Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
NCT ID: NCT06390085
Last Updated: 2025-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2024-04-20
2024-04-22
Brief Summary
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Detailed Description
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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 (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.
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 participant's 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 participant's back. A participant's 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 participant's upper back/neck region.
11. Another assessment like that prior will be performed.
12. The participant will again be verbally asked about the current level of pain.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Manual therapy intervention
Those participants with myofascial pain in the cervicothoracic region are assessed by manual palpation by a trained clinician.
Soft tissue manipulation
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.
Interventions
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Soft tissue manipulation
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.
Eligibility Criteria
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Inclusion Criteria
* Adult male and female.
Exclusion Criteria
* 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).
18 Years
75 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Virginia
OTHER
Responsible Party
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Gregory J. Gerling
Principal Investigator
Principal Investigators
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Gregory Gerling, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRBSBS6201
Identifier Type: -
Identifier Source: org_study_id