Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor
Primary Purpose
Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epidural Intervention with TNF-α inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epidural Intervention with Steroids
Arm Description
Epidural Intervention with Steroids
Outcomes
Primary Outcome Measures
visual analog scale
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Oswestry Disability Index
Oswestry Disability Index is for movement function, Questionnaire examines
Secondary Outcome Measures
Full Information
NCT ID
NCT04062474
First Posted
August 19, 2019
Last Updated
August 19, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04062474
Brief Title
Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2016 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural Intervention with Steroids
Arm Type
Experimental
Arm Description
Epidural Intervention with Steroids
Intervention Type
Procedure
Intervention Name(s)
Epidural Intervention with TNF-α inhibitor
Intervention Description
Epidural administration with TNF-α inhibitor
Primary Outcome Measure Information:
Title
visual analog scale
Description
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Time Frame
6 months
Title
Oswestry Disability Index
Description
Oswestry Disability Index is for movement function, Questionnaire examines
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
31955619
Citation
Wei P, Xu Y, Yao Q, Wang L. Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-alpha inhibitor in treatment of lumbar stenosis. Br J Neurosurg. 2020 Apr;34(2):168-171. doi: 10.1080/02688697.2020.1713990. Epub 2020 Jan 20.
Results Reference
derived
Learn more about this trial
Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor
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