Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial

March 22, 2024 updated by: Ragaee Saeed Mahmoud, South Valley University

Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema

To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B & C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Faisal
    • Giza
      • Faisal, Giza, Egypt, 002
        • Recruiting
        • Ragaee Saeed Mahmoud
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patients aged between 40 to 60 years. They were grade 2 and 3 lymphedema. They had more than 2 cm difference at circumference measurement. They had unilateral arm lymphedema post-mastectomy. They had completed chemotherapy and radiotherapy.

Exclusion Criteria:

Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (A)
(n=20) received complex decongestive therapy only
Other: Complex decongestive therapy
  1. Manual lymphatic drainage (MLD).
  2. Compression bandage.
  3. Exercises to enhance lymphatic drainage.
  4. Skin care.
Experimental: Group (B)
(n=20) received cryotherapy and complex decongestive therapy
Other: Complex decongestive therapy
  1. Manual lymphatic drainage (MLD).
  2. Compression bandage.
  3. Exercises to enhance lymphatic drainage.
  4. Skin care.
Device: Cryotherapy
It is a mature and safe-to-use system that cools the air to -32°C. Steps of application included: 1) Apply oil or cream to moisture the skin before cryotherapy application; 2) Initialize the mini cryo-air equipment at level 6.
Experimental: Group (C)
(n=20) received kinesio taping and complex decongestive therapy
Other: Complex decongestive therapy
  1. Manual lymphatic drainage (MLD).
  2. Compression bandage.
  3. Exercises to enhance lymphatic drainage.
  4. Skin care.
Other: Kinesio taping
It is a new choice in the field of physical therapy. The material used for the KT and the original concept of the taping technique were introduced by Dr Kenso Kase in 1973.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm girth measurement is measured by Circumferential measurements
Time Frame: 12 consecutive weeks
It is a valid and reliable method, its protocol was used throughout, with measures performed on both arms at the axilla, halfway from the axilla to the cubital fossa, cubital fossa, halfway from the cubital fossa to the wrist, and at the wrist.
12 consecutive weeks
Pain severity is measured by VAS
Time Frame: 12 consecutive weeks
It consisted of a line, often 10 cm long (100 mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be")
12 consecutive weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The QOL is measured by SF-36
Time Frame: 12 consecutive weeks
It is widely validated and popularly method that is used to evaluate QOL of the patients. Since then, the reliability and validity of the SF-36 questionnaire have been evaluated in a number of specific population world-wide
12 consecutive weeks
Range of motion (ROM) is measured by UG
Time Frame: 12 consecutive weeks
It is GONIO_PLASTIC_360, China, frequently used for measurement of shoulder ROM (flexion, abduction and external rotation) by physical therapists to assess ROM due to its ease of use, portability, noninvasive nature, and low cost
12 consecutive weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2024

Primary Completion (Estimated)

June 16, 2024

Study Completion (Estimated)

July 16, 2024

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/211/MTI.PT/2401041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Intervention

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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