Neuralgia, SciaticNCT03511456
An Effect and Safety Observation on PELD Technique for Extraforaminal Disc Herniation at L5/S1
An observational study of Neuralgia, Sciatic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the surgical treatment is still quite challenging. We conducted a modified PELD technique that enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space surrounded by transverse process, facet joint… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Neuralgia, Sciatic
- What is being tested?
- PELD operation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2016to 5 Mar 2022
- Phase
- Observational
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, diagnosed as extraforaminal lumbar disc herniation at L5/S1, and received the operation of percutaneous endoscopic lumbar discectomy
Who may be able to join
- Patients suffered with extraforaminal lumbar disc herniation at L5/S1
- Patients received percutaneous endoscopic lumbar discectomy
Who cannot join
- The diagnosis is not comply with the FLLDH
- patients not choose PELD operation
- patients unwilling to accept regular followup
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Xiaoliang Wu, MD
About this study
Official title: An Effect and Safety Investigation on Percutaneous Endoscopic Lumbar Discectomy Technique to Remove Extraforaminal Disc Herniation at L5/S1 Segment Through 5th Transverse Process-facet Joint-sacrum Space
43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the surgical treatment is still quite challenging. We conducted a modified PELD technique that enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space surrounded by transverse process, facet joint and sacrum (TFS space). This study is to this technique's effect and safety in a one year follow-up.
Read the detailed description
30 cases diagnosed as extraforaminal disc herniation at the segment of Lumbar 5 / sacrum 1 (L5/S1) will be recruited in this investigation. All the patients will receive PELD operation following the strict procedure that penetrating through the TFS space. The pain score (VAS), physical ability (ODI score) and life quality (SF-36） will be evaluated one day before surgery and 2 days, 1 month and 3 months after the surgery. Any side effects such as infection, nerve damage, main blood vessel injury will be recorded.
The operation procedure must follow the following steps:
- The patient was positioned prone.
- The skin entry point was determined using axial MRI or CT images
- During operation, with anterior posterior view of fluoroscopy, the longitudinal midline of lumbar spine on the skin (Line C), the line right across L5/S1 space (Line A) was marked on the skin. With lateral view, the line right across L5/S1 space was also marked on skin (Line B). The line A and B should be crossed. The final entry point on skin was on the Line A and away from midline with the distance measured on axial MRI or CT images as described above.
- Local infiltration with 1% Lidocaine was applied to skin and deep fascia on the penetration path. The introduction of long 20G needles could be performed with continuous or intermittent fluoroscopy. The needle traveled through TFS space. Generally, the position just above S1 superior endplate has enough safe space from the existing nerve root that might be pushed downward by the protruded discs, so it is usually the target for needle puncture. Discography was strongly recommended to confirm diagnosis and distinguish the protruded disc from the surrounding soft tissue.
- The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin at the entry site; a tapered cannulated dilator was inserted along the guide wire; and finally a beveled round working cannula of 8.0 mm in outer diameter was inserted, with the beveled tip touching the endplate of S1 and leaning against superior articular process of S1. If the TFS space is not big enough for working cannula, manual bone drills with blunt tip could be used to enlarge it.
Soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible. Then the disc was removed. An absorbable gelatin sponge was impacted via the working cannula for hemostasis. A sterile dressing was applied with a one-point suture.
- Conditions
- Neuralgia, Sciatic
- Being tested
- PELD operation
- Keywords
- leg pain, waist pain, life quality
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PELD operationProcedure or surgery
Under local anesthesia, the introduction of 20G needles could be performed with fluoroscopy. After the needle traveled through TFS space, extremely care was needed to avoid nerve root injury.
Discography was recommended. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin; a tapered cannulated dilator was inserted along the guide wire; and finally a working cannula was inserted.
The remove of disc was performed carefully under endoscope. The first step was to locate the annulus fibrosis of L5/S1 disc, then by using nerve dissector and bipolar elliquence, soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible and removed.
| Study group | Role | What they receive |
|---|---|---|
| FLLDH-PELD | Extraforaminal LDH patients received PELD operation Receives: Procedure: PELD operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain evaluated by Visual Analogue Scale system. Using a scale ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" and the "agonizing pain" according to the patient's mark, providing a range of scores from 0-10. A higher score means intensifier pain. The effects of operation is based on the different VAS scores evaluated by pre- or post- surgical patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-1), mild pain(2-5), moderate pain (6-8 mm), and severe pain (9-10).
Measured: The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Secondary outcomes (1)
Life quality
SF-36(The Short Form (36) Health Survey), a 36-item, patient-reported survey of patient health will be used for life quality evaluation. it consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). The lower the score the more disability. The higher the score the less disability. The scores are compared pre- and post-operation.
