Clinical trial NCT06390085: Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
Official title: Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Pain
Keywords: myofascial tissue
skin surface
optical imaging
deformation
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-04-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluating objective imaging biomarkers using imaging for differentiating myofascial pain states.
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Skin stretch response to manual lateral pull
timeFrame: Measured during the one hour session per participant
measure: Clinician judgment of tissue state
timeFrame: Measured during the one hour session per participant
measure: Clinician evaluation of range of motion
timeFrame: Measured during the one hour session per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Gregory Gerling, PhD
role: PRINCIPAL_INVESTIGATOR
References: