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

Completed

• Conditions: Breast Cancer Female; Breast Cancer
• Interventions: Other: Lymphedema severity stratification

• Registration Number: NCT05934695
• Lead Sponsor: Ahram Canadian University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study Start: 2023-06-30
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-07
• Status Verified: 2024-01
• Primary Completion: 2024-01-03
• Study Completion: 2024-01-03
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild lymphedema (stage 1)	Lymphedema severity stratification	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.
Moderate lymphedema (stage 2)	Lymphedema severity stratification	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.
Severe lymphedema (stage 3)	Lymphedema severity stratification	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.

Primary Outcome Measures

Name	Time	Method
Shoulder joint mobility	baseline	shoulder flexion, abduction, external rotation and extension range of motion measured using a digital inclinometer.
Muscle activation patterns (Amplitude)	baseline	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)
Muscle activation patterns (Timing)	baseline	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).

Secondary Outcome Measures

Name	Time	Method
Shoulder abductor strength	baseline	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.
Self-reported upper extremity function	baseline	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.
Shoulder flexors strength	baseline	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.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt