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

The Impact of Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors: A Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Cancer Female
• Intervention / Treatment: Other: Lymphedema severity stratification

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study aims to recruit women with different severity levels of breast cancer-related lymphedema, an upper limb condition that can result from breast cancer treatment causing swelling and other impairments. By assessing women at different points along the continuum of lymphedema severity, the impact of severity on shoulder function and related outcomes can be examined.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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
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.	Other: 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
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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder joint mobility	shoulder flexion, abduction, external rotation and extension range of motion measured using a digital inclinometer.	baseline
Muscle activation patterns (Amplitude)	Surface EMG recording of muscle activation patterns (amplitude) of the biceps brachii, anterior/middle/posterior deltoid, pectoralis major and latissimus dorsi during shoulder elevation. Amplitude will be reported in units of microvolts (µV)	baseline
Muscle activation patterns (Timing)	Surface EMG recording of muscle activation patterns (timing) of the biceps brachii, anterior/middle/posterior deltoid, pectoralis major and latissimus dorsi during shoulder elevation. Timing will be reported in units of milliseconds (ms).	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder flexors strength	Maximal shoulder flexor abductor strength measured as force production (N) using a handheld dynamometer. The average of 3 trials for each muscle group will be calculated.	baseline
Shoulder abductor strength	Maximal shoulder abductor strength measured as force production (N) using a handheld dynamometer. The average of 3 trials for each muscle group will be calculated.	baseline
Self-reported upper extremity function	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, developed by the Institute for Work and Health, is used to measure patient-reported functional outcomes. The DASH questionnaire consists of 30 questions regarding limitations to complete physical activities due to upper extremity pain/impairment. Participants will be asked to respond to each question based on their experiences over the preceding week according to a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to do). Responses will be scored out of 5 and averaged to produce a score out of 100 with higher scores representing greater disability.	baseline

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): January 3, 2024
• Study Completion (Actual): January 3, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: 010/28202306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No