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

Primary Purpose

Lumbar Radiculopathy, Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pulsed Radiofrequency
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lumbar Radiculopathy focused on measuring fMRI, PRF

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Clinic Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRF-fMRI

Arm Description

Outcomes

Primary Outcome Measures

Central working mechanism
fMRI-BOLD

Secondary Outcome Measures

Central working mechanism
Numeric Rating Scale (NRS)
Central working mechanism
Douleur Neuropathique Questionnaire 4 (DN 4)

Full Information

First Posted
May 22, 2017
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03185442
Brief Title
Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.
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).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy, Chronic Disease
Keywords
fMRI, PRF

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRF-fMRI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Pulsed Radiofrequency
Intervention Description
Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses
Primary Outcome Measure Information:
Title
Central working mechanism
Description
fMRI-BOLD
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Central working mechanism
Description
Numeric Rating Scale (NRS)
Time Frame
3 times in 6 weeks
Title
Central working mechanism
Description
Douleur Neuropathique Questionnaire 4 (DN 4)
Time Frame
2 times in 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veerle Van Mossevelde, Data Nurse
Phone
+3224763134
Email
veerle.vanmossevelde@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk De Clippeleir, Data Nurse
Phone
+324763580
Email
dirk.declippeleir@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier De Coster, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrice Forget, PhD MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, PhDMD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
Pain Clinic Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veerle Van Mossevelde, Study Nurse
Phone
+3224763134
Email
veerle.vanmossevelde@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Dirk De Clippeleir, Study Nurse
Phone
+3224763580
Email
dirk.declippeleir@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Olivier Decoster, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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