Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF
研究概览
简要总结
The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: male and female
- •Age: 35-85 years include
- •Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery
- •Absence in history of neurological or psychiatric disorders.
- •Signature of the Informed Consent and consent to collaborate in all the procedures of the study
排除标准
- •Presence of severe neurological / psychiatric pathologies
- •to sign the Informed Consense
- •of serious cardiological pathologies that can compromise patient safety
- •of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments
- •of active tumors in the treatment area
结局指标
主要结局
change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF
时间窗: at the end of Cycle 5 ( every cycle during 5 days)
次要结局
未报告次要终点