Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390085
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-02-15
Brief Title:
Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
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:
OptMeasSkin
Brief Summary:
This study involves imaging the skin movements of surface tissue on the back A clinician will perform assessment and intervention procedures manually using manual and light movements of stretch and compression
Detailed Description:
This study includes a demographic questionnaire self-report on level of pain application of ink to the skin manual clinical assessments and a massage intervention The study will take place entirely in Olsson Hall All information collected will be recorded using a randomized identification number
1 Upon arrival for the study a participant will be asked to read review and sign this informed consent agreement
2 Next the participant will be asked verbally to complete a demographic questionnaire
3 The study team will verbally ask the participant to rate the current level of pain
4 The participant will have been asked to bring clothes eg sports bra halter top or swimming suit etc to expose the upper backneck region and will change into those in an isolated room and within the overall laboratory space A gown will be provided for additional privacy
5 Two researchers will be in the room during the session with the gender of the researchers taken into account per participant For example for a male participant the investigators plan to have a male researcher present during the session along with the female physical therapist For a female participant the investigators plan to have both the female physical therapist and a female researcher present
6 The study team will apply non-toxic washable ink to the participants back in two 10 by 10 cm areas near the shoulder blades on either side of the body
7 The participant will lie flat on a massage table
8 A camera system will record the movements of the fingers of the physical therapist along with the movements of the skin The investigators will videotape the upper part of the participants back A participants face will never be videotaped nor will audio be recorded
9 The physical therapist will conduct standard assessment procedures for about 2 minutes per side of the body where the skin tissue will be compressed and slightly stretched
10 A soft tissue intervention or massage lasting about 15 minutes will take place in the participants upper backneck region
11 Another assessment like that prior will be performed
12 The participant will again be verbally asked about the current level of pain
1 Upon arrival for the study a participant will be asked to read review and sign this informed consent agreement
2 Next the participant will be asked verbally to complete a demographic questionnaire
3 The study team will verbally ask the participant to rate the current level of pain
4 The participant will have been asked to bring clothes eg sports bra halter top or swimming suit etc to expose the upper backneck region and will change into those in an isolated room and within the overall laboratory space A gown will be provided for additional privacy
5 Two researchers will be in the room during the session with the gender of the researchers taken into account per participant For example for a male participant the investigators plan to have a male researcher present during the session along with the female physical therapist For a female participant the investigators plan to have both the female physical therapist and a female researcher present
6 The study team will apply non-toxic washable ink to the participants back in two 10 by 10 cm areas near the shoulder blades on either side of the body
7 The participant will lie flat on a massage table
8 A camera system will record the movements of the fingers of the physical therapist along with the movements of the skin The investigators will videotape the upper part of the participants back A participants face will never be videotaped nor will audio be recorded
9 The physical therapist will conduct standard assessment procedures for about 2 minutes per side of the body where the skin tissue will be compressed and slightly stretched
10 A soft tissue intervention or massage lasting about 15 minutes will take place in the participants upper backneck region
11 Another assessment like that prior will be performed
12 The participant will again be verbally asked about the current level of pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U24AT011969 | NIH | None | httpsreporternihgovquickSearch5U24AT011969 |