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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05934695
• Other study ID #: 010/28202306
• Status: Completed
• Start date: June 30, 2023
• Est. completion date: January 3, 2024

Study information

• Verified date: January 2024
• Source: Ahram Canadian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder joint mobility	shoulder flexion, abduction, external rotation and extension range of motion measured using a digital inclinometer.	baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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