NCT03101033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 4, 2018

Completed
Last Updated

September 4, 2018

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

March 14, 2017

Results QC Date

April 9, 2017

Last Update Submit

November 23, 2017

Conditions

Herniated Lumbar Disc

Keywords

Herniated lumbar discEpidural neuroplastyEpidural injection

Outcome Measures

Primary Outcomes (4)

  • Pain Assessed by Visual Analogue Scale

    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

    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

    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

    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 Outcomes (4)

  • Functional Status Assessed by Oswestry Disability Index

    before treatment

  • Functional Status Assessed by Oswestry Disability Index

    at one-month post-treatment

  • Functional Status Assessed by Oswestry Disability Index

    at three-month post-treatment

  • Functional Status Assessed by Oswestry Disability Index

    at six-month post-treatment

Study Arms (2)

Epidural neuroplasty group

EXPERIMENTAL

This group will be given epidural neuroplasty once enrolled.

Device: Mechanical epidural neuroplastyDrug: Caudal epidural compound betamethasone injectionDrug: Epidural hyaluronidase injection

Transforaminal steroid injection group

ACTIVE COMPARATOR

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

Interventions

Mechanical epidural neuroplastyDEVICE

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.

Epidural neuroplasty group
Transforaminal epidural compound betamethasone injectionDRUG

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.

Transforaminal steroid injection group
Caudal epidural compound betamethasone injectionDRUG

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 neuroplasty group
Epidural hyaluronidase injectionDRUG

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.

Epidural neuroplasty group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Military Medical University china

Xi'an, Shaanxi, 710132, China

Location

Related Publications (7)

  • Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch Phys Med Rehabil. 1998 Nov;79(11):1362-6. doi: 10.1016/s0003-9993(98)90228-3.

    PMID: 9821894BACKGROUND

  • Veihelmann A, Devens C, Trouillier H, Birkenmaier C, Gerdesmeyer L, Refior HJ. Epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica: a prospective randomized blinded clinical trial. J Orthop Sci. 2006 Jul;11(4):365-9. doi: 10.1007/s00776-006-1032-y.

    PMID: 16897200BACKGROUND

  • Manchikanti L, Pampati V, Fellows B, Rivera J, Beyer CD, Damron KS. Role of one day epidural adhesiolysis in management of chronic low back pain: a randomized clinical trial. Pain Physician. 2001 Apr;4(2):153-66.

    PMID: 16902688BACKGROUND

  • Manchikanti L, Rivera JJ, Pampati V, Damron KS, McManus CD, Brandon DE, Wilson SR. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized, double-blind trial. Pain Physician. 2004 Apr;7(2):177-86.

    PMID: 16868590BACKGROUND

  • Vad VB, Bhat AL, Lutz GE, Cammisa F. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study. Spine (Phila Pa 1976). 2002 Jan 1;27(1):11-6. doi: 10.1097/00007632-200201010-00005.

    PMID: 11805628BACKGROUND

  • McCarron RF, Wimpee MW, Hudkins PG, Laros GS. The inflammatory effect of nucleus pulposus. A possible element in the pathogenesis of low-back pain. Spine (Phila Pa 1976). 1987 Oct;12(8):760-4. doi: 10.1097/00007632-198710000-00009.

    PMID: 2961088BACKGROUND

  • Kim HJ, Rim BC, Lim JW, Park NK, Kang TW, Sohn MK, Beom J, Kang S. Efficacy of epidural neuroplasty versus transforaminal epidural steroid injection for the radiating pain caused by a herniated lumbar disc. Ann Rehabil Med. 2013 Dec;37(6):824-31. doi: 10.5535/arm.2013.37.6.824. Epub 2013 Dec 23.

    PMID: 24466517BACKGROUND

Results Point of Contact

Title
Dr yan lu
Organization
Xijing Hospital, the Fourth Military Medical University
yanlu001@fmmu.edu.cn
029-84775337

Study Officials

  • Yan Lu, MD,PhD

    Fourth Military Medical University China

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the pain clinic of Xijing Hospital

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 4, 2017

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

September 4, 2018

Results First Posted

September 4, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)