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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02801630
Other study ID # USTN1
Secondary ID
Status Recruiting
Phase N/A
First received June 13, 2016
Last updated September 26, 2016
Start date September 2016
Est. completion date August 2017

Study information

Verified date September 2016
Source Rosenblum, Jonathan I., DPM
Contact Jonathan Rosenblum
Phone +1-720-744-3222
Email diabfootman@gmail.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States NanoVibronix Elmsford New York

Sponsors (2)

Lead Sponsor Collaborator
Rosenblum, Jonathan I., DPM Nanovibronix

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain The Patients level of pain will be assessed by Visual Analog Scale daily 90 days No
Secondary Quality of Life The patients satisfaction and quality of life will be measured by questionnaires including the SF-36 90 days No
Secondary Rescue Drug Use The patients use of rescue medication will be recorded during the duration of the study 90 days No
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