PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation (PTED)

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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Disc Herniation; Chronic Low Back Pain
• Intervention / Treatment: Procedure: Percutaneous transforaminal endoscopic discectomy; Procedure: Radiofrequency ablation

Detailed Description

Please see the Eligibility Criteria or Outcome Measures sections.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • FirstXianJiaotongU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Percutaneous transforaminal endoscopic discectomy; The same as the descriptions in experimental group.; Procedure: Radiofrequency ablation; The same as the descriptions in active comparator 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.	Procedure: Radiofrequency ablation; The same as the descriptions in active comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on the Oswestry Disability Index (ODI)	The ODI was developed by Fairbank to assess functional impairment. There are 10 questions evaluating various daily activities of this scale and 6 options for each question between 0-5. In this scale, the degree of clinical pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel and change degree of the pain are questioned. The minimum score taken from the scale is 0, the maximum score is 50. 0-4 points mean there is no disability, 5-14 points are mild, 15-24 points are moderate, 25-30 points are severe and 35-50 points are considered to be complete functional disability.	Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Changes on 36-Item Short-Form Quality of Life Questionnaire (SF-36)	Short Form-36 (SF-36) will assess the health-related quality of life of individuals. The form consists of a total of 36 articles which can be filed by the patient. The scale consists of 8 subscales related to health. Physical function (10 articles), social function (2 articles), role limitations due to physical problems (3 articles), role limitations due to emotional problems (3 articles), mental health (5 articles), fitness (4 articles), pain (2 articles), general health [general overview point (5 articles) and health change (1 article)]. The scores from each subscale range from 0-100. 0 indicates the worst condition and 100 the best health condition. The SF-36 is suitable for personal evaluation, and can be applied to people over 14 years of age or face to face computerized or trained personnel.	Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Changes on Burns Depression Checklist	List of evaluation index for Burns Depression (Burns' Checklist, business data catalog) and business data catalog including 15 items, each item has four degree options (no, mild, moderate, severe) and, in turn, score of 0, 1, 2, 3 points, and then calculate a score (i.e., Depression index), symptom is heavier, the higher the score. Depression rating: 11 ~ 20 points, mild; 21 ~ 30 minutes, moderate; 31 ~ 45 minutes, heavy. For moderate or severe depression, you need to be treated by a psychiatrist and not be involved in this trial.	Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Changes on the Visual Analogue Scale for Back Pain	The pain intensity in the back will be measured on a scale from 0 (no pain) to 100 mm (worst imaginable pain).	Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Complications	A systematic assessment of complications (including wound infection, deep venous thrombosis, urine tract infection, hematoma, and progressive neurological deficit) will be recorded out by the surgeon and research nurse, and these data are to be extracted from the patient chart. Moreover, surgeons will be asked for perioperative complications.	through study completion, up to 1year of follow-up.
Perceived recovery	To measure the perceived recovery a seven-point Likert scale will be used. The score on this scale vary from 'completely recovered' to 'worse than ever'.	Baseline, 7 days, 1 month, 6 months and 12 months post-operation.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yingang Zhang, MD, First Affiliated Hospital, Medical College of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 26, 2018

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Low Back Pain; Radiofrequency Ablation; Percutaneous Transforaminal Endoscopic Discectomy; Lumbar Disc Herniation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: XJTU1AF-CRF-2016T-15; 81371987 (OTHER_GRANT: Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No