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

NCT05934695 | Completed

• 1 other identifier: 010/28202306
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Shoulder flexors strength

  baseline

• Shoulder abductor strength

  baseline

• Self-reported upper extremity function

  baseline

Study Arms (3)

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

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

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

Interventions

Lymphedema severity stratification 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

Mild lymphedema (stage 1); Moderate lymphedema (stage 2); Severe lymphedema (stage 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: June 30, 2023
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)