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

NCT05747807 | Unknown FDA Device

• 1 other identifier: 0120/66
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Disk Herniated Lumbar; Radicular Pain; Intradiscal Radiofrequency

Outcome Measures

Primary Outcomes (2)

• Change from baseline radicular pain score at 2 weeks

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

  pre-treatment and 2 week post-treatment

• Change from baseline radicular pain score at 3 months

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

  pre-treatment and 3 months post-treatment

Secondary Outcomes (6)

• Oswestry Disability Index (ODI) at baseline

  pre-treatment

• Oswestry Disability Index (ODI) at 2 weeks

  2 week post-treatment

• 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

Study Arms (1)

Percutaneous intradiscal radiofrequency

EXPERIMENTAL

Standard monitoring ,prone position, sterile prepped and draped No sedation, Fentanyl 0.5-2 mcg/kg IV as needed ATB prophylaxis: ceftriaxone 1 g IV Performed by interventional pain physician, under fluoroscopic guidance 2% lidocaine 5 ml LA using Flextrode introducer kit, Boston Scientific Corporation Using an extrapedicular approach ipsilateral to the prolapse, the Flextrode cannula is advanced to the posterior disc. The Flextrode electrode is inserted through the cannula. Sensory (50Hz) and motor (2Hz) stimulation, 3 Volts amplitude and 1msec pulse width. Confirm no sensory/motor response. Lateral, AP, and oblique x-ray views are used to confirm the active tips are fully within the disc Thermal RF: temp 80 ◦C, 4 min Ceftriaxone 75 mg intradiscal injection via the cannula

Device: Percutaneous intradiscal radiofrequency treatment

Interventions

Percutaneous intradiscal radiofrequency treatment DEVICE

using heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc

Also known as: Flextrode

Percutaneous intradiscal radiofrequency

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient refusal
• Discitis
• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

Central Study Contacts

Rarinthorn Choomsai Na Ayuthaya, MD

CONTACT

+6622564295; R.choomsai@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group pre-posttest design

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 28, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)