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

Study Overview
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Brief Summary
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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.

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

Conditions
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Disk Herniated Lumbar, Radicular Pain, Intradiscal Radiofrequency

Intervention / Treatment
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* Device: Percutaneous intradiscal radiofrequency treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: One group pre-posttest design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous intradiscal radiofrequency<br>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<br>* using heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc<br>* Other names: Flextrode;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |