Clinical trial NCT03634046: PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation
Official title: Efficacy and Safety of Percutaneous Transforaminal Endoscopic Discectomy Versus Radiofrequency Ablation in the Treatment of Lumbar Intervertebral Disc Herniation: a Case-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Chronic Low Back Pain
Keywords: Lumbar Disc Herniation
Low Back Pain
Percutaneous Transforaminal Endoscopic Discectomy
Radiofrequency Ablation
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes on the Visual Analogue Scale for Leg Pain
timeFrame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Secondary outcomes:
measure: Changes on the Oswestry Disability Index (ODI)
timeFrame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
measure: Changes on 36-Item Short-Form Quality of Life Questionnaire (SF-36)
timeFrame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
measure: Changes on Burns Depression Checklist
timeFrame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
measure: Changes on the Visual Analogue Scale for Back Pain
timeFrame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
measure: Complications
timeFrame: through study completion, up to 1year of follow-up.
measure: Perceived recovery
timeFrame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: FirstXianJiaotongU
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital, Medical College of Xi'an Jiaotong University
name: Yingang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: