Lumbar Disc HerniationNCT05330806
Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation
A study testing Collagenase chemonucleolysis and Percutaneous endoscopic lumbar discectomy (PELD) in people with Lumbar Disc Herniation, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Lumbar disc herniation compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. Both collagenase chemonucleolysis(CCNL) and percutaneous endoscopic lumbar discectomy (PELD) was effective to treat lumbar disc herniation(LDH) requires… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Collagenase chemonucleolysis and Percutaneous endoscopic lumbar discectomy (PELD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 28 Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least six weeks of excessive radiating leg pain with no tendency for any clinical improvement despite conservative therapy
- have a nerve root compression by a lumbar disc herniation proven by magnetic resonance imaging
Who cannot join
- previous surgery at the same or adjacent disc level;
- isthmic or degenerative spondylolisthesis
- pregnancy
- severe comorbid medical or psychiatric disorder (American Society of Anesthesiologists' classification >2);
- severe caudal or cranial sequestration of disc fragments, defined as sequestration towards more than half of the adjacent vertebra;
- contraindication for surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShenzhenPH
Shenzhen, Guangdong, 518000
Hongyu Wang, Doctor, 18241651300, wanghongyu790039663@126.com
About this study
Official title: Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation, a Randomized Controlled Trial
Lumbar disc herniation compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. Both collagenase chemonucleolysis(CCNL) and percutaneous endoscopic lumbar discectomy (PELD) was effective to treat lumbar disc herniation(LDH) requires surgery. whether functional clinical outcomes of CCNL vs PELD effect on LDH was superior, and no study provided convincing evidence.
Read the detailed description
Lumbar disc herniation (LDH) is a common disease with an incidence of 1%-3%, usually manifested as low back pain radiating to the lower extremities, which seriously affects patients' quality of life. Collagen hydrolysis was effective in treating LDH, it makes the protrusion smaller or disappeared, relieving or resolving the compression of nerve root by the protrusion.Percutaneous endoscopic lumbar discectomy (PELD) is a less invasive techniques to treat LDH. However, the outcomes of collagen hydrolysis vs PELD effect was still unknown.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Collagenase chemonucleolysis, Percutaneous endoscopic lumbar discectomy (PELD)
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase chemonucleolysisProcedure or surgery
After local anesthesia, and the puncture point was 8-12cm on the side of the paraspinous process under C arm fluoroscopy. The needle was punctured though the skin with an angle of 45-60 to the posterior of the vertebral via "safe" entry zone to the herniated site outside the intervertebral disc under the epidural space. The syringe was drawn back to confirm that no blood or cerebrospinal fluid was flowing out, Contrast agents were injected to make sure no flows out of the spinal canal. 600 unit collagenase was dissolved in 2ml normal saline and injected slowly with rate of 1ml per minute. The needle was removed and keep the dorsal elevated position for 6-8 hours. Keep away from load bear of lumbar for 3 months.
