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

NCT ID: NCT05747807

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous intradiscal radiofrequency

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

Group Type: EXPERIMENTAL

Percutaneous intradiscal radiofrequency treatment

Intervention Type: DEVICE

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

Interventions

Percutaneous intradiscal radiofrequency treatment

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

Intervention Type: DEVICE

Other Intervention Names

Flextrode

Eligibility Criteria

Inclusion Criteria

1. 18-85 year-old patients with radicular pain from lumbar disc herniation for ≥ 3 months

2. Lumbar disc herniation ≤ 2 locations evidenced by MRI, with ≥ 50% remaining disc height, without disc sequestration

3. 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Rarinthorn Choomsai Na Ayuthaya, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Rarinthorn Choomsai Na Ayuthaya, MD

Role: CONTACT

R.choomsai@gmail.com

+6622564295

Facility Contacts

Rarinthorn Choomsai Na Ayuthaya, MD

Role: primary

R.choomsai@gmail.com

022564295

Other Identifiers

0120/66

Identifier Type: -

Identifier Source: org_study_id