Evaluation of a Novel Class of Objective Myofascial Pain Assessments

Study Visit One:

Overview

History and examination (All participants). After reviewing the purpose and procedures of the study, the subject, or a legally authorized representative (LAR), will be asked to sign the internal review board-approved informed consent form.

Basic medical, social, and family histories will then be obtained and recorded. Previous medical records will be reviewed. Medications, including drug doses, history of recent medication changes, and duration of treatment) will be reviewed.

A brief physical exam will be performed. If the subject has MPS, the study doctor will identify the trigger points and will mark those with a permanent marker.

Electrical Impedance Myography (EIM) - a trained technician will apply several small sticky pads (electrodes) to different parts of the subject's muscle and a very tiny electrical current will be applied that they will not feel. Several measurements will be done their muscle. This will take approximately 10 minutes

Ultrasound (US) - a trained technician will apply a small amount of gel to the skin. They will hold a small hand-held device on the skin and will measure the muscle. The gel is easily cleaned off of the skin when the testing is complete. This will take approximately 20 minutes

Threshold Tracking (TT) - TT tests how quickly muscle responds to stimulation. The muscle is stimulated using a small needle which is placed superficially in their trapezius muscle. The subject will feel a small needle prick which should be less uncomfortable than having blood drawn. Electrodes (small sticky pads) are placed a short distance from the needle over the muscle. When their muscle is stimulated with the needle, the time it takes for the muscle to react is measured by the electrodes. This procedure will last 30 minutes and creates a tingling feeling.

Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain, mood, and sleep. Overall, this visit will take approximately 1 - 1.5 hours.

Home Period Subjects will be asked to re-inforce/re-apply the permanent marker spots made at their first visit. This is so investigators can use the same spots for testing at the next visit.

Study Visit 2 (2-14 days after Study Visit #1) The second study visit is identical to the first one. A study team member will test the subject's trigger points again at the beginning of the visit. This visit will also last approximately 1-1.5 hours.