Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793086
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-03-19
Brief Title:
Evaluation of a Novel Class of Objective Myofascial Pain Assessments
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Electrophysiological and Ultrasound Quantitative Biomarkers for Myofascial Pain
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENCOMPASS
Brief Summary:
This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study Electrical impedance myography EIM myofiber threshold tracking TT excitability testing and ultrasound with shear wave elastography SWE measurements will be obtained from the trapezius muscle the muscle that extends over the back of the neck and shoulders These measurements will be repeated within 2-5 days to assess repeatability of these methods
Detailed Description:
Study Visit One
1 Overview
2 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
3 Electrical Impedance Myography EIM - a trained technician will apply several small sticky pads electrodes to different parts of the subjects 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
4 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
5 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
6 Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain mood and sleep Overall this visit will take approximately 1 - 15 hours
Home Period Subjects will be asked to re-inforcere-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 subjects trigger points again at the beginning of the visit This visit will also last approximately 1-15 hours
1 Overview
2 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
3 Electrical Impedance Myography EIM - a trained technician will apply several small sticky pads electrodes to different parts of the subjects 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
4 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
5 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
6 Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain mood and sleep Overall this visit will take approximately 1 - 15 hours
Home Period Subjects will be asked to re-inforcere-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 subjects trigger points again at the beginning of the visit This visit will also last approximately 1-15 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None