PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation (PTED)

August 14, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Please see the Eligibility Criteria or Outcome Measures sections.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes on the Visual Analogue Scale for Leg Pain
Time Frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes on the Oswestry Disability Index (ODI)
Time Frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
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)
Time Frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
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
Time Frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
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
Time Frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
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
Time Frame: through study completion, up to 1year of follow-up.
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
Time Frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yingang Zhang, MD, First Affiliated Hospital, Medical College of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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