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

NCT ID: NCT06327438

Condition: Breast Neoplasms

Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema

Conditions: Keywords:
Complex Decongestive Therapy; Cryotherapy; Kinesio Taping; Lymphedema; Post-mastectomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: randomized controlled study

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Other
Intervention name: Complex decongestive therapy
Description: 1. Manual lymphatic drainage (MLD). 2. Compression bandage. 3. Exercises to enhance lymphatic drainage. 4. Skin care.
Arm group label: Group (A)
Arm group label: Group (B)
Arm group label: Group (C)

Intervention type: Device
Intervention name: Cryotherapy
Description: 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.
Arm group label: Group (B)

Intervention type: Other
Intervention name: Kinesio taping
Description: 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.
Arm group label: Group (C)

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

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 40 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Ragaee Saeed Mahmoud

Address:
City: Giza
Country: Egypt

Status: Recruiting

Contact:
Last name: Ragaee Mahmoud

Phone: 00201223611112
Email: ragaeesaeedpt10@gmail.com

Contact backup:
Last name: Reham Mahmoud

Phone: 00201015447798
Email: rsm_211pt@yahoo.com

Facility:
Name: Ragaee Saeed Mahmoud

Address:
City: Faisal
Zip: 002
Country: Egypt

Status: Recruiting

Contact:
Last name: Reham Saeed, Doctora

Phone: 00201223611112
Email: rsm_Pt211@yahoo.com

Contact backup:
Last name: Rabab Saeed, Doctora

Phone: 00201017855222
Email: rababSaeed10@yahoo.com

Start date: March 16, 2024

Completion date: July 16, 2024

Lead sponsor:
Agency: South Valley University
Agency class: Other

Source: South Valley University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06327438

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