PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation

NCT ID: NCT03634046

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2018-09-26

Brief Summary

Lumbar disc herniation (LDH) is a common and frequently-occurring disease giving rise to low back pain and (or) leg pain. There are about 1.5 million people with LDH-related pain, accounting for 10% of outpatients each year in China. The mechanism of LDH-related pain is that the degeneration causes the protrusion of the intervertebral disc directly to the lower lumbar nerve root or spinal cord, and the chemical stimulation plays a key role in it. Currently, LDH treatments are mainly divided into conservative treatment, surgical treatment and minimally invasive treatment. The minimally invasive technique is a new technology that has been arising in recent years, with small wound, little bleeding and quick recovery. It mainly includes collagenase dissolving, laser decompression, radiofrequency ablation, etc. Intervertebral disc radiofrequency ablation is an early application of minimally invasive technique with a wide range of applications in a long time. The percutaneous transforaminal endoscopic discectomy (PTED) is a new technique, which is applied in clinics with shorter time, and the implementation and efficacy of the technique need to be further discussed. A case-control clinical trial is designed to compare the efficacy and safety of PTED with radiofrequency ablation in the treatment of LDH. Main outcome is Visual Analogue Scale for leg pain, secondary outcomes are Oswestry disability index, quality of life assessment, Burns Depression Checklist, recovery rate, complications, operation time and radiation exposure time, etc. The follow-up time points are 7 days, 1 month, 6 months and 12 months post-operation.

Detailed Description

Please see the Eligibility Criteria or Outcome Measures sections.

Conditions

Lumbar Disc Herniation; Chronic Low Back Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Percutaneous transforaminal endoscopic discectomy

Intervention Type: PROCEDURE

The same as the descriptions in experimental group.

Radiofrequency ablation

Intervention Type: PROCEDURE

The same as the descriptions in active comparator group.

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type: PROCEDURE

The same as the descriptions in active comparator group.

Interventions

Percutaneous transforaminal endoscopic discectomy

The same as the descriptions in experimental group.

Intervention Type: PROCEDURE

Radiofrequency ablation

The same as the descriptions in active comparator group.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Medical College of Xi'an Jiaotong University

Locations

FirstXianJiaotongU

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

81371987

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

XJTU1AF-CRF-2016T-15

Identifier Type: -

Identifier Source: org_study_id