지방부종 수술의 물리치료
지방부종 수술의 수술 직후 단계에서 물리치료 중재
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
Madrid
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Alcalá de Henares, Madrid, 스페인, 28823
- Ester Cerezo Tellez
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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).
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: ECOLOGIC_OR_COMMUNITY
- 시간 관점: RETROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Visual Analogue Scale
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
edema resorption - volume
기간: 2018-2022
|
lower limb edema is measured |
2018-2022
|
|
complications reported - binary outcome
기간: 2018-2022
|
seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema |
2018-2022
|
|
mobility - scale
기간: 2018-2022
|
1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement |
2018-2022
|
|
patient satisfaction
기간: 2018-2022
|
binary outcome |
2018-2022
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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