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Efficacy Analysis of Collagenase Chemonucleolysis Combined with Platelet-Rich Plasma Injection for Lumbar Disc Herniation

Efficacy Analysis of Collagenase Chemonucleolysis Combined with Platelet-Rich Plasma Injection for Lumbar Disc Herniation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064701
Enrollment
Unknown
Registered
2022-10-14
Start date
2022-10-14
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lumbar disc herniation

Interventions

Group T:collagenase +PRP
Group C:collagenase

Sponsors

Shanghai Pudong Hospital; Fudan University Pudong Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. meeting the diagnostic criteria of LDH; 2. symptoms of low back pain with unilateral limb radicular pain,VAS>=40mm,and had failed to conservative treatment for 6 weeks; 3. preoperative MRI showing patients with single-level disc herniation (L4-L5 or L5-S1),or only single segment needing surgery, which was consistent with clinical symptoms and signs; 4. patients aged 18-70 years old, with BMI 18.5-35kg/m2.

Exclusion criteria

Exclusion criteria: 1. size of disc herniation>10mm,with calcification, dissociation or prolapse; 2. spinal surgery history, intraspinal occupation, severe posterior longitudinal ligament calcification, grade II and above lumbar spondylolisthesis, and lumbar spinal stenosis; 3. severe neurological damagelike spinal cord degeneration, dyskinesia or cauda equina syndrome,etc; 4. allergy to collagenase or other therapeutic drugs; 5. PLT < 150×109/L, bleeding and coagulation dysfunction, or being treated with anticoagulation; 6. puncture contraindications like serious systemic diseases, mental disorders or infection,etc; 7. unable to cooperate to complete the operation, follow-up and functional training.

Design outcomes

Primary

MeasureTime frame
Oswestry disability index;

Secondary

MeasureTime frame
Visual analogue scale;Medical outcomes study 36-item short form health survey;Japanese orthopaedic association (JOA) scores;recurrence Rate;imaging data;

Countries

China

Contacts

Public ContactZhilin Ni

Shanghai Pudong Hospital

283179866@qq.com+86 15651352886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026