Disk Herniated Lumbar, Intradiscal Radiofrequency, Radicular Pain
Conditions
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.
Interventions
DEVICEPercutaneous intradiscal radiofrequency treatment
using heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc
Sponsors
Chulalongkorn University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group pre-posttest design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Thailand
Contacts
Primary ContactRarinthorn Choomsai Na Ayuthaya, MD
Outcome results
None listed