Percutaneous endoscopic lumbar discectomy (PELD)Procedure or surgery
Also called Percutaneous transforaminal endoscopic discectomy (PTED) for L1-L4 and percutaneous endoscopic interlaminar discectomy(PEID) for L5-S1 lumbar disc herniation
For L1-L4 segment, percutaneous endoscopic transforaminal discectomy(PETD) will be performed. An 1cm length incision was made at 8-14cm lateral of the paraspinous process, where a needle puncture to the superior articular process of the lower involved vertebrae of the herniated disc. A series of conical rods are to be introduced, subsequently a reamer is to be introduced through the cannula. After removal of the disc herniation, the cannula and endoscope are to be removed. For L5/S1 segment, percutaneous endoscopic interlaminar discectomy(PEID) was performed. An incision of nearly 7 mm was made at the entry point of the skin, and a series of expansion channels were sequentially inserted into the surface of the ligamentum flavum.Then, the ligamentum flavum and soft tissue around it were removed. Then, the tongue of the working cannula was inserted and rotated into the lateral nerve root. Removed the prominent nucleus pulposus by various nucleus pulposus forceps.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase chemonucleolysis | Experimental | After local anesthesia, and the puncture point was 8-12cm on the side of the paraspinous process under C arm fluoroscopy. The needle was punctured though the skin with an angle of 45-60 to the posterior of the vertebral via "safe" entry zone to the herniated site outside the intervertebral disc under the epidural space. The syringe was drawn back to confirm that no blood or cerebrospinal fluid was flowing out, Contrast agents were injected to make sure no flows out of the spinal canal. 600 unit collagenase was dissolved in 2ml normal saline and injected slowly with rate of 1ml per minute. The needle was removed and keep the dorsal elevated position for 6-8 hours. Keep away from load bear of lumbar for 3 months. Receives: Procedure: Collagenase chemonucleolysis |
| Percutaneous endoscopic lumbar discectomy (PELD) | Active comparator | For L1-L4 segment, percutaneous endoscopic transforaminal discectomy(PETD) will be performed. An 1cm length incision was made at 8-14cm lateral of the paraspinous process, where a needle puncture to the superior articular process of the lower involved vertebrae of the herniated disc. A series of conical rods are to be introduced, subsequently a reamer is to be introduced through the cannula. After removal of the disc herniation, the cannula and endoscope are to be removed. For L5/S1 segment, percutaneous endoscopic interlaminar discectomy(PEID) was performed. An incision of nearly 7 mm was made at the entry point of the skin, and a series of expansion channels were sequentially inserted into the surface of the ligamentum flavum.Then, the ligamentum flavum and soft tissue around it were removed. Then, the tongue of the working cannula was inserted and rotated into the lateral nerve root. Removed the prominent nucleus pulposus by various nucleus pulposus forceps. Receives: Procedure: Percutaneous endoscopic lumbar discectomy (PELD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale/Score of leg
Visual Analogue Scale pain assess for leg. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Measured: up to 12 months
Visual Analogue Scale/Score of lumbar
Visual Analogue Scale pain assess for lumbar. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Measured: up to 12 months
Recurrence rate
The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.
Measured: up to 12 months
reoperation
The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.
Measured: up to 12 months
Secondary outcomes (10)
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain. The lowest score is 0, the highest 24. The higher the score, the more severe the dysfunction.
Measured: up to 12 month
the EuroQoL-5D (EQ-5D)
EQ-5D descriptive system is a preference-based Health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. From this, a quality of life score can be calculated ranging from -0.594, indicating a health state worse than death where 0 is death, to 1, indicating full health
Measured: up to 12 month
Duration of operation
Duration of operation time： The minimum value is 1 minute, and the maximum value is 120 minutes
Measured: up to 12 month
Length of stay in the hospital
Length of stay in the hospital： The minimum value is 1 day. The maximum value is 30 days
Measured: up to 12 month
Major complications
Major complications includes cerebrospinal fluid leakage,deep venous thrombosis in the leg, transient increase in neurological deficit, repeated surgery,Opioid analgesics
Measured: up to 12 month
hospital fees
hospital fees ：Minimum 500 yuan, maximum 30,000 yuan
Measured: up to 12 month
the Oswestry Disability Index (ODI)
Disability was evaluated using the Oswestry Disability Index (ODI)
Measured: up to 12 month
the Medical Outcomes Study 12-item short-form health survey (SF-12) scale
SF-12 including mental and physical components, was shorter versions of 36-item Short-Form Health Survey (SF-36) to evaluate life quality
Measured: up to 12 month
modified MacNab
modified MacNab criteria is patient satisfaction with excellent outcomes, good, fair, and poor.
Measured: up to 12 month
cost-effectiveness
Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the difference in costs by the difference in effects.
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Jan 2021
- Primary completion25 Jun 2023 (estimated)
- Study completion28 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Songlin Peng, Doctor, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330806
- Sponsor's protocol ID
- ShenzhenPH spine wang05
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibson JN, Cowie JG, Iprenburg M. Transforaminal endoscopic spinal surgery: the future 'gold standard' for discectomy? - A review. Surgeon. 2012 Oct;10(5):290-6. doi: 10.1016/j.surge.2012.05.001. Epub 2012 Jun 15.
