Back to resultsPercutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
Primary Purpose
Disk Herniated Lumbar, Radicular Pain, Intradiscal Radiofrequency
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Percutaneous intradiscal radiofrequency treatment
Sponsored by
About this trial
This is an interventional treatment trial for Disk Herniated Lumbar
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 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
Sites / Locations
- King Chulalongkorn Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous intradiscal radiofrequency
Arm Description
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
Outcomes
Primary Outcome Measures
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'.
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'.
Secondary Outcome Measures
Oswestry Disability Index (ODI) at baseline
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.
Oswestry Disability Index (ODI) at 2 weeks
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
Oswestry Disability Index (ODI) at 3 months
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
WHOQOL-Brief total score at baseline
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.
WHOQOL-Brief total score at 2 weeks
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.
WHOQOL-Brief total score at 3 months
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.
Full Information
NCT ID
NCT05747807
First Posted
February 8, 2023
Last Updated
March 25, 2023
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT05747807
Brief Title
Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
Official Title
Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disk Herniated Lumbar, Radicular Pain, Intradiscal Radiofrequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group pre-posttest design
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous intradiscal radiofrequency
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Percutaneous intradiscal radiofrequency treatment
Other Intervention Name(s)
Flextrode
Intervention Description
using heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc
Primary Outcome Measure Information:
Title
Change from baseline radicular pain score at 2 weeks
Description
Radicular pain severity using numerical rating scale (0-10) Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
Time Frame
pre-treatment and 2 week post-treatment
Title
Change from baseline radicular pain score at 3 months
Description
Radicular pain severity using numerical rating scale (0-10) Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
Time Frame
pre-treatment and 3 months post-treatment
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI) at baseline
Description
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.
Time Frame
pre-treatment
Title
Oswestry Disability Index (ODI) at 2 weeks
Description
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
Time Frame
2 week post-treatment
Title
Oswestry Disability Index (ODI) at 3 months
Description
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
Time Frame
3 month post-treatment
Title
WHOQOL-Brief total score at baseline
Description
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.
Time Frame
pre-treatment
Title
WHOQOL-Brief total score at 2 weeks
Description
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.
Time Frame
2 week post-treatment
Title
WHOQOL-Brief total score at 3 months
Description
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.
Time Frame
3 month post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rarinthorn Choomsai Na Ayuthaya, MD
Phone
+6622564295
Email
R.choomsai@gmail.com
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rarinthorn Choomsai Na Ayuthaya, MD
Phone
022564295
Email
R.choomsai@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
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