Tissue PainOptMeasSkinNCT06390085
Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
A study testing Soft tissue manipulation in people with Tissue Pain, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Pain
- What is being tested?
- Soft tissue manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2024to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy or diagnosed with benign, non-vascular headache and associated cervical musculoskeletal dysfunction (e.g. tender spots, trigger points, stiffness.
- Adult male and female.
Who cannot join
- Migraine headaches.
- Known cardiovascular, pulmonary, or metabolic disease.
- Any co-morbidities that could contribute to back or neck pain (e.g., head trauma, cancer, seizures, tumors, radiculopathies, rheumatoid arthritis, systemic auto-immune or inflammatory conditions).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
About this study
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.
Read the 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.
- Upon arrival for the study, a participant will be asked to read, review, and sign this informed consent agreement.
- Next, the participant will be asked verbally to complete a demographic questionnaire.
- The study team will verbally ask the participant to rate the current level of pain.
- The participant will have been asked to bring clothes (e.g., sports bra, halter top, or swimming suit, etc.) to expose the upper back/neck region, and will change into those in an isolated room and within the overall laboratory space. A gown will be provided for additional privacy.
- 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.
- The study team will apply non-toxic, washable ink to the participant's back in two 10 by 10 cm areas near the shoulder blades on either side of the body.
- The participant will lie flat on a massage table.
- 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 participant's back. A participant's face will never be videotaped, nor will audio be recorded.
- 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
- A soft tissue intervention, or massage, lasting about 15 minutes will take place in the participant's upper back/neck region.
- Another assessment like that prior will be performed.
- The participant will again be verbally asked about the current level of pain.
- Conditions
- Tissue Pain
- Being tested
- Soft tissue manipulation
- Keywords
- myofascial tissue, skin surface, optical imaging, deformation
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue manipulationOther
The clinician will perform a soft tissue massage intervention where she/he will use moderate massaging and compression. The amount of pressure is less than 5 N, the velocity is low at a controlled rate of 1 Hz, the duration of 30 seconds, angle 90 and 45 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy intervention | Experimental | Those participants with myofascial pain in the cervicothoracic region are assessed by manual palpation by a trained clinician. Receives: Other: Soft tissue manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Stretch Response to Manual Lateral Pull
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).
Measured: Measured once at start and once at finish of one hour session per participant
Secondary outcomes (2)
Clinical Evaluation of Range of Motion
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.
Measured: Measured once at start and once at finish of one hour session per participant
Clinical Evaluation of Pressure Pain Threshold
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.
Measured: Measured once at start and once at finish of one hour session per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 Jan 2024
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tissue PainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluating objective imaging biomarkers for characterizing myofascial pain and mobility.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gregory J. Gerling, University of Virginia
- Investigators
- Gregory Gerling, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390085
- Sponsor's protocol ID
- IRBSBS6201
- Other IDs
- 5U24AT011969
- Acronym
- OptMeasSkin
- Status last verified
- Jan 2026
- First submitted
- 15 Feb 2024
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in the area of soft tissue manipulation.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
- ClinicalTrials.gov ID
- NCT06390085
- Acronym / sponsor ID
- OptMeasSkin / IRBSBS6201
- Conditions
- Tissue Pain
- Keywords
- myofascial tissue, skin surface, optical imaging, deformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Upon arrival for the study, a participant will be asked to read, review, and sign this informed consent agreement.
- Next, the participant will be asked verbally to complete a demographic questionnaire.
- The study team will verbally ask the participant to rate the current level of pain.
- The participant will have been asked to bring clothes (e.g., sports bra, halter top, or swimming suit, etc.) to expose the upper back/neck region, and will change into those in an isolated room and within the overall laboratory space. A gown will be provided for additional privacy.
- 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.
- The study team will apply non-toxic, washable ink to the participant's back in two 10 by 10 cm areas near the shoulder blades on either side of the body.
- The participant will lie flat on a massage table.
- 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 participant's back. A participant's face will never be videotaped, nor will audio be recorded.
- 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
- A soft tissue intervention, or massage, lasting about 15 minutes will take place in the participant's upper back/neck region.
- Another assessment like that prior will be performed.
- The participant will again be verbally asked about the current level of pain.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluating objective imaging biomarkers for characterizing myofascial pain and mobility.
| Arm | Type | Receives |
|---|---|---|
| Manual therapy intervention | Experimental | Other: Soft tissue manipulationThose participants with myofascial pain in the cervicothoracic region are assessed by manual palpation by a trained clinician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy or diagnosed with benign, non-vascular headache and associated cervical musculoskeletal dysfunction (e.g. tender spots, trigger points, stiffness.
- Adult male and female.
Key exclusion criteria (3 listed)
- Migraine headaches.
- Known cardiovascular, pulmonary, or metabolic disease.
- Any co-morbidities that could contribute to back or neck pain (e.g., head trauma, cancer, seizures, tumors, radiculopathies, rheumatoid arthritis, systemic auto-immune or inflammatory conditions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft tissue manipulationThe clinician will perform a soft tissue massage intervention where she/he will use moderate massaging and compression. The amount of pressure is less than 5 N, the velocity is low at a controlled rate of 1 Hz, the duration of 30 seconds, angle 90 and 45 degrees. | Other | Manual therapy intervention |
Primary outcome
Skin Stretch Response to Manual Lateral Pull
Time frame: Measured once at start and once at finish of one hour session per participant
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).
2 secondary outcomes
Clinical Evaluation of Range of Motion
Time frame: Measured once at start and once at finish of one hour session per participant
Clinical Evaluation of Pressure Pain Threshold
Time frame: Measured once at start and once at finish of one hour session per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in the area of soft tissue manipulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Gerling, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue manipulation in people with Tissue Pain, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Stretch Response to Manual Lateral Pull (time frame: Measured once at start and once at finish of one hour session per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.