Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT04414592
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-60 years old;
2. Symptoms with lower back pain and unilateral radicular pain;
3. Failure of conservative treatments including physical therapy, manipulation therapy and non-morphine drug therapy;
4. CT/MRI clearly showing unilateral nucleus pulposus herniation to compress the nerve root;
5. Symptoms and imaging showing unilateral lumbar disc herniation;
6. Imaging showed single-segment lumbar disc herniation;
7. Pfirrmann disc degeneration classification from lumbar MRI: grade I-IV;
8. Segments of lumbar disc herniation: L3-4, L4-5, L5-S1;
9. Unilateral full endoscopic lumbar discectomy;
10. Signing the informed consent;
11. No previous history of spinal surgery.
Exclusion Criteria:
1. Previous history of tumor or spinal infection;
2. Severe coagulation disorders or are taking oral anticoagulants
3. coma or incapacity;
4. MRI contraindications (cardiovascular and cerebrovascular stent implantation history, cardiac pacemaker, biological stimulator, etc.);
5. pregnant;
6. pregnancy or breastfeeding;
7. participated in other clinical trials in the past 30 days;
8. History of stem cell therapy;
9. poor compliance, or inability to properly understand the coordination;
10. received intervertebral disc interventional therapy, such as radiofrequency, laser ablation, protease injection and ozone injection in the past 3 months;
11. Highly allergic constitution or severe allergic history;
12. Severe autoimmune diseases or receiving immunosuppressive therapy;
13. Severe infection or high fever;
14. Shock, failure of vital organs or unstable vital signs;
15. X-ray showing that the stenosis percentage of the degenerative segment was larger than 30% compared to that of the adjacent normal segment.
16. Lumbar disc herniation with calcification;
17. Lumbar disc herniation with Modic Change;
18. Lumbar disc herniation with severe spinal stenosis;
19. Lumbar disc herniation with lumbar spondylolisthesis;
20. Lumbar disc herniation with spinal deformity;
21. psychosocial abnormalities, cognitive impairment, or other physical diseases affecting the research results;
22. Other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04414592
Study Brief:
Protocol Section:
NCT04414592