PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation
Keywords
Abstract
Description
Please see the Eligibility Criteria or Outcome Measures sections.
Dates
| Last Verified: | 07/31/2018 |
| First Submitted: | 07/16/2018 |
| Estimated Enrollment Submitted: | 08/13/2018 |
| First Posted: | 08/15/2018 |
| Last Update Submitted: | 08/13/2018 |
| Last Update Posted: | 08/15/2018 |
| Actual Study Start Date: | 12/31/2015 |
| Estimated Primary Completion Date: | 08/31/2018 |
| Estimated Study Completion Date: | 09/25/2018 |
Condition or disease
Intervention/treatment
Procedure: PTED group
Procedure: Radiofrequency ablation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: PTED group Percutaneous transforaminal endoscopic discectomy (PTED). Use German Joimax company production of intervertebral foramen mirror operation system, the prone position, by preoperative X-ray locating the skin into the needle point, intervertebral level away from the spine line 8 ~ 10 cm, 18 g needle insertion, the Kambin security triangle directly through the middle of pathological changes of intervertebral disc. After the success of the puncture, remove the needle core, injection of contrast agent, methylene blue (9:1) mixture disk imaging, replace the godet, slight rotation step by step to insert the expansion sleeve, X-ray perspective to determine work under the correct position. Radiofrequency ablation is used to form nucleus pulposus and fibrous ring and stop bleeding. | Procedure: PTED group The same as the descriptions in experimental group. |
| Active Comparator: RA group Radiofrequency ablation (RA). Patients in prone position, local infiltration anesthesia, the puncture point for lesion clearance level, is apart from the spine line distance is 8 to 10 cm, in the perspective of the C-shaped arm X-ray machine; After the puncture needle was reached, the needle core was removed and the radiofrequency head was pierced through the puncture channel to the nucleus pulposus. In accordance with the method of melt into the shrinking exit, the intensity of the treatment by band 2, increased to 3 file again, according to the needle round mouth of 2, 4, 6, 8, 10, 12 o'clock to this process is repeated six times. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Lumbar intervertebral disc herniation has been treated with conservative treatment of > for 3 months, or can only temporarily improve symptoms to relieve pain, but can not be maintained for a long time, aged between 18 and 60; - The symptoms and signs of lumbar intervertebral disc herniation are obviously consistent with those of CT or MRI; - The protrusion size was < 8.0mm, and imaging examination showed the protrusion of intervertebral disc, mild or moderate protrusion, without calcification, dissociation, and osseous spinal stenosis; - Patients have a strong desire to treat, and understand radiofrequency thermal coagulation ablation and intervertebral endoscopic treatment of possible risk patients; - Conservative treatment is ineffective and the surgical treatment is rejected. Exclusion Criteria: - The non-inclusion or prominent calcification, dissociation, dissociation and consolidation of vertebral canal stenosis or caudal syndrome in the rupture of the fibrous ring and posterior longitudinal ligament; - Patients with spinal fractures, tumors and intervertebral discs have skin infections that affect the puncture; - The combination of mental illness or cognitive dysfunction; - Patients with serious diseases such as active tuberculosis or heart, lung, liver and kidney; - Abnormal bleeding or coagulation function caused by various reasons; - Menstrual period and lactation period; - No informed consent is signed. |
Outcome
Primary Outcome Measures
1. Changes on the Visual Analogue Scale for Leg Pain [Baseline, 7 days, 1 month, 6 months and 12 months post-operation.]
Secondary Outcome Measures
1. Changes on the Oswestry Disability Index (ODI) [Baseline, 7 days, 1 month, 6 months and 12 months post-operation.]
2. Changes on 36-Item Short-Form Quality of Life Questionnaire (SF-36) [Baseline, 7 days, 1 month, 6 months and 12 months post-operation.]
3. Changes on Burns Depression Checklist [Baseline, 7 days, 1 month, 6 months and 12 months post-operation.]
4. Changes on the Visual Analogue Scale for Back Pain [Baseline, 7 days, 1 month, 6 months and 12 months post-operation.]
5. Complications [through study completion, up to 1year of follow-up.]
6. Perceived recovery [Baseline, 7 days, 1 month, 6 months and 12 months post-operation.]
