Effect of Palpatory Neuromodulation of the Trigeminal Nerve for Tenderness in the Posterior Neck Musculature

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.