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Completed

NCT Number: NCT03101033

Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

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.

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Key information

Conditions

Herniated Lumbar Disc

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fourth Military Medical University china

Xi'an, Shaanxi, 710132, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical epidural neuroplasty

Device

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.

Transforaminal epidural compound betamethasone injection

Drug

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.

Caudal epidural compound betamethasone injection

Drug

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.

Epidural hyaluronidase injection

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Yan Lu

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2017
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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