Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

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.

Study Overview

• Status: Completed
• Conditions: Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes
• Intervention / Treatment: Other: Physiotherapy Treatment

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokky, Giza
    • Cairo, Dokky, Giza, Egypt
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Physiotherapy Treatment; Physical Therapy sessions for treatment of advanced Lymphedema Cases
Experimental: 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	Other: Physiotherapy Treatment; Physical Therapy sessions for treatment of advanced Lymphedema Cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb Volume	girth Limb Measurement	1 Month

Collaborators and Investigators

• Sponsor: Ahmed Mohamed Abdelrauf
• Investigators: Principal Investigator: Ahmed Mohamed Abdelrauf, Assistant Lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: P.T.REC/012/002271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: (all collected IPD, all IPD that underlie results in a publication)
• IPD Sharing Time Frame: Starting in December 2020 - March 2021
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No