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

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04062474
• Collaborator: (none)
• Enrollment: 90
• Arm: 1
• Actual Duration (Months): 11.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis	Procedure: Epidural Intervention with TNF-α inhibitor	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 15, 2016
• Actual Primary Completion Date: Dec 15, 2016
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural Intervention with Steroids Epidural Intervention with Steroids	Procedure: Epidural Intervention with TNF-α inhibitor; Epidural administration with TNF-α inhibitor

Outcome Measures

Primary Outcome Measures

1. visual analog scale [6 months]

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

2. Oswestry Disability Index [6 months]

   Oswestry Disability Index is for movement function, Questionnaire examines

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04062474
• Other Study ID Numbers: KY20151014-01
• First Posted: Aug 20, 2019
• Last Update Posted: Aug 20, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic; Necrosis

Study Results

No Results Posted as of Aug 20, 2019