Lumbar RadiculopathyNCT03185442
Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.
A study testing Pulsed Radiofrequency in people with Lumbar Radiculopathy and Chronic Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Radiculopathy, Chronic Disease
- What is being tested?
- Pulsed Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jul 2018to 31 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 y
- Radicular pain in lumbar region more than 6 weeks, neuropathic
Who cannot join
- Coagulopathy
- Implanted PM or SCS device
- Pregnancy
- Unwilling to undergo MRI
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Pain Clinic Universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090
Veerle Van Mossevelde, Study Nurse, +3224763134, veerle.vanmossevelde@uzbrussel.be
Dirk De Clippeleir, Study Nurse, +3224763580, dirk.declippeleir@uzbrussel.be
About this study
Official title: Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).
Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.
Read the detailed description
Detect and prove the central effects of PRF and show the objective working mechanism.
PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism.
The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.
- Conditions
- Lumbar Radiculopathy, Chronic Disease
- Being tested
- Pulsed Radiofrequency
- Keywords
- fMRI, PRF
- Medical subject headings
- Radiculopathy, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed RadiofrequencyDevice
Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses
| Study group | Role | What they receive |
|---|---|---|
| PRF-fMRI | Experimental | Not described Receives: Device: Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central working mechanism
fMRI-BOLD
Measured: 6 weeks
Secondary outcomes (2)
Central working mechanism
Numeric Rating Scale (NRS)
Measured: 3 times in 6 weeks
Central working mechanism
Douleur Neuropathique Questionnaire 4 (DN 4)
Measured: 2 times in 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start2 Jul 2018
- Primary completion15 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Olivier De Coster, MD, Principal investigator, Universitair Ziekenhuis BrusselPatrice Forget, PhD MD, Study director, Universitair Ziekenhuis BrusselJan Poelaert, PhDMD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185442
- Sponsor's protocol ID
- fMRI-PRF-DRG v 1.0
- Status last verified
- Apr 2019
- First submitted
- 22 May 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).
- ClinicalTrials.gov ID
- NCT03185442
- Acronym / sponsor ID
- fMRI-PRF-DRG v 1.0
- Conditions
- Lumbar Radiculopathy, Chronic Disease
- Keywords
- fMRI, PRF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Jun 2017 (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.
Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.
Detailed description
Detect and prove the central effects of PRF and show the objective working mechanism.
PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism.
The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRF-fMRI | Experimental | Device: Pulsed Radiofrequency |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-75 y
- Radicular pain in lumbar region more than 6 weeks, neuropathic
Key exclusion criteria (5 listed)
- Coagulopathy
- Implanted PM or SCS device
- Pregnancy
- Unwilling to undergo MRI
- Psychiatric disorders
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 RadiofrequencyPulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses | Device | PRF-fMRI |
Primary outcome
Central working mechanism
Time frame: 6 weeks
fMRI-BOLD
2 secondary outcomes
Central working mechanism
Time frame: 3 times in 6 weeks
Central working mechanism
Time frame: 2 times in 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- 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.
Olivier De Coster, MD principal investigator
Universitair Ziekenhuis Brussel
Patrice Forget, PhD MD study director
Universitair Ziekenhuis Brussel
Jan Poelaert, PhDMD study chair
Universitair Ziekenhuis Brussel
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 in people with Lumbar Radiculopathy and Chronic Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 2 inclusion and 5 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 17 Apr 2019. 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 Belgium. 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 Veerle Van Mossevelde, Data Nurse (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central working mechanism (time frame: 6 weeks). 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 17 Apr 2019.