Lumbar Disc HerniationL'DISQNCT05231759
Efficacy of Navigable Percutaneous Plasma Disc Decompression Device (L'DISQ) in Patients With Severe Lumbar Disc Herniation
An observational study of Lumbar Disc Herniation, run by Korea University Anam Hospital.
Trial summary
This study aims to assess the clinical outcome of percutaneous disc decompression using the L'DISQ in patients with severe lumbar disc herniation (LDH). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- L'DISQ
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2009to 31 Mar 2022
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have visited the spine center of Korea University Anam Hospital and received the L'DISQ procedure between March 01, 2009 and February 28, 2019
Who may be able to join
- single-level LDH of MSU classification of grade 3 and refusal of spine surgery
- LBP or lower extremity pain symptoms that persisted for 3 months or more
- unresponsiveness to sufficient conservative treatments, including oral analgesics, physical modalities, or spinal injections (such as selective nerve root blocks)
- limited activities of daily living due to pain.
Who cannot join
- patients lost during the 1-year follow-up
- evidence of peripheral neuropathy on electromyography, which might cause lower extremity pain
- evidence of vertebral fracture in the X-ray analysis
- history of tumor or myelopathy
- history of spinal surgery
- history of coagulopathy
About this study
This study aims to assess the clinical outcome of percutaneous disc decompression using the L'DISQ in patients with severe lumbar disc herniation (LDH).
Read the detailed description
Low back pain (LBP) is one of the most leading cause of chronic pain worldwide and 70-85% of adults have experienced LBP during their lifetime. The one of most common symptom of lumbar disc herniation (LDH) is sciatica, affecting about 1-5% of people worldwide. Almost two thirds of patients suffer from continuous pain even after 12 months of the first episode of LBP. Moreover, such persistent pain reduces the patient's quality of life and increases the social and economic burden due to increased hospital stay and surgical treatment. Traditionally, the primary treatment of LDH is non-surgical treatment including pain medication, rehabilitation exercise, and spinal injection, and about 70% of the patients show improvement of pain within 4 weeks. Surgical treatment is considered if there are neurological symptoms such as bladder dysfunction or progressive muscle weakness, or if symptoms persist for more than 6 weeks despite conservative treatment.
The patients with LDH usually experience sudden onset of LBP with radiating pain to lower extremity. Sensory symptoms such as focal paresis or motor weakness of specific myotome can also occur in the LDH patients. The symptoms and area of pain can vary due to the herniation level and severity. Michigan State University (MSU) classification was often used to evaluate and select for surgical treatment of LDH patients. In this classification, the herniated disc is evaluated using T2 axial magnetic resonance imaging (MRI) scan and classified by its size and location. The size of disc herniation is classified into 1 (*<50% of the distance to the intra-facet line), 2 (intra-facet line>*≥50% of the distance to the intra-facet line), or 3 (beyond intra-facet line). Then the position is classified in to A (central), B (lateral), or C (far lateral). The disc herniations size 3 (beyond intra-facet line) and zone B (lateral) or C (far lateral) are known to have greater impact on nerve compression, which tend to cause worse sciatica and neurologic symptoms and require surgical treatment. Moreover, the patients with larger lumbar disc herniation areas tend to show better outcomes with surgical treatment than conservative treatments and high-grade spinal canal stenosis patients had higher need for surgical treatment.
Over the past few years, various minimally invasive disc decompression procedures, were developed and used in LDH patients. These minimally invasive disc decompression techniques include intradiscal electrothermal therapy, radiofrequency annuloplasy, percutaneous disc decompression, nucleoplasty, and percutaneous laser disc decompression, which caused less damage to spinal structures and reduced tissue destructions than conventional surgical treatments. In particular, nucleoplasty was proven as effective as open discectomy in the treatment of single level lumbar disc herniation. The L'DISQ (U\&I Co., Uijeongbu, Korea) is one of the safe and effective minimally invasive disc decompression procedures which introduced in 2011. In contrast to most percutaneous nucleotomy procedures that used rigid tip, the L'DISQ used a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage.
