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Clinical Trials/NCT06327438
NCT06327438
Recruiting
Not Applicable

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

South Valley University1 site in 1 country60 target enrollmentStarted: March 16, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Pain severity is measured by VAS

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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")

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.

Secondary Outcomes

  • Range of motion (ROM) is measured by UG(12 consecutive weeks)
  • The QOL is measured by SF-36(12 consecutive weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ragaee Saeed Mahmoud

Lecturer

National Cancer Institute (NCI)

Study Sites (1)

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