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

September 26, 2016 updated by: Rosenblum, Jonathan I., DPM
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 90 days
The Patients level of pain will be assessed by Visual Analog Scale daily
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 90 days
The patients satisfaction and quality of life will be measured by questionnaires including the SF-36
90 days
Rescue Drug Use
Time Frame: 90 days
The patients use of rescue medication will be recorded during the duration of the study
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosenblum, Jonathan I., DPM

Collaborators

Nanovibronix

Investigators

  • Study Director: William Stern, Sponsor Representative

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

August 1, 2017

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (ESTIMATE)

June 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USTN1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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