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Trial record 6 of 561 for:    Cachectin OR Tumor Necrosis Factor-alpha

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

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ClinicalTrials.gov Identifier: NCT04062474
Recruitment Status : Completed
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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 : December 15, 2016
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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




Primary Outcome Measures :
  1. visual analog scale [ Time Frame: 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 [ Time Frame: 6 months ]
    Oswestry Disability Index is for movement function, Questionnaire examines



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04062474     History of Changes
Other Study ID Numbers: KY20151014-01
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Necrosis
Pathological Conditions, Anatomical
Pathologic Processes
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases