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

Primary Purpose

Spinal Stenosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Epidural Intervention with TNF-α inhibitor

About this trial

This is an interventional treatment trial for Spinal Stenosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epidural Intervention with Steroids

Arm Description

Epidural Intervention with Steroids

Outcomes

Primary Outcome Measures

visual analog scale

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

Oswestry Disability Index

Oswestry Disability Index is for movement function, Questionnaire examines

Secondary Outcome Measures

Full Information

NCT ID

NCT04062474

First Posted

August 19, 2019

Last Updated

August 19, 2019

Sponsor

Nanjing First Hospital, Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04062474

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 15, 2016 (Actual)

Primary Completion Date

December 15, 2016 (Actual)

Study Completion Date

May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epidural Intervention with Steroids

Arm Type

Experimental

Arm Description

Epidural Intervention with Steroids

Intervention Type

Procedure

Intervention Name(s)

Epidural Intervention with TNF-α inhibitor

Intervention Description

Epidural administration with TNF-α inhibitor

Primary Outcome Measure Information:

Title

visual analog scale

Description

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

Time Frame

6 months

Title

Oswestry Disability Index

Description

Oswestry Disability Index is for movement function, Questionnaire examines

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

31955619

Citation

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.

Results Reference

derived

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

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