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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04062474

Enrollment

Registered

2019-08-20

Start date

2016-05-15

Completion date

2017-05-01

Last updated

2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

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.

Interventions

PROCEDUREEpidural Intervention with TNF-α inhibitor

Epidural administration with TNF-α inhibitor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026