Surface Acoustic Wave Ultrasound in Trigeminal Neuralgia Pain
The "Suicide Disease", Trigeminal Neuralgia (TN) is arguably caused by one of the most discrete and eloquently reversible central nervous system lesions known to the field of neurology.
Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects with refractory TN showing a remarkable positive response rate to TN's treatment with Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU).
The primary objective of this study, therefore, is to determine whether this apparent efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could withstand the rigors of an n=1 crossover placebo control study.
Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for at least six months will be screened for participation in the study based on rigorous inclusion and exclusion criteria. It is judged rather unlikely that such subjects will experience spontaneous regression of their disease in the course of this study.
Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU therapy for the next four weeks. Patients will be blinded to all treatments throughout the study. Patients will be instructed to use the device daily overnight, and remove it upon wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off, for a total of six- eight hours of intermittent treatment.
At the end of the second month of the study, patients will be offered a choice as to whether they wished to continue with the current (active) device or go back to the 1st (sham) device.
Patient's pain severity will be tracked every two weeks over the course of three months. Functional health and well being will be monitored at intake, post "Placebo" period, post "Active" period and at completion of the study.
|Trigeminal Neuralgia Tic Douloureux||Device: Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™)||Phase 4|
|Study Design:||Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Examining the Efficacy of Low Intensity Low Frequency Surface Acoustic Wave Ultrasound(LILF/SAWU) in Trigeminal Neuralgia Pain|
- Level of pain [ Time Frame: Change in level of pain from baseline to after two months of treatment ]Barrow Neurological Index score (BNI ) pain intensity scale will be used
- Pain intensity and quality of pain [ Time Frame: Change in intensity and quality of pain from baseline to after two months of treatment ]"SFMPQ" - Short form MCGILL Pain Questionnaire will be used.
- Functional Health and Wellbeing [ Time Frame: Change in functional health and wellbeing from baseline to after two months of treatment ]SF-36 Questionnaire will be used
|Study Start Date:||November 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: TN patients
Patients suffering from Trigeminal neuralgia
Device: Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™)
All subjects will be treated four weeks with a placebo PainShield™ while continuing with their current pharmaco- analgesic regimen. Aferterwards all subjects will be crossed over to active Painshield™ therapy for the next four weeks.
The Painshield™ device is a patch, which will be applied to their forehead for six-eight hours during night while sleeping.
Other Name: PainShield™
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01447108
|Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Principal Investigator:||Manuel Zwecker, MD||Sheba Medical Center|