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

NCT ID: NCT06327438

Last Updated: 2024-03-25

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-16

Study Completion Date

2024-07-16

Brief Summary

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

Detailed Description

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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

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group (A)

(n=20) received complex decongestive therapy only

Group Type EXPERIMENTAL

Complex decongestive therapy

Intervention Type OTHER

1. Manual lymphatic drainage (MLD).
2. Compression bandage.
3. Exercises to enhance lymphatic drainage.
4. Skin care.

Group (B)

(n=20) received cryotherapy and complex decongestive therapy

Group Type EXPERIMENTAL

Complex decongestive therapy

Intervention Type OTHER

1. Manual lymphatic drainage (MLD).
2. Compression bandage.
3. Exercises to enhance lymphatic drainage.
4. Skin care.

Cryotherapy

Intervention Type DEVICE

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.

Group (C)

(n=20) received kinesio taping and complex decongestive therapy

Group Type EXPERIMENTAL

Complex decongestive therapy

Intervention Type OTHER

1. Manual lymphatic drainage (MLD).
2. Compression bandage.
3. Exercises to enhance lymphatic drainage.
4. Skin care.

Kinesio taping

Intervention Type OTHER

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.

Interventions

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Complex decongestive therapy

1. Manual lymphatic drainage (MLD).
2. Compression bandage.
3. Exercises to enhance lymphatic drainage.
4. Skin care.

Intervention Type OTHER

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Ragaee Saeed Mahmoud

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ragaee Saeed Mahmoud

Giza, Faisal, Egypt

Site Status RECRUITING

Ragaee Saeed Mahmoud

Faisal, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ragaee Mahmoud

Role: primary

00201223611112

Reham Mahmoud

Role: backup

00201015447798

Reham Saeed, Doctora

Role: primary

00201223611112

Rabab Saeed, Doctora

Role: backup

00201017855222

Other Identifiers

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REC/211/MTI.PT/2401041

Identifier Type: -

Identifier Source: org_study_id

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