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| ID | Type | Description | Link |
|---|---|---|---|
| 5U24AT011969 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual therapy intervention | Experimental | Those participants with myofascial pain in the cervicothoracic region are assessed by manual palpation by a trained clinician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft tissue manipulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 once at start and once at finish of one hour session per participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Gerling, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
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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Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access to individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact gg7h@virginia.edu
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No pre-assignment exclusions were applied. All participants who enrolled proceeded directly to study assignment.
Participants were recruited in January 2024 from university academic setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | %/mm | Measured once at start and once at finish of one hour session per participant |
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From enrollment until end of follow-up, up to 1 week.
Adverse events were monitored throughout the intervention and post-assessment period. The licensed clinician completed standardized post-intervention assessment and follow-up check-in with participants a few hours after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Gerling | University of Virginia, Systems and Information Engineering | 4349240533 | gg7h@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2023 | Oct 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2023 | Oct 6, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2023 | Oct 20, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Evaluating objective imaging biomarkers for characterizing myofascial pain and mobility.
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| 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 once at start and once at finish of one hour session per participant |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Self-reported pain | Pain self-reported on a scale of 0 (no pain) to 10 (worst pain) for cervicothoracic region. | Mean | Standard Deviation | Scores on a scale |
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| 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. | Posted | Apr 2024 | Mean | Standard Deviation | Degrees | Measured once at start and once at finish of one hour session per participant |
|
|
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| 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. | Posted | Mean | Standard Deviation | Newtons | Measured once at start and once at finish of one hour session per participant |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| Title | Measurements |
|---|---|
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| Lateral flexion, pre-intervention |
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| Extension, post-intervention |
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| Flexion, post-intervention |
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| Rotation, post-intervention |
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| Lateral flexion, post-intervention |
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