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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062474
• Other study ID #: KY20151014-01
• Status: Completed
• Phase: N/A
• Start date: May 15, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 1, 2017
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Necrosis
• Spinal Stenosis

Intervention

Procedure:
• Epidural Intervention with TNF-a inhibitor
Epidural administration with TNF-a inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.	6 months
Primary	Oswestry Disability Index	Oswestry Disability Index is for movement function, Questionnaire examines	6 months