Elastography Changes in Cesarean Scar After Negative Pulsed Pressure Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- elastography measurement
研究概览
简要总结
The application of pulsed negative pressure to the scar tissue stimulates the cellular response, producing elastic changes in the tissue, quantifiable by ultrasound, not only in terms of thickness but also in the elastic capacity of the tissues, measured by quantified elastography.
详细描述
Participants will be recruited at the "Clínica Ana González" physiotherapy clinic. Once recruited, the physiotherapist Ana González Muñoz will carry out the assessment to determine the degree of eligibility of said participants and their inclusion or not in the study. The present study is designed as an open, controlled clinical trial. Two evaluations will be carried out on each participant before and after treatment. Participants who meet the required inclusion/exclusion criteria determined below will be included.
Participants will receive a Negative Pulsed Pressure treatment program with the AeroFlow® equipment. The measuring instruments to be used will be:
- Ultrasound machine.
Description of the ultrasound evaluation
Ultrasound evaluations will be performed. The participant will remain in all measurements. All measurements will be performed with a General Electric S7 R3 The evaluation of tissue quality will be carried out by pixel quantification, using the computer software included in the ultrasound equipment itself.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants aged between 18 and 60 years
- •Who have undergone cesarean section surgery and therefore have a scar, lasting more than six months and less than 2 years.
- •Patients who present a post-cesarean section scar with a fibrotic appearance and possible surrounding fascial restrictions.
排除标准
- •Patients who present any neurological, inflammatory or orthopedic injury that prevents or alters balance, listening, vision or the cognitive abilities necessary to be able to answer appropriate questions or take questionnaires.
- •Patients who present keloids in the scar.
- •Patients who have contraindications to be treated with a 448kHz radiofrequency device such as:
- •to. pregnant women b. Subjects with any type of electronic implants. c. Subjects presenting with thrombophlebitis
结局指标
主要结局
elastography measurement
时间窗: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity.
次要结局
- Foot posture index(Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.)
- adheremeter measurement(Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.)
研究者
GONZÁLEZ-MUÑOZ, ANA
PhD Student, MSc
Universidad de Granada