Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

November 23, 2017 updated by: yan lu, Yan Lu

Comparison of the Efficacy Between Transforaminal Steroid Epidural Injection and Epidural Neuroplasty for the Treatment of Herniated Lumbar Disc：A Single Center, Controlled Clinical Trial

The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into two groups. One group will be treated with Transforaminal steroid injection, the other with epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six months post-treatment will be analysed statistically.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

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
    • Shaanxi
      • Xian, Shaanxi, China, 710132
        • Fourth Military Medical University china

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of herniated lumbar disc
  • written informed consent obtained

Exclusion Criteria:

  • Lumbar instability
  • Piriformis syndrome
  • Diabetes mellitus with uncontrolled blood glucose
  • Severe osteoporosis
  • Impaired function of cauda equina
  • Severe sacral hiatus variation
  • Interspinous ligament inflammation
  • Myofascitis on lumbar and legs
  • The third lumbar transverse process syndrome

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural neuroplasty group
This group will be given epidural neuroplasty once enrolled.
Device: Mechanical epidural neuroplasty
Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.
Drug: Caudal epidural compound betamethasone injection
steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.
Drug: Epidural hyaluronidase injection
Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.
Active Comparator: Transforaminal steroid injection group
This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.
Drug: Transforaminal epidural compound betamethasone injection
Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessed by Visual Analogue Scale
Time Frame: before treatment
VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
before treatment
Pain Assessed by Visual Analogue Scale
Time Frame: at one-month post-treatment
VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
at one-month post-treatment
Pain Assessed by Visual Analogue Scale
Time Frame: at three-month post-treatment
VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
at three-month post-treatment
Pain Assessed by Visual Analogue Scale
Time Frame: at six-month post-treatment
VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
at six-month post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status Assessed by Oswestry Disability Index
Time Frame: before treatment
ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
before treatment
Functional Status Assessed by Oswestry Disability Index
Time Frame: at one-month post-treatment
ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
at one-month post-treatment
Functional Status Assessed by Oswestry Disability Index
Time Frame: at three-month post-treatment
ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
at three-month post-treatment
Functional Status Assessed by Oswestry Disability Index
Time Frame: at six-month post-treatment
ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
at six-month post-treatment

Collaborators and Investigators

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

Sponsor

Yan Lu

Investigators

  • Study Director: Yan Lu, MD,PhD, Fourth Military Medical University china

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

November 23, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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