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

Nanjing Medical University

Status

Completed

Conditions

Spinal Stenosis

Treatments

Procedure: Epidural Intervention with TNF-α inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT04062474

KY20151014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No 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.