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

Nanjing First Hospital, Nanjing Medical University90 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Stenosis

Interventions

Epidural Intervention with TNF-α inhibitorPROCEDURE

Epidural administration with TNF-α inhibitor

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

visual analog scale

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

Time frame: 6 months

Oswestry Disability Index

Oswestry Disability Index is for movement function, Questionnaire examines

Time frame: 6 months

Data from ClinicalTrials.gov

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