Lumbar Disc HerniationPTEDNCT03634046
PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation
A study testing Percutaneous transforaminal endoscopic discectomy and Radiofrequency ablation in people with Lumbar Disc Herniation and Chronic Low Back Pain, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation, Chronic Low Back Pain
- What is being tested?
- Percutaneous transforaminal endoscopic discectomy and Radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Please see the Eligibility Criteria or Outcome Measures sections.
- Conditions
- Lumbar Disc Herniation, Chronic Low Back Pain
- Being tested
- Percutaneous transforaminal endoscopic discectomy, Radiofrequency ablation
- Keywords
- Lumbar Disc Herniation, Low Back Pain, Percutaneous Transforaminal Endoscopic Discectomy, Radiofrequency Ablation
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transforaminal endoscopic discectomyProcedure or surgery
The same as the descriptions in experimental group.
Radiofrequency ablationProcedure or surgery
The same as the descriptions in active comparator group.
| Study group | Role | What they receive |
|---|---|---|
| PTED group | Experimental | 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. Receives: Procedure: Percutaneous transforaminal endoscopic discectomy; Procedure: Radiofrequency ablation |
| RA group | Active comparator | 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. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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'.
Measured: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jan 2016
- Primary completion1 Sep 2018 (estimated)
- Study completion26 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingang Zhang, MD, Principal investigator, First Affiliated Hospital, Medical College of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634046
- Sponsor's protocol ID
- XJTU1AF-CRF-2016T-15
- Other IDs
- 81371987
- Acronym
- PTED
- Status last verified
- Aug 2018
- First submitted
- 17 Jul 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03634046
- Acronym / sponsor ID
- PTED / XJTU1AF-CRF-2016T-15
- Conditions
- Lumbar Disc Herniation, Chronic Low Back Pain
- Keywords
- Lumbar Disc Herniation, Low Back Pain, Percutaneous Transforaminal Endoscopic Discectomy, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 26 Sep 2018 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PTED group | Experimental | Procedure: Percutaneous transforaminal endoscopic discectomy, Procedure: Radiofrequency ablationPercutaneous 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. |
| RA group | Active comparator | Procedure: Radiofrequency ablationRadiofrequency 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transforaminal endoscopic discectomyThe same as the descriptions in experimental group. | Procedure or surgery | PTED group |
| Radiofrequency ablationThe same as the descriptions in active comparator group. | Procedure or surgery | PTED group, RA group |
Primary outcome
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.
6 secondary outcomes
Changes on the Oswestry Disability Index (ODI)
Time frame: 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.
Changes on Burns Depression Checklist
Time frame: 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.
Complications
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingang Zhang, MD principal investigator
First Affiliated Hospital, Medical College of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous transforaminal endoscopic discectomy and Radiofrequency ablation in people with Lumbar Disc Herniation and Chronic Low Back Pain, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the Visual Analogue Scale for Leg Pain (time frame: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.