A Trial of Percutaneous Lumbar Discectomy Combined With Ozone for Treatment of LDH

July 12, 2016 updated by: Gao-jun Teng, Zhongda Hospital

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital,Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Bleeding tendency or severe cardiovascular disease can not tolerate surgery;
  • Don't accept the trial's informed consent;
  • Possible pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLD combined with ozone
Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy combined with ozone therapy.
Procedure: percutaneous lumbar discectomy
process percutaneous lumbar discectomy
Procedure: ozone therapy
percutaneous intradiscal ozone injection
Active Comparator: pure PLD
Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy(PLD).
Procedure: percutaneous lumbar discectomy
process percutaneous lumbar discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in Visual Analog Scale(VAS)
Time Frame: Baseline, post-op 1 month, 3 months, 6 months
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
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
Baseline, post-op 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response evaluation measured by MacNab criteria
Time Frame: post-op 1 month, 3 months, 6 months
Response evaluation as measured by MacNab criteria
post-op 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 21, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014ZDSYLL134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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