Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors

NCT ID: NCT05934695

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-01-03

Brief Summary

Breast cancer-related lymphedema (BCRL) is a common complication affecting the upper extremity following breast cancer treatment. This study aims to investigate the relationship between lymphedema severity and shoulder joint function and muscle activation patterns in breast cancer survivors.

Conditions

Breast Cancer; Breast Cancer Female

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mild lymphedema (stage 1)

International Society of Lymphology lymphedema severity stage 1, characterized by swelling with pitting, normal skin and tissue turgor. Participants assigned to this group will have mild swelling and tightness of the arm.

Lymphedema severity stratification

Intervention Type: OTHER

Participants will be stratified into one of three lymphedema severity groups based on the International Society of Lymphology lymphedema severity staging:

Mild (stage 1): swelling with pitting; normal skin and tissue turgor Moderate (stage 2): swelling with pitting; dermal thickening; skin changes without distortional warty-overgrowth Severe (stage 3): swelling with non-pitting; warty overgrowth or elephantiasis folds

Moderate lymphedema (stage 2)

International Society of Lymphology lymphedema severity stage 2, characterized by swelling with pitting as well as skin and tissue changes such as dermal thickening. Participants assigned to this group will have moderate swelling and tightness of the arm as well as skin changes without distortional warty-overgrowth or elephantiasis folds.

Lymphedema severity stratification

Intervention Type: OTHER

Participants will be stratified into one of three lymphedema severity groups based on the International Society of Lymphology lymphedema severity staging:

Mild (stage 1): swelling with pitting; normal skin and tissue turgor Moderate (stage 2): swelling with pitting; dermal thickening; skin changes without distortional warty-overgrowth Severe (stage 3): swelling with non-pitting; warty overgrowth or elephantiasis folds

Severe lymphedema (stage 3)

International Society of Lymphology lymphedema severity stage 3, characterized by swelling with non-pitting, and warty-overgrowth or elephantiasis folds of skin. Participants assigned to this group will have severe swelling and tightness of the arm with warty overgrowth of skin.

Lymphedema severity stratification

Intervention Type: OTHER

Participants will be stratified into one of three lymphedema severity groups based on the International Society of Lymphology lymphedema severity staging:

Mild (stage 1): swelling with pitting; normal skin and tissue turgor Moderate (stage 2): swelling with pitting; dermal thickening; skin changes without distortional warty-overgrowth Severe (stage 3): swelling with non-pitting; warty overgrowth or elephantiasis folds

Interventions

Lymphedema severity stratification

Participants will be stratified into one of three lymphedema severity groups based on the International Society of Lymphology lymphedema severity staging:

Mild (stage 1): swelling with pitting; normal skin and tissue turgor Moderate (stage 2): swelling with pitting; dermal thickening; skin changes without distortional warty-overgrowth Severe (stage 3): swelling with non-pitting; warty overgrowth or elephantiasis folds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female
• Adults (18 years or older)
• Diagnosis of breast cancer-related lymphedema for a minimum of 3 months
• No current evidence of active cancer
• Able to provide informed consent

Exclusion Criteria

• Pre-existing musculoskeletal conditions affecting the upper extremities (e.g. adhesive capsulitis, rotator cuff tear)
• Previous upper extremity surgery
• Physical inability to perform the required physical movements and assessments

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

010/28202306

Identifier Type: -

Identifier Source: org_study_id