An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia

An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia

An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia

This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device for the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that receives the sham device. Subjects will be monitored for subjective criteria of pain and quality of life, as well as objective measurement of analgesic usage.

This study is a double blinded randomized control trial of a Surface acoustic wave patch device for the treatment of Trigeminal Neuralgia. All subjects will be enrolled for a 14 day lead up period, where baseline measures of pain, quality of life and analgesic use will be recorded. During the first month of the study subjects will be randomized into a sham or active device group. Both groups will be assessed every two weeks for pain, quality of life and analgesic use. After 4 weeks, those subjects in the sham group will be crossed over into the active group. Both groups will continue to be assessed biweekly through months 2 and 3. After 3 months of treatment a final assessment will be conducted and the results evaluated.

After the enrollment and lead in period, subjects will be given a sham device to sleep with every night for a month. They will be asked to fill out their pain and analgesic use logs, and undergo the bi weekly assessments. After a month they will be crossed over to an active "Painshield SAW patch device" and will continue to complete their pain and analgesic use logs as well as undergo biweekly assessments for months two and 3.

After the enrollent and lead in period, subjects will be given an active PainSHield SAW Patch device to sleep with every night. They will be asked to fill out their pain and analgesic use logs, and undergo bi weekly assessments. They will continue to use the device while completing their logs and undergoing assessments for 3 months.

The PainShield is a self contained Surface Acoustic Wave device, where the waves are delivered locally through a trasnducer embedded into a patch that sits on the affected area.

Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Diagnosed with trigeminal neuralgia refractory to medical treatment (modified BNI V). Exclusion Criteria: Male or female, under the age of 18. Active illicit drug use Pregnancy. Psychiatric illness which may prevent the patient from participation in the study. Anesthesia dolorosa with pain greater than or equal to 3/10 Dental implants. Other known pathology of the trigeminal nerve including iatrogenic anesthesia dolorosa. Cancer and bone metastases.