Comparing an Electronic Approach to the Human Massage Therapist.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients enrolled
研究概览
简要总结
The purpose of this study is to gather information about patient experience receiving a massage through a robotic EMMA (Expert Manipulative Massage Automation) compared to receiving a massage from a massage therapist.
详细描述
Patients being evaluated in an outpatient service will be invited to participate in this study if they report a primary pain point in Low Back. Once they are enrolled in the study, they will be randomized to the type of massage therapy they will receive. Direct massage therapy through a certified massage therapist or indirect massage therapy through EMMA operated by a certified massage therapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18 years of age or older.
- •report a primary pain point in the lower back.
- •Pain intensity reported at baseline
- •Women of childbearing potential who self-report not being pregnant and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period
- •be able to participate fully in all aspects of the study.
- •have understood and signed study informed consent.
排除标准
- •Pregnancy or breastfeeding
- •Patients with the inability to stay in a prone position
- •Patients with bleeding disorders
- •Patients with allergies and/or local skin affectations
- •have used pain medications or participated in a pain treatment within three days of study enrollment.
- •have an implanted device (including a lap band) in the targeted area of massage therapy.
- •have used an investigational drug within 30 days of study enrollment.
- •have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
- •have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled diabetes type 2) active cancer, actively receiving treatment for cancer or within 1 year of cancer remission.
- •surgical intervention for pain within 1 month prior to enrollment.
- •active infection, wound or other external trauma to the areas to be treated with massage therapy.
- •have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
研究组 & 干预措施
Indirect person massage therapy
A massage therapist will program and direct an Artificial Intelligence Robotic Arm (EMMA) to deliver massage therapy. EMMA executes massages through soft treatment modules that are warmed to a temperature of between 38℃ and 40℃ to mimic human touch. This treatment will last approximately 20 minutes.
干预措施: EMMA massage therapy (Device)
Direct person massage therapy
Clinical massage treatment procedures are delivered by a clinically licensed massage therapist. This treatment will last approximately 20 minutes.
干预措施: Clinical massage treatment (Other)
结局指标
主要结局
Number of patients enrolled
时间窗: baseline to end of study (year 2)
Feasibility will be determined by the total number of patients screened in order to accrue the 40 needed to complete the study.
次要结局
未报告次要终点
研究者
Michael R. Mueller
Principal Investigator
Mayo Clinic