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

Not Applicable
Completed
Conditions
Tissue Pain
Interventions
Other: Soft tissue manipulation
Registration Number
NCT06390085
Lead Sponsor
University of Virginia
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 (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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5
Inclusion Criteria
  • Healthy or diagnosed with benign, non-vascular headache and associated cervical musculoskeletal dysfunction (e.g. tender spots, trigger points, stiffness.
  • Adult male and female.
Exclusion Criteria
  • 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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Normal myofascial stiffnessSoft tissue manipulationThose participants with normal myofascial stiffness as assessed by palpation by a trained clinician.
Latent myofascial stiffnessSoft tissue manipulationThose participants with latent myofascial stiffness as assessed by palpation by a trained clinician.
Active myofascial stiffnessSoft tissue manipulationThose participants with active myofascial stiffness as assessed by palpation by a trained clinician.
Primary Outcome Measures
NameTimeMethod
Clinician evaluation of range of motionMeasured during the 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.

Skin stretch response to manual lateral pullMeasured during the 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 stretch/strain (which is a unitless quantity) against manual pull (which is measured as maximum displacement, in units millimeters) for each of the four directions of pull (superior, inferior, lateral, medial).

Clinician judgment of tissue stateMeasured during the one hour session per participant

The assessing clinician will record a description of tissue state upon palpation examination, as either normal, latent, active, or both latent and active.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

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