NCT04062474

Brief Summary

This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

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 15, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

August 19, 2019

Last Update Submit

August 19, 2019

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (2)

  • visual analog scale

    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.

    6 months

  • Oswestry Disability Index

    Oswestry Disability Index is for movement function, Questionnaire examines

    6 months

Study Arms (1)

Epidural Intervention with Steroids

EXPERIMENTAL

Epidural Intervention with Steroids

Procedure: Epidural Intervention with TNF-α inhibitor

Interventions

Epidural Intervention with TNF-α inhibitorPROCEDURE

Epidural administration with TNF-α inhibitor

Epidural Intervention with Steroids

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of spinal stenosis with radicular pain at least 5 scores of VAS(ranging from 0 to 10).
  • Failed to improve symptom significantly through conservative treatment, including physiotherapy, chiropractic therapy, exercise, medication and bed rest.

You may not qualify if:

  • lumbar surgery history,
  • spinal stenosis without radicular pain,
  • uncontrollable or unstable use of opioids,
  • uncontrolled mental illness,
  • pregnant or lactating women,
  • patients with a history of adverse reactions or possible adverse reactions to local anesthetics, etanercept or Steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wei P, Xu Y, Yao Q, Wang L. Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-alpha inhibitor in treatment of lumbar stenosis. Br J Neurosurg. 2020 Apr;34(2):168-171. doi: 10.1080/02688697.2020.1713990. Epub 2020 Jan 20.

    PMID: 31955619DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 20, 2019

Study Start

May 15, 2016

Primary Completion

December 15, 2016

Study Completion

May 1, 2017

Last Updated

August 20, 2019

Record last verified: 2019-05