PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation

Chronic Low Back Pain Clinical Trial

— PTED  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03634046
• Other study ID #: XJTU1AF-CRF-2016T-15
• Secondary ID: 81371987
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: September 26, 2018

Study information

• Verified date: August 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see the Eligibility Criteria or Outcome Measures sections.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 26, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Hernia
• Low Back Pain
• Lumbar Disc Herniation

Intervention

Procedure:
• Percutaneous transforaminal endoscopic discectomy
The same as the descriptions in experimental group.
• Radiofrequency ablation
The same as the descriptions in active comparator group.

Locations

Country	Name	City	State
China	FirstXianJiaotongU	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.