NCT03634046

PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation

Efficacy and Safety of Percutaneous Transforaminal Endoscopic Discectomy Versus Radiofrequency Ablation in the Treatment of Lumbar Intervertebral Disc Herniation: a Case-control Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Percutaneous transforaminal endoscopic discectomy	The same as the descriptions in experimental group.
PROCEDURE	Radiofrequency ablation	The same as the descriptions in active comparator group.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-09-01
• Completion: 2018-09-26
• First posted: 2018-08-16
• Last updated: 2018-08-16

Locations

1 site across 1 country: China