Lumbar Herniated Intervertebral DiscPhase 2/3NCT02598232
The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient
A Phase 2/3 study testing 1,414nm Nd:YAG Laser System in people with Lumbar Herniated Intervertebral Disc, run by CynosureLutronic.
Trial summary
This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Lumbar Herniated Intervertebral Disc
- What is being tested?
- 1,414nm Nd:YAG Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2015
- Phase
- Phase 2/3
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 19-79 years old
- Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks
- Patients who have language skills enough to answer questionnaires
- Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study
Who cannot join
- Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc
- Patients who use an electronic medical device for their cardiovascular system
- Patients who have spondylolisthesis in the relevant lesion
- Patients with neurological defects
- Patients who had undergone surgery on the relevant lumbar vertebra
- Patients with cauda equina syndrome
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- Patients with congenital spinal deformity
- Patients with spinal fracture
- Patients with spinal infection, tumor, or other form of inflammatory spondylopathy
- Patients with coagulation disorder
- Patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years)
- Patients who had participated in another clinical study within 30 days from their screening visit
- Female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method* for up to 24 weeks after the use of the investigational medical device during this study
- Medically acceptable contraceptive method: Condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc.
- Patients who are pregnant or breastfeeding
- Other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment
About this study
Official title: A 24-week, Single-center, Open-label, Clinical Study to Evaluate the Efficacy and Safety of the 1,414nm Nd:YAG Laser System Added to PEN to Further Alleviate Back Pain in a Lumbar Herniated Intervertebral Disc Patient
This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.
- Conditions
- Lumbar Herniated Intervertebral Disc
- Being tested
- 1,414nm Nd:YAG Laser System
- 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.
1,414nm Nd:YAG Laser SystemDevice
It has high absorption coefficient in water and a short pulse width.
| Study group | Role | What they receive |
|---|---|---|
| 1,414nm Nd:YAG laser | Experimental | It has high absorption coefficient in water and a short pulse width. Receives: Device: 1,414nm Nd:YAG Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Oswestry Disability Index
Measured: Day 0, 24 weeks
Secondary outcomes (4)
Change in the Oswestry Disability Index
Measured: Day 0, 4 weeks, 12 weeks
Change in the Visual Analogue Scale
Measured: Day 0, 4 weeks, 12 weeks, 24 weeks
12-Item Short-form Health Survey
Measured: Day 0, 4 weeks, 12 weeks, 24 weeks
Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria
Measured: Day 0, 4 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Herniated Intervertebral DiscStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keung-nyun Kim, Professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598232
- Sponsor's protocol ID
- LU-DL-14-001
- Status last verified
- Apr 2016
- First submitted
- 4 Nov 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Single-center, Open-label, Clinical Study to Evaluate the Efficacy and Safety of the 1,414nm Nd:YAG Laser System Added to PEN to Further Alleviate Back Pain in a Lumbar Herniated Intervertebral Disc Patient
- ClinicalTrials.gov ID
- NCT02598232
- Acronym / sponsor ID
- LU-DL-14-001
- Conditions
- Lumbar Herniated Intervertebral Disc
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Nov 2015 (estimated)
- 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 evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1,414nm Nd:YAG laser | Experimental | Device: 1,414nm Nd:YAG Laser SystemIt has high absorption coefficient in water and a short pulse width. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients 19-79 years old
- Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks
- Patients who have language skills enough to answer questionnaires
- Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study
Key exclusion criteria (16 listed)
- Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc
- Patients who use an electronic medical device for their cardiovascular system
- Patients who have spondylolisthesis in the relevant lesion
- Patients with neurological defects
- Patients who had undergone surgery on the relevant lumbar 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 |
|---|---|---|
| 1,414nm Nd:YAG Laser SystemIt has high absorption coefficient in water and a short pulse width. | Device | 1,414nm Nd:YAG laser |
Primary outcome
Change in the Oswestry Disability Index
Time frame: Day 0, 24 weeks
4 secondary outcomes
Change in the Oswestry Disability Index
Time frame: Day 0, 4 weeks, 12 weeks
Change in the Visual Analogue Scale
Time frame: Day 0, 4 weeks, 12 weeks, 24 weeks
12-Item Short-form Health Survey
Time frame: Day 0, 4 weeks, 12 weeks, 24 weeks
Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria
Time frame: Day 0, 4 weeks, 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- 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.
Keung-nyun Kim, Professor principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1,414nm Nd:YAG Laser System in people with Lumbar Herniated Intervertebral Disc, run by CynosureLutronic.
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 16 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: finished, as of the sponsor's last update on 9 Mar 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the Oswestry Disability Index (time frame: Day 0, 24 weeks). 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 Mar 2017.