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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06327438
Enrollment
60
Registered
2024-03-25
Start date
2024-03-16
Completion date
2024-07-16
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Complex Decongestive Therapy; Cryotherapy; Kinesio Taping; Lymphedema; Post-mastectomy

Brief summary

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

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

Interventions

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

DEVICECryotherapy

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.

OTHERKinesio 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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

randomized controlled study

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Arm girth measurement is measured by Circumferential measurements12 consecutive weeksIt 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.
Pain severity is measured by VAS12 consecutive weeksIt 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)

Secondary

MeasureTime frameDescription
The QOL is measured by SF-3612 consecutive weeksIt 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
Range of motion (ROM) is measured by UG12 consecutive weeksIt 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026