Disk Herniated LumbarNCT05747807
Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
A study testing Percutaneous intradiscal radiofrequency treatment in people with Disk Herniated Lumbar and Radicular Pain, run by Chulalongkorn University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Disk Herniated Lumbar, Radicular Pain, Intradiscal Radiofrequency
- What is being tested?
- Percutaneous intradiscal radiofrequency treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rarinthorn Choomsai Na Ayuthaya, MD, 022564295, R.choomsai@gmail.com
About this study
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.
- Being tested
- Percutaneous intradiscal radiofrequency treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous intradiscal radiofrequency treatmentDevice
Also called Flextrode
using heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous intradiscal radiofrequency | Experimental | 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 Receives: Device: Percutaneous intradiscal radiofrequency treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: pre-treatment and 3 months post-treatment
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disk Herniated LumbarStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group pre-posttest design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rarinthorn Choomsai Na Ayuthaya, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747807
- Sponsor's protocol ID
- 0120/66
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05747807
- Acronym / sponsor ID
- 0120/66
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group pre-posttest design
| Arm | Type | Receives |
|---|---|---|
| Percutaneous intradiscal radiofrequency | Experimental | Device: Percutaneous intradiscal radiofrequency treatmentStandard 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- Patient refusal
- Discitis
- Previous lumbar spine surgery
- Progressive neurological deficit and/or cauda equina syndrome
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous intradiscal radiofrequency treatmentAlso: Flextrodeusing heat created by radiofrequency electrode to destroy the nociceptive pain fibres and enhance the structural integrity of the disc | Device | Percutaneous intradiscal radiofrequency |
Primary outcome
Change from baseline radicular pain score at 2 weeks
Time frame: 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
Time frame: 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'.
6 secondary outcomes
Oswestry Disability Index (ODI) at baseline
Time frame: pre-treatment
Oswestry Disability Index (ODI) at 2 weeks
Time frame: 2 week post-treatment
Oswestry Disability Index (ODI) at 3 months
Time frame: 3 month post-treatment
WHOQOL-Brief total score at baseline
Time frame: pre-treatment
WHOQOL-Brief total score at 2 weeks
Time frame: 2 week post-treatment
WHOQOL-Brief total score at 3 months
Time frame: 3 month post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous intradiscal radiofrequency treatment in people with Disk Herniated Lumbar and Radicular Pain, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rarinthorn Choomsai Na Ayuthaya, MD (+6622564295, R.choomsai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline radicular pain score at 2 weeks (time frame: pre-treatment and 2 week post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.