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

Disk Herniated Lumbar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747807
• Other study ID #: 0120/66
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Chulalongkorn University
• Contact: Rarinthorn Choomsai Na Ayuthaya, MD
• Phone: +6622564295
• Email: R.choomsai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Disk Herniated Lumbar
• Intervertebral Disc Displacement
• Radicular Pain

Intervention

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

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	pre-treatment
Secondary	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	2 week post-treatment
Secondary	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	3 month post-treatment
Secondary	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.	pre-treatment
Secondary	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.	2 week post-treatment
Secondary	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.	3 month post-treatment