Lumbar Disc HerniationPhase 3NCT02372032
A Trial of Percutaneous Lumbar Discectomy Combined With Ozone for Treatment of LDH
A Phase 3 study testing percutaneous lumbar discectomy and ozone therapy in people with Lumbar Disc Herniation, run by Zhongda Hospital at 1 site in China.
Trial summary
Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, several minimal invasive surgeries have been uesd widely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- percutaneous lumbar discectomy and ozone therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Sep 2016
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years.
- 4 or more weeks low back pain and/or lower-limb radiation pain.
- MRI and/or CT test confirm diagnosis lumbar disc herniation and level(s).
- Invalid after Non-steroidal anti-inflammatory medical therapy and physical therapy.
- Pain level（Visual Analog Scale）≥5.
Who cannot join
- Spinal tumors.
- Spine infections, fractures, slippage(more than I °) and other deformities.
- Combining with spinal stenosis, lateral recess stenosis, yellow ligament hypertrophy.
- Nucleus pulposus herniated too much, dural sac compressed more than 50%;
- Psychological, cognitive disorders which may affect the reliability of the outcome;
- Previous lumbar disc surgery;
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- Bleeding tendency or severe cardiovascular disease can not tolerate surgery;
- Don't accept the trial's informed consent;
- Possible pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Lumbar Discectomy (PLD) Combined With Ozone Versus Percutaneous Lumbar Discectomy (PLD) for Treatment of Lumbar Disc Herniation:A Single-Blind Prospective Randomized Controlled Trial
Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, several minimal invasive surgeries have been uesd widely. Percutaneous lumbar discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and ozone therapy combined other minimally invasive treatment could improve other minimally invasive treatment's clinical effectiveness. The effectiveness of which has been proved to be comparable to conventional open discectomy.
In this study, a single-blind randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.
Read more
Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc herniation undergoing PLD.
The primary endpoints of the study will be changes in in pain and functional status by the Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include response evaluation by MacNab response evaluation criteria as measured at pre- and post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference in the mean change from baseline between the two groups.
For the first time,the results of this trial will provide scientific evidence as to the relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical treatment for symptomatic lumbar disc herniation.
- Conditions
- Lumbar Disc Herniation
- Being tested
- percutaneous lumbar discectomy, ozone therapy
- Keywords
- Herniation, Discectomy, Ozone
- Medical subject headings
- Intervertebral Disc Displacement, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous lumbar discectomyProcedure or surgery
process percutaneous lumbar discectomy
ozone therapyProcedure or surgery
percutaneous intradiscal ozone injection
| Study group | Role | What they receive |
|---|---|---|
| PLD combined with ozone | Experimental | Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy combined with ozone therapy. Receives: Procedure: percutaneous lumbar discectomy; Procedure: ozone therapy |
| pure PLD | Active comparator | Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy(PLD). Receives: Procedure: percutaneous lumbar discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Visual Analog Scale(VAS)
Measured: Baseline, post-op 1 month, 3 months, 6 months
Changes from baseline in Oswestry Low Back Disability Questionnaire(ODI)
Measured: Baseline, post-op 1 month, 3 months, 6 months
Changes from baseline in Japanese Orthopaedic Association Scores(JOA)
Measured: Baseline, post-op 1 month, 3 months, 6 months
Secondary outcomes (1)
Response evaluation measured by MacNab criteria
Response evaluation as measured by MacNab criteria
Measured: post-op 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-jun Teng, Ph.D,MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372032
- Sponsor's protocol ID
- 2014ZDSYLL134
- Status last verified
- Jul 2016
- First submitted
- 6 Feb 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Lumbar Discectomy (PLD) Combined With Ozone Versus Percutaneous Lumbar Discectomy (PLD) for Treatment of Lumbar Disc Herniation:A Single-Blind Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02372032
- Acronym / sponsor ID
- 2014ZDSYLL134
- Conditions
- Lumbar Disc Herniation
- Keywords
- Herniation, Discectomy, Ozone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 Feb 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.
Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, several minimal invasive surgeries have been uesd widely. Percutaneous lumbar discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and ozone therapy combined other minimally invasive treatment could improve other minimally invasive treatment's clinical effectiveness. The effectiveness of which has been proved to be comparable to conventional open discectomy.
In this study, a single-blind randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.
Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc herniation undergoing PLD.
The primary endpoints of the study will be changes in in pain and functional status by the Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include response evaluation by MacNab response evaluation criteria as measured at pre- and post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference in the mean change from baseline between the two groups.
For the first time,the results of this trial will provide scientific evidence as to the relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical treatment for symptomatic lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLD combined with ozone | Experimental | Procedure: percutaneous lumbar discectomy, Procedure: ozone therapyPatients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy combined with ozone therapy. |
| pure PLD | Active comparator | Procedure: percutaneous lumbar discectomyPatients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy(PLD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age older than 18 years.
- 4 or more weeks low back pain and/or lower-limb radiation pain.
- MRI and/or CT test confirm diagnosis lumbar disc herniation and level(s).
- Invalid after Non-steroidal anti-inflammatory medical therapy and physical therapy.
- Pain level（Visual Analog Scale）≥5.
Key exclusion criteria (9 listed)
- Spinal tumors.
- Spine infections, fractures, slippage(more than I °) and other deformities.
- Combining with spinal stenosis, lateral recess stenosis, yellow ligament hypertrophy.
- Nucleus pulposus herniated too much, dural sac compressed more than 50%;
- Psychological, cognitive disorders which may affect the reliability of the outcome;
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 lumbar discectomyprocess percutaneous lumbar discectomy | Procedure or surgery | PLD combined with ozone, pure PLD |
| ozone therapypercutaneous intradiscal ozone injection | Procedure or surgery | PLD combined with ozone |
Primary outcome
Changes from baseline in Visual Analog Scale(VAS)
Time frame: Baseline, post-op 1 month, 3 months, 6 months
Changes from baseline in Oswestry Low Back Disability Questionnaire(ODI)
Time frame: Baseline, post-op 1 month, 3 months, 6 months
Changes from baseline in Japanese Orthopaedic Association Scores(JOA)
Time frame: Baseline, post-op 1 month, 3 months, 6 months
1 secondary outcome
Response evaluation measured by MacNab criteria
Time frame: post-op 1 month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Gao-jun Teng, Ph.D,MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing percutaneous lumbar discectomy and ozone therapy in people with Lumbar Disc Herniation, run by Zhongda 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 5 inclusion and 9 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 13 Jul 2016. 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.
What does this phase mean?
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?
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 from baseline in Visual Analog Scale(VAS) (time frame: Baseline, post-op 1 month, 3 months, 6 months). The study lists 3 primary outcomes in all. 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 13 Jul 2016.