Measured: The change of life quality before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start5 Mar 2016
- Primary completion1 Jul 2021 (estimated)
- Study completion5 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia, SciaticStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dehong Yang, MD,PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511456
- Sponsor's protocol ID
- NFEC-2018-022
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effect and Safety Investigation on Percutaneous Endoscopic Lumbar Discectomy Technique to Remove Extraforaminal Disc Herniation at L5/S1 Segment Through 5th Transverse Process-facet Joint-sacrum Space
- ClinicalTrials.gov ID
- NCT03511456
- Acronym / sponsor ID
- NFEC-2018-022
- Conditions
- Neuralgia, Sciatic
- Keywords
- leg pain, waist pain, life quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 5 Mar 2016 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 5 Mar 2022 (estimated)
- First posted
- 27 Apr 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.
43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the surgical treatment is still quite challenging. We conducted a modified PELD technique that enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space surrounded by transverse process, facet joint and sacrum (TFS space). This study is to this technique's effect and safety in a one year follow-up.
Detailed description
30 cases diagnosed as extraforaminal disc herniation at the segment of Lumbar 5 / sacrum 1 (L5/S1) will be recruited in this investigation. All the patients will receive PELD operation following the strict procedure that penetrating through the TFS space. The pain score (VAS), physical ability (ODI score) and life quality (SF-36） will be evaluated one day before surgery and 2 days, 1 month and 3 months after the surgery. Any side effects such as infection, nerve damage, main blood vessel injury will be recorded.
The operation procedure must follow the following steps:
- The patient was positioned prone.
- The skin entry point was determined using axial MRI or CT images
- During operation, with anterior posterior view of fluoroscopy, the longitudinal midline of lumbar spine on the skin (Line C), the line right across L5/S1 space (Line A) was marked on the skin. With lateral view, the line right across L5/S1 space was also marked on skin (Line B). The line A and B should be crossed. The final entry point on skin was on the Line A and away from midline with the distance measured on axial MRI or CT images as described above.
- Local infiltration with 1% Lidocaine was applied to skin and deep fascia on the penetration path. The introduction of long 20G needles could be performed with continuous or intermittent fluoroscopy. The needle traveled through TFS space. Generally, the position just above S1 superior endplate has enough safe space from the existing nerve root that might be pushed downward by the protruded discs, so it is usually the target for needle puncture. Discography was strongly recommended to confirm diagnosis and distinguish the protruded disc from the surrounding soft tissue.
- The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin at the entry site; a tapered cannulated dilator was inserted along the guide wire; and finally a beveled round working cannula of 8.0 mm in outer diameter was inserted, with the beveled tip touching the endplate of S1 and leaning against superior articular process of S1. If the TFS space is not big enough for working cannula, manual bone drills with blunt tip could be used to enlarge it.
Soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible. Then the disc was removed. An absorbable gelatin sponge was impacted via the working cannula for hemostasis. A sterile dressing was applied with a one-point suture.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLLDH-PELD | – | Procedure: PELD operationExtraforaminal LDH patients received PELD operation |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, diagnosed as extraforaminal lumbar disc herniation at L5/S1, and received the operation of percutaneous endoscopic lumbar discectomy
Key inclusion criteria (2 listed)
- Patients suffered with extraforaminal lumbar disc herniation at L5/S1
- Patients received percutaneous endoscopic lumbar discectomy
Key exclusion criteria (3 listed)
- The diagnosis is not comply with the FLLDH
- patients not choose PELD operation
- patients unwilling to accept regular followup
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 |
|---|---|---|
| PELD operationUnder local anesthesia, the introduction of 20G needles could be performed with fluoroscopy. After the needle traveled through TFS space, extremely care was needed to avoid nerve root injury. Discography was recommended. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin; a tapered cannulated dilator was inserted along the guide wire; and finally a working cannula was inserted. The remove of disc was performed carefully under endoscope. The first step was to locate the annulus fibrosis of L5/S1 disc, then by using nerve dissector and bipolar elliquence, soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible and removed. | Procedure or surgery | FLLDH-PELD |
Primary outcome
Pain score
Time frame: The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Pain evaluated by Visual Analogue Scale system. Using a scale ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" and the "agonizing pain" according to the patient's mark, providing a range of scores from 0-10. A higher score means intensifier pain. The effects of operation is based on the different VAS scores evaluated by pre- or post- surgical patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-1), mild pain(2-5), moderate pain (6-8 mm), and severe pain (9-10).
1 secondary outcome
Life quality
Time frame: The change of life quality before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Dehong Yang, MD,PhD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuralgia, Sciatic, run by Nanfang Hospital, Southern Medical 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 2 inclusion and 3 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 8 Feb 2021. 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?
Contact Dehong Yang, MD, PhD (0118618620087638, drmyang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after 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 8 Feb 2021.