The L'DISQ can be mainly performed in patients with less severe LDH while surgical treatment was mainly indicated in patients with severe LDH with neurologic symptoms. However, surgical treatment such as lumbar discectomy or spinal fusion increase hospitalization time and may increase financial burden of patients. And spinal fusion surgery might lead to delayed complications such as back muscle weakness or adjacent segment disease. Moreover, patients with severe LDH might refuse or not be able to perform surgery due to medical, financial, or other personal reasons. Recently, studies on the efficacy of L'DISQ or plasma decompression in disc patients are being conducted, and shows similar outcome when compared to surgical treatment in mild to moderate disc herniation patients. However, no studies have been conducted on the efficacy of L'DISQ in patients with severe LDH requiring surgical treatment. Purpose of this study is to report the efficacy of the L'DISQ procedure in patients with severe LDH corresponding to MSU classification 3.
- Conditions
- Lumbar Disc Herniation
- Being tested
- L'DISQ
- Keywords
- Low Back Pain; Percutaneous Decompression; Lumbar Disc Herniation
- 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.
L'DISQDevice
| Study group | Role | What they receive |
|---|---|---|
| Navigable Percutaneous Plasma Disc Decompression (L'DISQ) | The L'DISQ (U\&I Co., Uijeongbu, Korea) is one of the minimally invasive disc decompression procedures which was introduced in 2011. The L'DISQ uses a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage. Receives: Device: L'DISQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
VAS (Visual Analogue Scale) is a measuring tool that can quickly and easily measure the level of pain through the patient's expression or attitude.
Measured: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure.
Secondary outcomes (5)
Straight Leg Raise Test (SLRT)
The SLRT is a test that measures the initial angle at which the patient complains of lower extremity radiating pain during the passive hip flexion with knee extended in supine position. Normal people show hip flexion angle of 80 to 90 degrees, but the hip flexion angle at the initiationg of pain is reduced in LDH patients due to nerve irritation at the level of disc prolapse
Measured: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ is used to evaluate physical disability caused by low back pain and its score range from 0 to 24. The higher score means greater level of disability
Measured: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Oswestry Disability Index (ODI)
The ODI is used to assess chronic low back pain symptoms and is consisted of 10 questions. The ODI score can result from 0 to 100% and higher score also means greater level of disabilities.
Measured: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Physical Component Score (PCS) of Short Form-36 version 2 (SF-36v2)
The PCS is component of SF-36v2. The SF-36v2 is a short-form survey for evaluating health status including physical and mental factors. The PCS shows summary of physical component. It can be scored from 0 to 100 and higher scores indicates better health status.
Measured: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Bodily Pain Score (BPS) of Short Form-36 version 2 (SF-36v2)
The BPS is component of SF-36v2. The SF-36v2 is a short-form survey for evaluating health status including physical and mental factors. The BPS shows summary of bodily pain component. It can be scored from 0 to 100 and higher scores indicates better health status.
Measured: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Mar 2009
- Primary completion28 Feb 2019
- Study completion31 Mar 2022 (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.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231759
- Sponsor's protocol ID
- K2021-2858-001
- Acronym
- L'DISQ
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Navigable Percutaneous Plasma Disc Decompression Device (L'DISQ) in Patients With Severe Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05231759
- Acronym / sponsor ID
- L'DISQ / K2021-2858-001
- Conditions
- Lumbar Disc Herniation
- Keywords
- Low Back Pain; Percutaneous Decompression; Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Mar 2009 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 9 Feb 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.
This study aims to assess the clinical outcome of percutaneous disc decompression using the L'DISQ in patients with severe lumbar disc herniation (LDH).
Detailed description
Low back pain (LBP) is one of the most leading cause of chronic pain worldwide and 70-85% of adults have experienced LBP during their lifetime. The one of most common symptom of lumbar disc herniation (LDH) is sciatica, affecting about 1-5% of people worldwide. Almost two thirds of patients suffer from continuous pain even after 12 months of the first episode of LBP. Moreover, such persistent pain reduces the patient's quality of life and increases the social and economic burden due to increased hospital stay and surgical treatment. Traditionally, the primary treatment of LDH is non-surgical treatment including pain medication, rehabilitation exercise, and spinal injection, and about 70% of the patients show improvement of pain within 4 weeks. Surgical treatment is considered if there are neurological symptoms such as bladder dysfunction or progressive muscle weakness, or if symptoms persist for more than 6 weeks despite conservative treatment.
