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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: Epidural Intervention with TNF-α inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Intervention with Steroids<br>Epidural Intervention with Steroids | Procedure: Epidural Intervention with TNF-α inhibitor<br>* Epidural administration with TNF-α inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |