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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRF-fMRI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Radiofrequency | Device | Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central working mechanism | fMRI-BOLD | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Central working mechanism | Numeric Rating Scale (NRS) | 3 times in 6 weeks |
| Central working mechanism | Douleur Neuropathique Questionnaire 4 (DN 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veerle Van Mossevelde, Data Nurse | Contact | +3224763134 | veerle.vanmossevelde@uzbrussel.be | |
| Dirk De Clippeleir, Data Nurse | Contact | +324763580 | dirk.declippeleir@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Olivier De Coster, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Patrice Forget, PhD MD | Universitair Ziekenhuis Brussel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Clinic Universitair Ziekenhuis Brussel | Recruiting | Jette | Vlaams Brabant | 1090 | Belgium |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
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| 2 times in 6 weeks |
| Jan Poelaert, PhDMD |
| Universitair Ziekenhuis Brussel |
| Study Chair |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |