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Clinical Trials/NCT05747807
NCT05747807
Recruiting
Not Applicable

Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation

Chulalongkorn University1 site in 1 country18 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disk Herniated Lumbar
Sponsor
Chulalongkorn University
Enrollment
18
Locations
1
Primary Endpoint
Change from baseline radicular pain score at 2 weeks
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The goal of this clinical trial is to demonstrate the efficacy of percutaneous intradiscal radiofrequency as a treatment for radicular pain from lumbar disc herniation.

The main question it aims to answer is:

• Can percutaneous intradiscal radiofrequency lower the severity of radicular pain from lumbar disc herniation Participants will be treated with percutaneous intradiscal radiofrequency and evaluated for radicular pain severity before and 3 months after the procedure.

There is no comparison group.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
March 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rarinthorn Choomsai Na Ayuthaya, MD

Principal Investigator

Chulalongkorn University

Eligibility Criteria

Inclusion Criteria

  • 18-85 year-old patients with radicular pain from lumbar disc herniation for ≥ 3 months
  • Lumbar disc herniation ≤ 2 locations evidenced by MRI, with ≥ 50% remaining disc height, without disc sequestration
  • Previously treated with epidural steroid injection (ESI) and achieved ≥ 50 % pain relief from local anesthetic effect, confirming radicular pain from lumbar disc herniation, but did not respond to ESI (\< 50 % Pain relief or pain relief \< 3 months)

Exclusion Criteria

  • Patient refusal
  • Previous lumbar spine surgery
  • Progressive neurological deficit and/or cauda equina syndrome
  • Coagulopathy
  • Allergic to any medication in study protocols
  • Unable to rate the pain
  • Pain in any area worse than the radicular pain

Outcomes

Primary Outcomes

Change from baseline radicular pain score at 2 weeks

Time Frame: pre-treatment and 2 week post-treatment

Radicular pain severity using numerical rating scale (0-10) Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.

Change from baseline radicular pain score at 3 months

Time Frame: pre-treatment and 3 months post-treatment

Radicular pain severity using numerical rating scale (0-10) Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.

Secondary Outcomes

  • Oswestry Disability Index (ODI) at 3 months(3 month post-treatment)
  • WHOQOL-Brief total score at baseline(pre-treatment)
  • WHOQOL-Brief total score at 2 weeks(2 week post-treatment)
  • WHOQOL-Brief total score at 3 months(3 month post-treatment)
  • Oswestry Disability Index (ODI) at baseline(pre-treatment)
  • Oswestry Disability Index (ODI) at 2 weeks(2 week post-treatment)

Study Sites (1)

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