Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.

Chronic Disease Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03185442
• Other study ID #: fMRI-PRF-DRG v 1.0
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, Data Nurse
• Phone: +3224763134
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 study 20. Total amount of subjects 25.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 y

• Radicular pain in lumbar region more than 6 weeks, neuropathic

Exclusion Criteria:

• Coagulopathy

• Implanted PM or SCS device

• Pregnancy

• Unwilling to undergo MRI

• Psychiatric disorders

Related Conditions & MeSH terms

• Chronic Disease
• Lumbar Radiculopathy
• Radiculopathy

Intervention

Device:
• Pulsed Radiofrequency
Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses

Locations

Country	Name	City	State
Belgium	Pain Clinic Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central working mechanism	fMRI-BOLD	6 weeks
Secondary	Central working mechanism	Numeric Rating Scale (NRS)	3 times in 6 weeks
Secondary	Central working mechanism	Douleur Neuropathique Questionnaire 4 (DN 4)	2 times in 6 weeks