Recruiting

Surface Acoustic Wave

Sponsor:

Rosenblum, Jonathan I., DPM

Code:

NCT02801630

Conditions

Trigeminal Neuralgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PainShield SAW Patch Device

Study Details

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.

Conditions

Trigeminal Neuralgia

Study ID

NCT02801630

Start date

Sep, 2016

Status verified date

Sep, 2016

Completion date

Aug, 2017

Anticipated

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Crossover

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.

active comparator: Active Device

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.

Interventions

PainShield 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.

Primary outcome measure

  • Pain [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Jonathan Rosenblum

+1-720-744-3222diabfootman@gmail.com

Locations

NanoVibronix

Recruiting

Elmsford, New York, United States, 07055

Contacts

Jonathan Rosenblum

720-744-3222diabfootman@gmail.com

william stern

9143765200william.stern@yahoo.com

More Information

Sponsor

Rosenblum, Jonathan I., DPM

Last update posted

Sep 27, 2016

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rosenblum, Jonathan I., DPM on 2016-09-27.