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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2017-05-01

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.

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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.

Conditions

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Spinal Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural Intervention with Steroids

Group Type EXPERIMENTAL

Epidural Intervention with TNF-α inhibitor

Intervention Type PROCEDURE

Epidural administration with TNF-α inhibitor

Interventions

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Epidural Intervention with TNF-α inhibitor

Epidural administration with TNF-α inhibitor

Intervention Type PROCEDURE

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No