Trial Outcomes & Findings for Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness (NCT NCT06390085)

Last Updated: 2025-11-06

Results Overview

In the study overall, a non-invasive surface skin imaging technique with three cameras is used to determine soft tissue deformation and mobility. Using this basis of data, this outcome measure characterizes the skin's stretch response to the manual application of lateral pull perpendicular to it's surface, as the clinician pulls the tissue lateral to its surface with her fingertips. Therefore, from this data, the specific outcome measure is 1st principal strain (%) against manual pull (which is measured as maximum displacement, in units millimeters) for each of the two directions of pull (superior - towards neck, inferior - away from neck).

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Measured once at start and once at finish of one hour session per participant

Results posted on

2025-11-06

Participant Flow

Participants were recruited in April 2024 from university academic setting.

No pre-assignment exclusions were applied. All participants who enrolled proceeded directly to study assignment.

Participant milestones

Participant milestones
Measure	Manual therapy intervention All participants with myofascial pain in the cervicothoracic region were assessed by a trained and licensed clinician, then received a standardized 15-minute manual therapy intervention. Outcomes were measured both immediately before and after the intervention to evaluate changes in tissue mobility and pain.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Manual therapy intervention n=5 Participants All participants with myofascial pain in the cervicothoracic region were assessed by a trained and licensed clinician, then received a standardized 15-minute manual therapy intervention. Outcomes were measured both immediately before and after the intervention to evaluate changes in tissue mobility and pain.
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=49 Participants
Age, Categorical >=65 years	1 Participants n=49 Participants
Sex: Female, Male Female	3 Participants n=49 Participants
Sex: Female, Male Male	2 Participants n=49 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants
Race (NIH/OMB) Asian	1 Participants n=49 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants
Race (NIH/OMB) Black or African American	0 Participants n=49 Participants
Race (NIH/OMB) White	4 Participants n=49 Participants
Race (NIH/OMB) More than one race	0 Participants n=49 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=49 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=49 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants
Self-reported pain	3.4 Scores on a scale STANDARD_DEVIATION 2.4 • n=49 Participants

PRIMARY outcome

Timeframe: Measured once at start and once at finish of one hour session per participant

Outcome measures

Outcome measures
Measure	Manual therapy intervention n=5 Participants All participants with myofascial pain in the cervicothoracic region were assessed by a trained and licensed clinician, then received a standardized 15-minute manual therapy intervention. Outcomes were measured both immediately before and after the intervention to evaluate changes in tissue mobility and pain.
Skin Stretch Response to Manual Lateral Pull Superior direction, pre-intervention	0.512 %/mm Standard Deviation 0.131
Skin Stretch Response to Manual Lateral Pull Inferior direction, pre-intervention	0.494 %/mm Standard Deviation 0.128
Skin Stretch Response to Manual Lateral Pull Superior direction, post-intervention	0.508 %/mm Standard Deviation 0.178
Skin Stretch Response to Manual Lateral Pull Inferior direction, post-intervention	0.473 %/mm Standard Deviation 0.095

SECONDARY outcome

Timeframe: Measured once at start and once at finish of one hour session per participant

The assessing clinician will record the range of motion (ROM) of the neck with the subject in the upright, seated position, using a head mounted inclinometer system (Cervical Range-of-Motion Instrument Basic). Cervical ROM will be assessed bilaterally in four directions, a) extension, b) flexion, c) rotation, and d) lateral flexion. Units of degrees will be recorded per each motion.

Outcome measures

Outcome measures
Measure	Manual therapy intervention n=5 Participants All participants with myofascial pain in the cervicothoracic region were assessed by a trained and licensed clinician, then received a standardized 15-minute manual therapy intervention. Outcomes were measured both immediately before and after the intervention to evaluate changes in tissue mobility and pain.
Clinical Evaluation of Range of Motion Extension, pre-intervention	62.40 Degrees Standard Deviation 18.24
Clinical Evaluation of Range of Motion Flexion, pre-intervention	43.60 Degrees Standard Deviation 8.76
Clinical Evaluation of Range of Motion Rotation, pre-intervention	54.70 Degrees Standard Deviation 20.17
Clinical Evaluation of Range of Motion Lateral flexion, pre-intervention	33.20 Degrees Standard Deviation 9.81
Clinical Evaluation of Range of Motion Extension, post-intervention	68.80 Degrees Standard Deviation 16.77
Clinical Evaluation of Range of Motion Flexion, post-intervention	47.20 Degrees Standard Deviation 9.44
Clinical Evaluation of Range of Motion Rotation, post-intervention	54.20 Degrees Standard Deviation 18.91
Clinical Evaluation of Range of Motion Lateral flexion, post-intervention	39.60 Degrees Standard Deviation 12.64

SECONDARY outcome

Timeframe: Measured once at start and once at finish of one hour session per participant

The assessing clinician will use Algometry to quantify pressure pain threshold (PPT), defined as the minimum pressure applied with a handheld algometer at which the sensation changed from pressure to discomfort. Units of Newtons will be recorded.

Outcome measures

Outcome measures
Measure	Manual therapy intervention n=5 Participants All participants with myofascial pain in the cervicothoracic region were assessed by a trained and licensed clinician, then received a standardized 15-minute manual therapy intervention. Outcomes were measured both immediately before and after the intervention to evaluate changes in tissue mobility and pain.
Clinical Evaluation of Pressure Pain Threshold Post-intervention	38.70 Newtons Standard Deviation 14.31
Clinical Evaluation of Pressure Pain Threshold Pre-intervention	32.10 Newtons Standard Deviation 14.94

Adverse Events

Manual therapy intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gregory Gerling

University of Virginia, Systems and Information Engineering

Phone: 4349240533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place