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

Sponsor
Chulalongkorn University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05747807
Collaborator
(none)
18
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Percutaneous intradiscal radiofrequency treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
One group pre-posttest designOne group pre-posttest design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Device: Percutaneous intradiscal radiofrequency treatment
using heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc
Other Names:
  • Flextrode

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline radicular pain score at 2 weeks [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'.

    2. Change from baseline radicular pain score at 3 months [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 Outcome Measures

    1. Oswestry Disability Index (ODI) at baseline [pre-treatment]

      using Oswestry questionnaire version 1.0 - Thai version The ODI is comprised of 10 questions that ask patients about their ability to manage everyday life, and covers intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question contains 6 statements that correlate to a score of 0 through 5, where the patient is to choose the statement that best matches their ability. To obtain the index, the scores of all questions are summed and then multiplied by two. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.

    2. Oswestry Disability Index (ODI) at 2 weeks [2 week post-treatment]

      using Oswestry questionnaire version 1.0 - Thai version The ODI is comprised of 10 questions that ask patients about their ability to manage everyday life, and covers intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question contains 6 statements that correlate to a score of 0 through 5, where the patient is to choose the statement that best matches their ability. To obtain the index, the scores of all questions are summed and then multiplied by two. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. using Oswestry questionnaire version 1.0 - Thai version

    3. Oswestry Disability Index (ODI) at 3 months [3 month post-treatment]

      using Oswestry questionnaire version 1.0 - Thai version The ODI is comprised of 10 questions that ask patients about their ability to manage everyday life, and covers intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question contains 6 statements that correlate to a score of 0 through 5, where the patient is to choose the statement that best matches their ability. To obtain the index, the scores of all questions are summed and then multiplied by two. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. using Oswestry questionnaire version 1.0 - Thai version

    4. WHOQOL-Brief total score at baseline [pre-treatment]

      using WHOQOL-Brief-Thai questionnaire The WHO Quality of Life-BREF (WHOQOL-BREF) is a 26-item questionnaire that measures an individual's quality of life. The final score ranges from 0-100. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health.

    5. WHOQOL-Brief total score at 2 weeks [2 week post-treatment]

      using WHOQOL-Brief-Thai questionnaire The WHO Quality of Life-BREF (WHOQOL-BREF) is a 26-item questionnaire that measures an individual's quality of life. The final score ranges from 0-100. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health.

    6. WHOQOL-Brief total score at 3 months [3 month post-treatment]

      using WHOQOL-Brief-Thai questionnaire The WHO Quality of Life-BREF (WHOQOL-BREF) is a 26-item questionnaire that measures an individual's quality of life. The final score ranges from 0-100. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rarinthorn Choomsai Na Ayuthaya, MD, Principal Investigator, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT05747807
    Other Study ID Numbers:
    • 0120/66
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Intervertebral Disc Displacement

    Study Results

    No Results Posted as of Feb 28, 2023