PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation

NCT03634046 | Unknown DMC

• 2 other identifiers: XJTU1AF-CRF-2016T-1581371987
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation; Chronic Low Back Pain

Keywords

Lumbar Disc Herniation; Low Back Pain; Percutaneous Transforaminal Endoscopic Discectomy; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Changes on the Visual Analogue Scale for Leg Pain

  Draw a line of 100 mm on the paper, the end of the horizontal line is 0, indicating no pain; The other end is 10, which is a very serious pain; The middle section shows varying degrees of pain. Let the patient draw a mark on the horizontal line to indicate the extent of the pain.

  Baseline, 7 days, 1 month, 6 months and 12 months post-operation.

Secondary Outcomes (6)

• Changes on the Oswestry Disability Index (ODI)

  Baseline, 7 days, 1 month, 6 months and 12 months post-operation.

• Changes on 36-Item Short-Form Quality of Life Questionnaire (SF-36)

  Baseline, 7 days, 1 month, 6 months and 12 months post-operation.

• Changes on Burns Depression Checklist

  Baseline, 7 days, 1 month, 6 months and 12 months post-operation.

• Changes on the Visual Analogue Scale for Back Pain

  Baseline, 7 days, 1 month, 6 months and 12 months post-operation.

• Complications

  through study completion, up to 1year of follow-up.

Study Arms (2)

PTED group

EXPERIMENTAL

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: Percutaneous transforaminal endoscopic discectomy; Procedure: Radiofrequency ablation

RA group

ACTIVE COMPARATOR

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.

Procedure: Radiofrequency ablation

Interventions

Percutaneous transforaminal endoscopic discectomy PROCEDURE

The same as the descriptions in experimental group.

PTED group

Radiofrequency ablation PROCEDURE

The same as the descriptions in active comparator group.

PTED group; RA group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

FirstXianJiaotongU

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yingang Zhang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor do not know all the information about the data origin and the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects were recruited comparatively into two groups (percutaneous transforaminal endoscopic discectomy (PTED) group and Radiofrequency Ablation (RA) group). The follow-up time points are 7 days, 1 month, 6 months and 12 months post-operation in both groups, respectively.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 16, 2018
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 26, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)