The patients with LDH usually experience sudden onset of LBP with radiating pain to lower extremity. Sensory symptoms such as focal paresis or motor weakness of specific myotome can also occur in the LDH patients. The symptoms and area of pain can vary due to the herniation level and severity. Michigan State University (MSU) classification was often used to evaluate and select for surgical treatment of LDH patients. In this classification, the herniated disc is evaluated using T2 axial magnetic resonance imaging (MRI) scan and classified by its size and location. The size of disc herniation is classified into 1 (*<50% of the distance to the intra-facet line), 2 (intra-facet line>*≥50% of the distance to the intra-facet line), or 3 (beyond intra-facet line). Then the position is classified in to A (central), B (lateral), or C (far lateral). The disc herniations size 3 (beyond intra-facet line) and zone B (lateral) or C (far lateral) are known to have greater impact on nerve compression, which tend to cause worse sciatica and neurologic symptoms and require surgical treatment. Moreover, the patients with larger lumbar disc herniation areas tend to show better outcomes with surgical treatment than conservative treatments and high-grade spinal canal stenosis patients had higher need for surgical treatment.
Over the past few years, various minimally invasive disc decompression procedures, were developed and used in LDH patients. These minimally invasive disc decompression techniques include intradiscal electrothermal therapy, radiofrequency annuloplasy, percutaneous disc decompression, nucleoplasty, and percutaneous laser disc decompression, which caused less damage to spinal structures and reduced tissue destructions than conventional surgical treatments. In particular, nucleoplasty was proven as effective as open discectomy in the treatment of single level lumbar disc herniation. The L'DISQ (U\&I Co., Uijeongbu, Korea) is one of the safe and effective minimally invasive disc decompression procedures which introduced in 2011. In contrast to most percutaneous nucleotomy procedures that used rigid tip, the L'DISQ used a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage.
The L'DISQ can be mainly performed in patients with less severe LDH while surgical treatment was mainly indicated in patients with severe LDH with neurologic symptoms. However, surgical treatment such as lumbar discectomy or spinal fusion increase hospitalization time and may increase financial burden of patients. And spinal fusion surgery might lead to delayed complications such as back muscle weakness or adjacent segment disease. Moreover, patients with severe LDH might refuse or not be able to perform surgery due to medical, financial, or other personal reasons. Recently, studies on the efficacy of L'DISQ or plasma decompression in disc patients are being conducted, and shows similar outcome when compared to surgical treatment in mild to moderate disc herniation patients. However, no studies have been conducted on the efficacy of L'DISQ in patients with severe LDH requiring surgical treatment. Purpose of this study is to report the efficacy of the L'DISQ procedure in patients with severe LDH corresponding to MSU classification 3.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigable Percutaneous Plasma Disc Decompression (L'DISQ) | – | Device: L'DISQThe L'DISQ (U\&I Co., Uijeongbu, Korea) is one of the minimally invasive disc decompression procedures which was introduced in 2011. The L'DISQ uses a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have visited the spine center of Korea University Anam Hospital and received the L'DISQ procedure between March 01, 2009 and February 28, 2019
Key inclusion criteria (4 listed)
- single-level LDH of MSU classification of grade 3 and refusal of spine surgery
- LBP or lower extremity pain symptoms that persisted for 3 months or more
- unresponsiveness to sufficient conservative treatments, including oral analgesics, physical modalities, or spinal injections (such as selective nerve root blocks)
- limited activities of daily living due to pain.
Key exclusion criteria (6 listed)
- patients lost during the 1-year follow-up
- evidence of peripheral neuropathy on electromyography, which might cause lower extremity pain
- evidence of vertebral fracture in the X-ray analysis
- history of tumor or myelopathy
- history of spinal surgery
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 |
|---|---|---|
| L'DISQ | Device | Navigable Percutaneous Plasma Disc Decompression (L'DISQ) |
Primary outcome
Visual analogue scale (VAS)
Time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure.
VAS (Visual Analogue Scale) is a measuring tool that can quickly and easily measure the level of pain through the patient's expression or attitude.
5 secondary outcomes
Straight Leg Raise Test (SLRT)
Time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Oswestry Disability Index (ODI)
Time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Physical Component Score (PCS) of Short Form-36 version 2 (SF-36v2)
Time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Bodily Pain Score (BPS) of Short Form-36 version 2 (SF-36v2)
Time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, run by Korea University Anam Hospital.
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 4 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual analogue scale (VAS) (time frame: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure.). 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 9 Feb 2022.