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

NCT02372032 | Unknown Phase 3

• 1 other identifier: 2014ZDSYLL134
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Herniation; Discectomy; Ozone

Outcome Measures

Primary Outcomes (3)

• Changes from baseline in Visual Analog Scale(VAS)

  Baseline, post-op 1 month, 3 months, 6 months

• Changes from baseline in Oswestry Low Back Disability Questionnaire(ODI)

  Baseline, post-op 1 month, 3 months, 6 months

• Changes from baseline in Japanese Orthopaedic Association Scores(JOA)

  Baseline, post-op 1 month, 3 months, 6 months

Secondary Outcomes (1)

• Response evaluation measured by MacNab criteria

  post-op 1 month, 3 months, 6 months

Study Arms (2)

PLD combined with ozone

EXPERIMENTAL

Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy combined with ozone therapy.

Procedure: percutaneous lumbar discectomy; Procedure: ozone therapy

pure PLD

ACTIVE COMPARATOR

Patients diagnosed as lumbar disc herniation undergoing percutaneous lumbar discectomy(PLD).

Procedure: percutaneous lumbar discectomy

Interventions

percutaneous lumbar discectomy PROCEDURE

process percutaneous lumbar discectomy

PLD combined with ozone; pure PLD

ozone therapy PROCEDURE

percutaneous intradiscal ozone injection

PLD combined with ozone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Hernia

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gao-jun Teng, Ph.D,MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology & Chair,Department of Radiology

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

CN (1)