脂肪水肿手术中的物理治疗
脂肪水肿手术术后即刻的物理治疗干预
The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery.
The main question it aims to answer are:
- if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days
- if the treatment is effective on preventing complications of these participants after surgery
Participants have been treated in the lasts years and authors recover information of the effects of the treatment.
Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received
研究概览
地位
详细说明
Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery.
Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.
A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Madrid
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Alcalá de Henares、Madrid、西班牙、28823
- Ester Cerezo Tellez
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid and were treated in a private physical therapy center. After surgery they were recommended to receive CDT by their surgeons. All participants received the same physical therapy treatment. The study was approved by the Clinical Research Committee of Hospital Universitario Principe de Asturias (CEIm 36/2023).
描述
Inclusion Criteria:
- female subject who underwent a lipedema surgery
- recommendation of the surgeon to receive physical therapy
Exclusion Criteria:
- unilateral surgery
- lack of data in the clinical history
- only 1-2 physical therapy sessions
学习计划
研究是如何设计的？
设计细节
- 观测模型：ECOLOGIC_OR_COMMUNITY
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
modified CDT physical therapy protocol, based on Godoy's Method
A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received. A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of
|
modified CDT physical therapy protocol |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Visual Analogue Scale
大体时间：Baseline, short-term (post-treatment), and 90 days follow-up
|
Pain assessed using the Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain. |
Baseline, short-term (post-treatment), and 90 days follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
edema resorption - volume
大体时间：2018-2022
|
lower limb edema is measured |
2018-2022
|
|
complications reported - binary outcome
大体时间：2018-2022
|
seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema |
2018-2022
|
|
mobility - scale
大体时间：2018-2022
|
1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement |
2018-2022
|
|
patient satisfaction
大体时间：2018-2022
|
binary outcome |
2018-2022
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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