Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor

August 19, 2019 updated by: Nanjing First Hospital, Nanjing Medical University

Treatment of Pain in Patients With Lumbar Spinal Stenosis By Epidural Intervention of Spinal Nerves With Local Anesthetic, Steroids and Tumor Necrosis Factor-Alpha Inhibitor Respectively：a Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated by VAS and ODI, and received 6 months' follow-up.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

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

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Epidural Intervention with Steroids
Procedure: Epidural Intervention with TNF-α inhibitor
Epidural administration with TNF-α inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 6 months
Oswestry Disability Index is for movement function, Questionnaire examines
6 months
visual analog scale
Time Frame: 6 months
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
6 months

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

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 (ACTUAL)

May 15, 2016

Primary Completion (ACTUAL)

December 15, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (ACTUAL)

August 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20151014-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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