Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04936659 |
| Other study ID # |
1444471 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 13, 2017 |
| Est. completion date |
May 1, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
University of North Texas Health Science Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to assess the extent to which a non-invasive, palpatory
neuromodulatory protocol on the trigeminal nerve endings on the face can affect tenderness
felt on the posterior neck musculature, using the Isotouch pressure sensor system.
Specific Aim 1: Subjects will see a decrease in tenderness in the posterior neck musculature.
Specific Aim 2: Subjects will show a decrease in tenderness on the trigeminal tender points
found on the face.
Description:
Study Instrumentation: The Isotouch sensor device and software is a passive sensor device
that allows for real-time, constant visualization of pressure information. The system
electronics are remote (on the packet usually worn on the wrist) and the current supports a
Bluetooth data stream. The sensor has input power on the wrist and minimal microcurrent
output. The pressure range for the device ranges from 0-100 pounds per square inch (PSI),
although this study will only be using pressure of 0.5 to three pounds of pressure. The
sensors are made of both cloth and Polyimide material. This software will be directly used in
the neuromodulatory intervention as described below. The sensors will be used both for the
palpatory evaluation of trigeminal tender points on the face as well as the neuromodulation
portion of the protocol.
Subjects interested in the study will email the NeckPainResearch@unthsc.edu account to
express their interest in participating. The co-investigators will email the subject an
initial survey to answer questions about the inclusion and exclusion criteria. This survey
will primarily consist of questions related to the potential participant's medical history,
to best determine if they qualify for the study. If subjects qualify, they will be contacted
via telephone (by the principal or a co-investigator) to schedule a time to participate in
the study visit. Once a visit is scheduled, the participant will meet the investigators in a
private setting either at the UNTHSC campus or other community based designated area. After
the consenting process is completed, the inclusion and exclusion criteria will be
re-reviewed. If the subject qualifies, they will be consented and fill out a brief
questionnaire. Subjects will be verbally asked for demographic information including their
age, weight, height, gender, and have their neck circumference measured by the principal
investigator or a co-investigator.
After consenting, the subject will be taken to the operator (the principal or
co-investigator) who will be in clinical patient room with the IsoTouch software (see
diagram). The subject will lie supine on the exam table.
The operator will be wearing two IsoTouch finger sensors; one on each index finger. Non-latex
coverings will be used over the IsoTouch software pressure sensors to protect the
instrumentation from the natural oils of human skin, as well as the participant. The operator
will palpate 1 inch posteromedial from the posterior aspect of the mastoid process (posterior
neck) on each side with 3 pounds of pressure to determine if any tenderness is present, and
the subject will verbally give a pain rating between 0-10. This will be referred to as the
left and right cervical sites of tenderness (CSOT).
Next, using the IsoTouch finger sensor, the trigeminal nerve endings will be palpated for
tenderness with 2 lbs of pressure and subjects will verbally give a pain rating on a scale of
0-10 at the following sites: V1, and V2 branches of the trigeminal nerve on the face which
will be referred to as trigeminal tender points (TTPs, see below diagram). The three most
tender TTPs will be documented.
Two lbs of pressure will be used on the facial sites as the anatomy is significantly
different. The facial structures in general are much more superficial than the layers of
musculature in the posterior neck. Therefore, the pressure will be less on the face than it
is on the posterior neck musculature.
The operator will keep one monitoring sensor with minimal pressure (less than 0.5 lbs of
pressure) at the CSOT while the other sensor/sensing hand applies steady pressure to each of
the TTPs. The CSOT remains the same throughout the protocol and does not change sides, as it
will be reevaluated when the protocol is completed.
The three most tender TTPs will be palpated with steady pressure (two lbs of pressure) for 30
seconds, as this step is the neuromodulation intervention. In the event that there are two
tender points rated the same (and not zero), the investigators will repeat assessment of each
trigeminal area again to be rated by the subject. If it happens that the same values are
again recorded, the investigators will include both tender points in our protocol,
potentially including four TTPs in the intervention. Any anomalies will be noted in the data
collection. The steady pressure is continuously recorded via the pressure sensing IsoTouch
pads and monitored in real time by the operator to keep it consistent with each intervention.
After the TTP's have the intervention, their face will not be touched again.
After all three of the TTPs assessed to have tenderness have received the intervention, the
CSOT will be rechecked with the same initial pressure (3lbs) to evaluate pain changes.
For Example, The CSOT on the right was assessed to have an 8/10 tenderness to palpation. V1R,
V2R, V2L were found to have the most tenderness. In sequential order, V1R, V2R, V2L will have
the neuromodulatory pulsations applied to them, and when complete, the right sided CSOT will
be rechecked.
Due to the force signal drift of the ISOTOUCH, and the real-time nature of the software, the
pressure/force will be monitored and adjusted accordingly to maintain the appropriate
pressure/force throughout the intervention.
This neuromodulatory protocol is finished when the TTPs that were assessed to have the most
tenderness each had the 30 second intervention.
The protocol will be ended immediately if any subject asks to stop, or if any significant
pain or side effects develop.
