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

Not Applicable

Completed

• Conditions: Spinal Stenosis
• Interventions: Procedure: Epidural Intervention with TNF-α inhibitor

• Registration Number: NCT04062474
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2016-05-15
• Primary Completion: 2016-12-15
• Study Completion: 2017-05-01
• Status Verified: 2019-05
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-20
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural Intervention with Steroids	Epidural Intervention with TNF-α inhibitor	Epidural Intervention with Steroids

Primary Outcome Measures

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