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

Not Applicable

• Conditions: Lumbar Radiculopathy; Chronic Disease
• Interventions: Device: Pulsed Radiofrequency

• Registration Number: NCT03185442
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

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 Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2018-07-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-07-15
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRF-fMRI	Pulsed Radiofrequency	-

Primary Outcome Measures

Name	Time	Method
Central working mechanism	6 weeks	fMRI-BOLD

Secondary Outcome Measures

Name	Time	Method
Central working mechanism	2 times in 6 weeks	Douleur Neuropathique Questionnaire 4 (DN 4)

Trial Locations

Locations (1)

Pain Clinic Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams Brabant, Belgium