (ODI) scores were recorded and compared preoperatively, 3 days postoperatively, 3 months postoperatively, and 6 months postoperatively. The modified Macnab criteria were used for efficacy evaluation at the final follow-up. MRI Pfirrmann grading of the operated disc segment and complications were also assessed preoperatively and at the final follow-up. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Pain intensity measured using the Visual Analogue Scale (VAS) preoperatively, 3 days postoperatively, 3 months postoperatively, and 6 months postoperatively |
| Key secondary outcome measure(s) |
1. Pfirrmann grading of the operated disc segment using MRI preoperatively and 6-9 months postoperatively |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Age 18-55 years 2. Diagnosed with LDH, with significant radicular symptoms and positive straight leg raise test, unresponsive to 1 month of conservative treatment 3. Single-segment responsible for surgery |
| Key exclusion criteria | 1. Lumbar infection, tumors, or severe deformities, lumbar instability or spondylolisthesis 2. Blood system-related diseases 3. History of long-term treatment with NSAIDs or immunosuppressants before surgery 4. Significant calcification or bony stenosis of the responsible lumbar disc 5. Psychiatric disorders that prevent full cooperation with treatment |
| Date of first enrolment | 01/04/2022 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Torch Development Zone
Zhongshan
528437
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Datasets generated and/or analyzed during the current study will be available upon request from Hairu Qi, qhr10363@163.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/08/2024: Study's existence confirmed by the medical ethics committee of Zhongshan Torch Development Zone People΄s Hospital.