PubMed 22705355Yuan P, Shi X, Wei X, Wang Z, Mu J, Zhang H. Development process and clinical application of collagenase chemonucleolysis in the treatment of lumbar disc herniation: a narrative review in China. Postgrad Med J. 2022 Mar 14:postgradmedj-2021-141208. doi: 10.1136/postgradmedj-2021-141208. Online ahead of print.
PubMed 35288448Gadjradj PS, Harhangi BS. Percutaneous Transforaminal Endoscopic Discectomy for Lumbar Disk Herniation. Clin Spine Surg. 2016 Nov;29(9):368-371. doi: 10.1097/BSD.0000000000000366.
PubMed 26945128
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05330806
- Acronym / sponsor ID
- ShenzhenPH spine wang05
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 28 Jun 2023 (estimated)
- First posted
- 15 Apr 2022 (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 compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. Both collagenase chemonucleolysis(CCNL) and percutaneous endoscopic lumbar discectomy (PELD) was effective to treat lumbar disc herniation(LDH) requires surgery. whether functional clinical outcomes of CCNL vs PELD effect on LDH was superior, and no study provided convincing evidence.
Detailed description
Lumbar disc herniation (LDH) is a common disease with an incidence of 1%-3%, usually manifested as low back pain radiating to the lower extremities, which seriously affects patients' quality of life. Collagen hydrolysis was effective in treating LDH, it makes the protrusion smaller or disappeared, relieving or resolving the compression of nerve root by the protrusion.Percutaneous endoscopic lumbar discectomy (PELD) is a less invasive techniques to treat LDH. However, the outcomes of collagen hydrolysis vs PELD effect was still unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase chemonucleolysis | Experimental | Procedure: Collagenase chemonucleolysisAfter local anesthesia, and the puncture point was 8-12cm on the side of the paraspinous process under C arm fluoroscopy. The needle was punctured though the skin with an angle of 45-60 to the posterior of the vertebral via "safe" entry zone to the herniated site outside the intervertebral disc under the epidural space. The syringe was drawn back to confirm that no blood or cerebrospinal fluid was flowing out, Contrast agents were injected to make sure no flows out of the spinal canal. 600 unit collagenase was dissolved in 2ml normal saline and injected slowly with rate of 1ml per minute. The needle was removed and keep the dorsal elevated position for 6-8 hours. Keep away from load bear of lumbar for 3 months. |
| Percutaneous endoscopic lumbar discectomy (PELD) | Active comparator | Procedure: Percutaneous endoscopic lumbar discectomy (PELD)For L1-L4 segment, percutaneous endoscopic transforaminal discectomy(PETD) will be performed. An 1cm length incision was made at 8-14cm lateral of the paraspinous process, where a needle puncture to the superior articular process of the lower involved vertebrae of the herniated disc. A series of conical rods are to be introduced, subsequently a reamer is to be introduced through the cannula. After removal of the disc herniation, the cannula and endoscope are to be removed. For L5/S1 segment, percutaneous endoscopic interlaminar discectomy(PEID) was performed. An incision of nearly 7 mm was made at the entry point of the skin, and a series of expansion channels were sequentially inserted into the surface of the ligamentum flavum.Then, the ligamentum flavum and soft tissue around it were removed. Then, the tongue of the working cannula was inserted and rotated into the lateral nerve root. Removed the prominent nucleus pulposus by various nucleus pulposus forceps. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least six weeks of excessive radiating leg pain with no tendency for any clinical improvement despite conservative therapy
- have a nerve root compression by a lumbar disc herniation proven by magnetic resonance imaging
Key exclusion criteria (6 listed)
- previous surgery at the same or adjacent disc level;
- isthmic or degenerative spondylolisthesis
- pregnancy
- severe comorbid medical or psychiatric disorder (American Society of Anesthesiologists' classification >2);
- severe caudal or cranial sequestration of disc fragments, defined as sequestration towards more than half of the adjacent vertebra;
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 |
|---|---|---|
