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

NCT06327438 | Recruiting DMC

• 1 other identifier: REC/211/MTI.PT/2401041
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Arm girth measurement is measured by Circumferential measurements

  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.

  12 consecutive weeks

• Pain severity is measured by VAS

  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")

  12 consecutive weeks

Secondary Outcomes (2)

• The QOL is measured by SF-36

  12 consecutive weeks

• Range of motion (ROM) is measured by UG

  12 consecutive weeks

Study Arms (3)

Group (A)

EXPERIMENTAL

(n=20) received complex decongestive therapy only

Other: Complex decongestive therapy

Group (B)

EXPERIMENTAL

(n=20) received cryotherapy and complex decongestive therapy

Other: Complex decongestive therapy; Device: Cryotherapy

Group (C)

EXPERIMENTAL

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

Other: Complex decongestive therapy; Other: Kinesio taping

Interventions

Complex decongestive therapy OTHER

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

Group (A); Group (B); Group (C)

Cryotherapy 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 (B)

Kinesio taping 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.

Group (C)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (2)

Ragaee Saeed Mahmoud

Giza, Faisal, Egypt

RECRUITING

Ragaee Saeed Mahmoud

Faisal, Giza Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: randomized controlled study

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 25, 2024
• Study Start: March 16, 2024
• Primary Completion: June 16, 2024
• Study Completion: July 16, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)