Lumbar RadiculopathyNCT04876469
Radiocontrast Media in the Pulsed Radiofrequency Treatment
A study testing Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion in people with Lumbar Radiculopathy and Pain, Intractable, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast media. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy, Pain, Intractable
- What is being tested?
- Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jul 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age.
- Lumbar radicular pain
- Lack of response to conservative methods
- L5 nerve root compression due to disc herniation
Who cannot join
- Patients younger than 18 and older than 65
- Non-radicular low back pain
- L5 nerve root compression due to reasons other than disc herniation
- Those having spondylolisthesis, or transitional vertebra
- Having an active infection
- Pregnancy
- Bleeding diathesis
- Renal Insufficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanliurfa Education and Research Hospital
Sanliurfa
Serdar Kokar, +905416415143, srdrkkr@hotmail.com
About this study
Official title: The Role of Radiocontrast Media in Pulsed Radiofrequency Treatment of Lumbar Dorsal Root Ganglion
Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast media. We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.
Read the detailed description
Although there are many reasons that can lead to low back pain, radicular pain, which is mostly secondary to lumbar disc hernia, is one of the most common pathologies. Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods and epidural injection treatments.
The electrical field created by the application of pulsed radiofrequency (PRF) changes the cellular activity in DRG neurons. By polarizing cell membranes, reduces nociceptive transmission and contributes to analgesia. In lumbar dorsal root ganglion PRF applications, when the targeted point is reached, the position is confirmed by giving motor and sensory stimuli, and the PRF application is initiated in the follow-up. However, it is a problem that the DRG is not always in the same location, and therefore, time is often lost or even not found while searching with stimulation. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast material.
We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.
- Conditions
- Lumbar Radiculopathy, Pain, Intractable
- Being tested
- Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion
- Keywords
- pulsed radiofrequency treatment, lumbar radicular pain, fluoroscopy
- Medical subject headings
- Radiculopathy, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency treatment of the lumbar dorsal root ganglionProcedure or surgery
Using radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion
| Study group | Role | What they receive |
|---|---|---|
| Radiocontrast media group | Active comparator | Pulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level) in both groups.
In patients in the Radiocontrast media group, contrast material will be given before the application, and primarily the localization of the DRG will be determined. After this stage, the needle will be directed towards the detected localization. Finally, the localization of the dorsal root ganglion will be confirmed by sensory and motor stimuli. Receives: Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion |
| Non-radiocontrast media group | Active comparator | Pulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level).
In patients in the Non-radiocontrast media group, the localization of the dorsal root ganglion will be determined just by sensory and motor stimuli. Receives: Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
The time from cutaneous anesthesia to confirmation of the dorsal root ganglion position by motor and sensory stimulation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Mar 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serdar Kokar, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876469
- Sponsor's protocol ID
- 01.02.2021-E.7779
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moon HS, Kim YD, Song BH, Cha YD, Song JH, Lee MH. Position of dorsal root ganglia in the lumbosacral region in patients with radiculopathy. Korean J Anesthesiol. 2010 Dec;59(6):398-402. doi: 10.4097/kjae.2010.59.6.398. Epub 2010 Dec 31.
PubMed 21253377Liem L, van Dongen E, Huygen FJ, Staats P, Kramer J. The Dorsal Root Ganglion as a Therapeutic Target for Chronic Pain. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):511-9. doi: 10.1097/AAP.0000000000000408.
PubMed 27224659Vanneste T, Van Lantschoot A, Van Boxem K, Van Zundert J. Pulsed radiofrequency in chronic pain. Curr Opin Anaesthesiol. 2017 Oct;30(5):577-582. doi: 10.1097/ACO.0000000000000502.
PubMed 28700369Malik K, Benzon HT. Radiofrequency applications to dorsal root ganglia: a literature review. Anesthesiology. 2008 Sep;109(3):527-42. doi: 10.1097/ALN.0b013e318182c86e.
PubMed 18719452
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Radiocontrast Media in Pulsed Radiofrequency Treatment of Lumbar Dorsal Root Ganglion
- ClinicalTrials.gov ID
- NCT04876469
- Acronym / sponsor ID
- 01.02.2021-E.7779
- Conditions
- Lumbar Radiculopathy, Pain, Intractable
- Keywords
- pulsed radiofrequency treatment, lumbar radicular pain, fluoroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 6 May 2021 (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.
Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast media. We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.
Detailed description
Although there are many reasons that can lead to low back pain, radicular pain, which is mostly secondary to lumbar disc hernia, is one of the most common pathologies. Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods and epidural injection treatments.
The electrical field created by the application of pulsed radiofrequency (PRF) changes the cellular activity in DRG neurons. By polarizing cell membranes, reduces nociceptive transmission and contributes to analgesia. In lumbar dorsal root ganglion PRF applications, when the targeted point is reached, the position is confirmed by giving motor and sensory stimuli, and the PRF application is initiated in the follow-up. However, it is a problem that the DRG is not always in the same location, and therefore, time is often lost or even not found while searching with stimulation. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast material.
We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiocontrast media group | Active comparator | Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglionPulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level) in both groups. In patients in the Radiocontrast media group, contrast material will be given before the application, and primarily the localization of the DRG will be determined. After this stage, the needle will be directed towards the detected localization. Finally, the localization of the dorsal root ganglion will be confirmed by sensory and motor stimuli. |
| Non-radiocontrast media group | Active comparator | Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglionPulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level). In patients in the Non-radiocontrast media group, the localization of the dorsal root ganglion will be determined just by sensory and motor stimuli. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age.
- Lumbar radicular pain
- Lack of response to conservative methods
- L5 nerve root compression due to disc herniation
Key exclusion criteria (8 listed)
- Patients younger than 18 and older than 65
- Non-radicular low back pain
- L5 nerve root compression due to reasons other than disc herniation
- Those having spondylolisthesis, or transitional vertebra
- Having an active infection
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 |
|---|---|---|
| Pulsed Radiofrequency treatment of the lumbar dorsal root ganglionUsing radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion | Procedure or surgery | Non-radiocontrast media group, Radiocontrast media group |
Primary outcome
Procedure time
Time frame: 3 months
The time from cutaneous anesthesia to confirmation of the dorsal root ganglion position by motor and sensory stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 21253377Moon HS, Kim YD, Song BH, Cha YD, Song JH, Lee MH. Position of dorsal root ganglia in the lumbosacral region in patients with radiculopathy. Korean J Anesthesiol. 2010 Dec;59(6):398-402. doi: 10.4097/kjae.2010.59.6.398. Epub 2010 Dec 31.
- Background: PubMed 27224659Liem L, van Dongen E, Huygen FJ, Staats P, Kramer J. The Dorsal Root Ganglion as a Therapeutic Target for Chronic Pain. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):511-9. doi: 10.1097/AAP.0000000000000408.
- Background: PubMed 28700369Vanneste T, Van Lantschoot A, Van Boxem K, Van Zundert J. Pulsed radiofrequency in chronic pain. Curr Opin Anaesthesiol. 2017 Oct;30(5):577-582. doi: 10.1097/ACO.0000000000000502.
- Background: PubMed 18719452Malik K, Benzon HT. Radiofrequency applications to dorsal root ganglia: a literature review. Anesthesiology. 2008 Sep;109(3):527-42. doi: 10.1097/ALN.0b013e318182c86e.
- 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.
Sanliurfa Education and Research Hospital
Sanliurfa, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion in people with Lumbar Radiculopathy and Pain, Intractable, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 6 May 2021. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876469, which also lists 4 linked publications.
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 6 May 2021.