lumbar disc herniation(No symptoms of lower extremity nerve roots),Discogenic low back pain
Conditions
Interventions
Treatment Group 1 (Low-dose group):Dissolve collagenase 600U with 6ml sodium chloride injection, and take 1ml for injection
Treatment Group 2 (High-dose group):Dissolve collagenase 600U with 3ml sodium chloride injection, and take 1ml for injection
Control Group:Compound Betamethasone Injection 1ml: Betamethasone dipropionate (measured by Betamethasone) 5mg and Betamethasone sodium phosphate (measured by Betamethasone) 2mg.
Sponsors
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: According to the 2022 Chinese Expert Consensus on the Clinical Application of Lumbar Intervertebral Disc collagenase lysis, indications of collagenase lysis are: 1. Clinical symptoms, signs, MRI and other images showed that the diagnosis was discogenic lumbago, lumbar disc herniation and no obvious symptoms of lower extremity nerve roots (VAS score was less than 3). 2. Patients with poor effect after 1 ~ 4 weeks of non-surgical treatment and informed consent to receive treatment; 3. Age = 18 years old =75 years old; 4. Volunteer to participate in the study and sign the informed consent. If the subject has no ability to read the informed consent (e.g., illiterate subjects), a witness shall witness the informed process and sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with spinal cord degeneration or obvious spinal cord and cauda equina injury; 2. Patients with bone spinal canal or foraminal stenosis; 3. Lumbar instability or spondylolisthesis; 4. Calcification or ossification of the protrusion or posterior longitudinal ligament; 5. Allergic to collagenase; 6. People with coagulation disorders; 7. The presence of uncontrolled infectious diseases; 8. Vulnerable groups in addition to illiteracy, including those with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, etc.; 9. The investigator assessed other conditions that were not suitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Index of Herniated disc; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score;Lumbar and leg pain scores (JOA);Quality of life Score(SF-36);Recurrence rate;Outcome of Image; | — |
Countries
China
Contacts
Public ContactChao Jiang
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed