Trigeminal Neuralgia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPainShield SAW Patch Device
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.
Sponsors
Rosenblum, Jonathan I., DPM
Nanovibronix
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 90 days | The Patients level of pain will be assessed by Visual Analog Scale daily |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 90 days | The patients satisfaction and quality of life will be measured by questionnaires including the SF-36 |
| Rescue Drug Use | 90 days | The patients use of rescue medication will be recorded during the duration of the study |
Countries
United States
Contacts
Primary ContactJonathan Rosenblum
Outcome results
None listed