Tissue Pain
Conditions
Keywords
myofascial tissue, skin surface, optical imaging, deformation
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.
Interventions
OTHERSoft 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Evaluating objective imaging biomarkers for characterizing myofascial pain and mobility.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Stretch Response to Manual Lateral Pull | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evaluation of Range of Motion | 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. |
| Clinical Evaluation of Pressure Pain Threshold | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in January 2024 from university academic setting.
Pre-assignment details
No pre-assignment exclusions were applied. All participants who enrolled proceeded directly to study assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Manual Therapy Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Self-reported pain | 3.4 Scores on a scale STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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).
Time frame: Measured once at start and once at finish of one hour session per participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Therapy Intervention | Skin Stretch Response to Manual Lateral Pull | Superior direction, pre-intervention | 0.512 %/mm | Standard Deviation 0.131 |
| Manual Therapy Intervention | Skin Stretch Response to Manual Lateral Pull | Inferior direction, pre-intervention | 0.494 %/mm | Standard Deviation 0.128 |
| Manual Therapy Intervention | Skin Stretch Response to Manual Lateral Pull | Superior direction, post-intervention | 0.508 %/mm | Standard Deviation 0.178 |
| Manual Therapy Intervention | Skin Stretch Response to Manual Lateral Pull | Inferior direction, post-intervention | 0.473 %/mm | Standard Deviation 0.095 |
Secondary
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.
Time frame: Measured once at start and once at finish of one hour session per participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Therapy Intervention | Clinical Evaluation of Pressure Pain Threshold | Post-intervention | 38.70 Newtons | Standard Deviation 14.31 |
| Manual Therapy Intervention | Clinical Evaluation of Pressure Pain Threshold | Pre-intervention | 32.10 Newtons | Standard Deviation 14.94 |
Secondary
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.
Time frame: Measured once at start and once at finish of one hour session per participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Extension, pre-intervention | 62.40 Degrees | Standard Deviation 18.24 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Flexion, pre-intervention | 43.60 Degrees | Standard Deviation 8.76 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Rotation, pre-intervention | 54.70 Degrees | Standard Deviation 20.17 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Lateral flexion, pre-intervention | 33.20 Degrees | Standard Deviation 9.81 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Extension, post-intervention | 68.80 Degrees | Standard Deviation 16.77 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Flexion, post-intervention | 47.20 Degrees | Standard Deviation 9.44 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Rotation, post-intervention | 54.20 Degrees | Standard Deviation 18.91 |
| Manual Therapy Intervention | Clinical Evaluation of Range of Motion | Lateral flexion, post-intervention | 39.60 Degrees | Standard Deviation 12.64 |