Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

NCT ID: NCT04749342

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-05-01

Brief Summary

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The purpose of this study is to:

Find out the efficacy of using complete decongestive physiotherapy on limb volume in advanced secondary upper and lower extremity lymphedema patients.

Find out the efficacy of compression bandaging on limb volume in advanced lymphedema patients.

This study was conducted to compare between the efficacy of complete decongestive therapy (CDT) and compression bandaging in advanced secondary lower extremity lymphedema.

Detailed Description

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The study was conducted at the department of plastic surgery, Kasr Al-Ainy hospital. Sixty patients of both genders aged from 40 to 55 years old were participated in this study, and they were randomly assigned to two study groups.

Group I: Thirty patients received CDT (60 min of manual lymph drainage MLD, compression bandaging, exercises, and skin care).

Group II: Thirty patients received compression bandaging alone. The same bandaging scheme used for both groups. The therapy included 12 interventions performed 5 days a week, during the first two weeks in addition to another successive two sessions at the third week, i.e., for a total of twelve sessions.

Evaluation of limb volume using water volumetry and 4-cm truncated cone circumferential measurements were done before treatment application, after 6 sessions (post 1) and after 12 sessions (post 2).

Conditions

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Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The purpose of this report is to compare short-term outcomes of complete decongestive therapy and compression bandaging on patients with advanced secondary upper and lower extremity lymphedema.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Complete Decongestive Therapy

Complete decongestive therapy (CDT) is also known as complex decongestive therapy. It involves a two-stage treatment protocol. The first stage consists of skin care, manual lymph drainage, exercises and compression with multi-layered bandages. The second stage aims to optimize and conserve the volume reduction obtained in stage one. This is achieved by using a low-stretch elastic garment in combination with skin care and exercises

Group Type EXPERIMENTAL

Physiotherapy Treatment

Intervention Type OTHER

Physical Therapy sessions for treatment of advanced Lymphedema Cases

Compression Bandaging

External compression is the mainstay of management for all stages of lymphedema. The efficacy of compression therapy alone, or combined with MLD, has been supported by randomized clinical trials

Group Type EXPERIMENTAL

Physiotherapy Treatment

Intervention Type OTHER

Physical Therapy sessions for treatment of advanced Lymphedema Cases

Interventions

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Physiotherapy Treatment

Physical Therapy sessions for treatment of advanced Lymphedema Cases

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients with lower limb lymphedema (stage II and III) secondary lymphedema aged from 40 to 55 years old, with BMI less than 35 and duration of illness ranged from 3-9 years were included in the study

Exclusion Criteria

the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmed Mohamed Abdelrauf

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abdelrauf

Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Mohamed Abdelrauf, Assistant Lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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cairo University

Cairo, Dokky, Giza, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/002271

Identifier Type: -

Identifier Source: org_study_id

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