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NCT Number: NCT04062474

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

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural Intervention with TNF-α inhibitor

Procedure

Epidural administration with TNF-α inhibitor

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 20, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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