Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in muscle stiffness of the pectoralis major
研究概览
简要总结
The objective of the proposed study is to assess how myofascial massage alters stiffness and microvascular perfusion of shoulder muscles and how these changes are influenced by patient-therapist interactions.
The primary hypothesis is that stiffness of shoulder muscles will be decreased, and microvascular perfusion will be increased after a 30-minute myofascial massage, and that the addition of patient-therapist communication levels will result in greater changes with certain levels.
详细描述
Please note that there are certain details left off of this registration in order to collect information regarding certain aspects of the trial. These details (approved by the IRB) will be updated at the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous unilateral breast cancer diagnosis
- •Treatment for primary breast cancer was completed 3 months to 2 years prior to enrollment (defined as completion of all treatments except oral maintenance therapies)
- •Myofascial pain in upper quadrant of the chest
- •Ability to understand and willingness to sign a written informed consent.
排除标准
- •Chronic neuromuscular or orthopedic injury currently affecting upper extremity function that is unrelated to their cancer diagnosis
- •Currently undergoing physical therapy, occupational therapy or other treatment for side effects related to their cancer diagnosis or other injury to the upper extremity
- •History of fibromyalgia
- •Broken or bruised skin in the chest/shoulder area
- •Diagnosed with metastatic breast cancer
- •Currently receiving treatment for other forms of cancer
研究组 & 干预措施
Massage with Restricted Communication
Data was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
干预措施: Massage (Behavioral)
Massage with Full Communication
Data was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
干预措施: Massage (Behavioral)
结局指标
主要结局
Change in muscle stiffness of the pectoralis major
时间窗: Baseline, post massage (approximately 30 minutes and 60 minutes)
This will be assessed by ultrasound shear wave elastography before and after myofascial massage.
Change in Muscle Stiffness of the Pectoralis Major
时间窗: Baseline, post massage (approximately 5 minutes and 60 minutes)
This will be assessed by ultrasound shear wave elastography before and after myofascial massage. Reported as the average shear wave velocity value at the most medial inferior site imaged.
次要结局
- Change in muscle perfusion of the pectoralis major and upper trapezius(Baseline, post massage (approximately 30 minutes and 60 minutes))
- Change in muscle stiffness of the pectoralis major compared between groups(Baseline, post massage (approximately 30 minutes and 60 minutes))
- Global Satisfaction measured by the Patient Global Impression of Change will be compared between groups at the different communication levels(Approximately 60 minutes (during wait period after massage))
- Change in Muscle Perfusion of the Pectoralis Major(Baseline, post massage (approximately 5 minutes and 60 minutes))
- Global Satisfaction Measured by the Patient Global Impression of Change(Approximately 7 days post-intervention)
研究者
David B Lipps, PhD
Associate Professor of Kinesiology
University of Michigan