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

Not Applicable

Recruiting

• Conditions: Radicular Pain; Disk Herniated Lumbar; Intradiscal Radiofrequency

• Registration Number: NCT05747807
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-25
• Last Update Posted: 2023-03-29
• Study Start: 2023-04-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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'.
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

Name	Time	Method
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
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.
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.
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.
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.
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

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand