Effect of HIFEM Application on Musculoskeletal System: Evaluation of Musculoskeletal System Improvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Musculoskeletal System Perception
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of the BTL-899 device on improving the Musculoskeletal System in healthy adult volunteers. The main question it aims to answer is:
Whether the BTL-899 device is able to change musculoskeletal system perception before and after treatment, based on the Subject Satisfaction questionnaire.
Participants will complete four treatments, and two follow-up visits.
详细描述
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in the musculoskeletal system, specifically of the upper and lower extremities. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the study device.
At the baseline visit, the subject's weight will be recorded and subjects will fill in the Western Ontario and McMaster Universities questionnaire.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the designated area. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Therapy Comfort, Subject Satisfaction Questionnaire and Western Ontario and McMaster Universities questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22 years and older
- •Voluntarily signed an informed consent form
- •BMI ≤ 35 kg/m2
- •Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
- •Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
- •Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change in either direction during study participation
排除标准
- •Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- •Metal implants
- •Drug pumps
- •Malignant tumor
- •Pulmonary insufficiency
- •Application over muscles in acute phase of injury
- •Cardiovascular diseases
- •Disturbance of temperature or pain perception
- •Hemorrhagic conditions, blood coagulation disorders or anticoagulation therapy.
- •Septic conditions and empyema
- •Acute inflammations
- •Systemic or local infection such as osteomyelitis and tuberculosis
- •Contagious skin disease
- •Elevated body temperature
- •Pregnancy, postpartum period, nursing, and menstruation
- •A metal-containing intrauterine device (IUD)
- •Graves' disease
结局指标
主要结局
Musculoskeletal System Perception
时间窗: 15 months
The evaluation of changes in musculoskeletal system perception before and after treatment will be based on the 5-point Likert Scale Subject Satisfaction questionnaire. Responses to questions about the treated musculoskeletal area will range from "strongly agree" (1 point) to "strongly disagree" (5 points). A higher score for each statement indicate better outcomes. The Subject Satisfaction Questionnaire will be administered after the final treatment, as well as at the 1-month and 3-month follow-up visits.
次要结局
- Incidence of Treatment-related Adverse Events(15 months)
- Comfort Assessed by Therapy Comfort Questionnaire(15 months)
- Physical Function Assessed by the Western Ontario and McMaster Universities questionnaire.(15 months)