| Collagenase chemonucleolysisAfter local anesthesia, and the puncture point was 8-12cm on the side of the paraspinous process under C arm fluoroscopy. The needle was punctured though the skin with an angle of 45-60 to the posterior of the vertebral via "safe" entry zone to the herniated site outside the intervertebral disc under the epidural space. The syringe was drawn back to confirm that no blood or cerebrospinal fluid was flowing out, Contrast agents were injected to make sure no flows out of the spinal canal. 600 unit collagenase was dissolved in 2ml normal saline and injected slowly with rate of 1ml per minute. The needle was removed and keep the dorsal elevated position for 6-8 hours. Keep away from load bear of lumbar for 3 months. | Procedure or surgery | Collagenase chemonucleolysis |
| Percutaneous endoscopic lumbar discectomy (PELD)Also: Percutaneous transforaminal endoscopic discectomy (PTED) for L1-L4 and percutaneous endoscopic interlaminar discectomy(PEID) for L5-S1 lumbar disc herniationFor L1-L4 segment, percutaneous endoscopic transforaminal discectomy(PETD) will be performed. An 1cm length incision was made at 8-14cm lateral of the paraspinous process, where a needle puncture to the superior articular process of the lower involved vertebrae of the herniated disc. A series of conical rods are to be introduced, subsequently a reamer is to be introduced through the cannula. After removal of the disc herniation, the cannula and endoscope are to be removed. For L5/S1 segment, percutaneous endoscopic interlaminar discectomy(PEID) was performed. An incision of nearly 7 mm was made at the entry point of the skin, and a series of expansion channels were sequentially inserted into the surface of the ligamentum flavum.Then, the ligamentum flavum and soft tissue around it were removed. Then, the tongue of the working cannula was inserted and rotated into the lateral nerve root. Removed the prominent nucleus pulposus by various nucleus pulposus forceps. | Procedure or surgery | Percutaneous endoscopic lumbar discectomy (PELD) |
Primary outcome
Visual Analogue Scale/Score of leg
Time frame: up to 12 months
Visual Analogue Scale pain assess for leg. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Visual Analogue Scale/Score of lumbar
Time frame: up to 12 months
Visual Analogue Scale pain assess for lumbar. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Recurrence rate
Time frame: up to 12 months
The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.
reoperation
Time frame: up to 12 months
The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.
10 secondary outcomes
The Roland-Morris Disability Questionnaire
Time frame: up to 12 month
the EuroQoL-5D (EQ-5D)
Time frame: up to 12 month
Duration of operation
Time frame: up to 12 month
Length of stay in the hospital
Time frame: up to 12 month
Major complications
Time frame: up to 12 month
hospital fees
Time frame: up to 12 month
the Oswestry Disability Index (ODI)
Time frame: up to 12 month
the Medical Outcomes Study 12-item short-form health survey (SF-12) scale
Time frame: up to 12 month
modified MacNab
Time frame: up to 12 month
cost-effectiveness
Time frame: up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 22705355Gibson JN, Cowie JG, Iprenburg M. Transforaminal endoscopic spinal surgery: the future 'gold standard' for discectomy? - A review. Surgeon. 2012 Oct;10(5):290-6. doi: 10.1016/j.surge.2012.05.001. Epub 2012 Jun 15.
- Background: PubMed 35288448Yuan P, Shi X, Wei X, Wang Z, Mu J, Zhang H. Development process and clinical application of collagenase chemonucleolysis in the treatment of lumbar disc herniation: a narrative review in China. Postgrad Med J. 2022 Mar 14:postgradmedj-2021-141208. doi: 10.1136/postgradmedj-2021-141208. Online ahead of print.
- Background: PubMed 26945128Gadjradj PS, Harhangi BS. Percutaneous Transforaminal Endoscopic Discectomy for Lumbar Disk Herniation. Clin Spine Surg. 2016 Nov;29(9):368-371. doi: 10.1097/BSD.0000000000000366.
- 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.
Songlin Peng, Doctor principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagenase chemonucleolysis and Percutaneous endoscopic lumbar discectomy (PELD) in people with Lumbar Disc Herniation, run by Shenzhen People's Hospital 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 6 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 10 Mar 2023. 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 Hongyu Wang, Doctor (18241651300, wanghongyu790039663@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale/Score of leg (time frame: up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330806, which also lists 3 linked publications.
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 10 Mar 2023.