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Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, several minimal invasive surgeries have been uesd widely. Percutaneous lumbar discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and ozone therapy combined other minimally invasive treatment could improve other minimally invasive treatment's clinical effectiveness. The effectiveness of which has been proved to be comparable to conventional open discectomy.
In this study, a single-blind randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.
Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc herniation undergoing PLD.
The primary endpoints of the study will be changes in in pain and functional status by the Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include response evaluation by MacNab response evaluation criteria as measured at pre- and post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference in the mean change from baseline between the two groups.
For the first time,the results of this trial will provide scientific evidence as to the relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical treatment for symptomatic lumbar disc herniation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLD combined with ozone | Experimental | Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy combined with ozone therapy. |
|
| pure PLD | Active Comparator | Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy(PLD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous lumbar discectomy | Procedure | process percutaneous lumbar discectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Visual Analog Scale(VAS) | Baseline, post-op 1 month, 3 months, 6 months | |
| Changes from baseline in Oswestry Low Back Disability Questionnaire(ODI) | Baseline, post-op 1 month, 3 months, 6 months | |
| Changes from baseline in Japanese Orthopaedic Association Scores(JOA) | Baseline, post-op 1 month, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response evaluation measured by MacNab criteria | Response evaluation as measured by MacNab criteria | post-op 1 month, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao-jun Teng, Ph.D,MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital,Southeast University | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ozone therapy | Procedure | percutaneous intradiscal ozone injection |
|
| D013568 | Pathological Conditions, Signs and Symptoms |