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

Not Applicable

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Other: Complex decongestive therapy; Device: Cryotherapy; Other: Kinesio taping

• Registration Number: NCT06327438
• Lead Sponsor: South Valley University

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

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study Start: 2024-03-16
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-06-16
• Study Completion: 2024-07-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (C)	Complex decongestive therapy	(n=20) received kinesio taping and complex decongestive therapy
Group (B)	Cryotherapy	(n=20) received cryotherapy and complex decongestive therapy
Group (A)	Complex decongestive therapy	(n=20) received complex decongestive therapy only
Group (B)	Complex decongestive therapy	(n=20) received cryotherapy and complex decongestive therapy
Group (C)	Kinesio taping	(n=20) received kinesio taping and complex decongestive therapy

Primary Outcome Measures

Name	Time	Method
Pain severity is measured by VAS	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")
Arm girth measurement is measured by Circumferential measurements	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.

Secondary Outcome Measures

Name	Time	Method
Range of motion (ROM) is measured by UG	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
The QOL is measured by SF-36	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

Trial Locations

Locations (1)

Ragaee Saeed Mahmoud; 🇪🇬 Faisal, Giza, Egypt