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临床试验/NCT06390085
NCT06390085已完成不适用

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

University of Virginia1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Skin Stretch Response to Manual Lateral Pull

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy or diagnosed with benign, non-vascular headache and associated cervical musculoskeletal dysfunction (e.g. tender spots, trigger points, stiffness.
  • Adult male and female.

排除标准

  • 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).

研究组 & 干预措施

Manual therapy intervention

Experimental

Those participants with myofascial pain in the cervicothoracic region are assessed by manual palpation by a trained clinician.

干预措施: Soft tissue manipulation (Other)

结局指标

主要结局

Skin Stretch Response to Manual Lateral Pull

时间窗: 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).

次要结局

  • Clinical Evaluation of Range of Motion(Measured once at start and once at finish of one hour session per participant)
  • Clinical Evaluation of Pressure Pain Threshold(Measured once at start and once at finish of one hour session per participant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory J. Gerling

Principal Investigator

University of Virginia

研究点 (1)

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