Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 10:29 PM
Study NCT ID:
NCT02372032
Status:
UNKNOWN
Last Update Posted:
2016-07-13
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Percutaneous Lumbar Discectomy Combined With Ozone for Treatment of LDH
Sponsor:
Zhongda Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: