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Clinical Trials/NCT05680116
NCT05680116
Completed
N/A

The Effect of Wearable Vibration Therapy on Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery

Acibadem University1 site in 1 country38 target enrollmentFebruary 1, 2023
ConditionsBreast Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Acibadem University
Enrollment
38
Locations
1
Primary Endpoint
Muscle strength
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of our study is to investigate the effect of vibration therapy to be applied to patients undergoing breast cancer surgery and adjuvant radiotherapy on upper extremity joint range of motion, muscle strength, grip strength, pain, functionality, and quality of life.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
June 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Özlem Feyzioğlu

Asistant Professor

Acibadem University

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with breast cancer, undergoing breast-conserving surgery or having a total mastectomy and undergoing axillary lymph node dissection during surgery
  • Cases that will start radiotherapy after surgery
  • Being over 18 years old
  • Absence of limitation in shoulder joint range of motion in preoperative evaluations.
  • No speech and hearing problems
  • Volunteering of the patients included in the study

Exclusion Criteria

  • Having previously undergone ipsilateral or contralateral breast cancer surgery
  • Presence of active or metastatic cancer focus
  • Presence of a neurological disease or orthopedic surgery affecting upper extremity functionality
  • Carrying a pacemaker
  • Presence of infection and open wound
  • Finding a post-surgical drain
  • Cases with mental and cooperation problems

Outcomes

Primary Outcomes

Muscle strength

Time Frame: 6 weeks

Hand-held dynamometer will be used to evaluate shoulder flexion, abduction, external and internal rotation muscles' strength

Range of motion

Time Frame: 6 weeks

Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.

Secondary Outcomes

  • Pain - Visual Analogue Scale(6 weeks)
  • Tone - Myoton® PRO(6 weeks)
  • Stiffness of Muscle- Myoton® PRO(6 weeks)
  • Grip strength(6 weeks)
  • Disability(6 weeks)
  • Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)(6 weeks)
  • Elasticity of Muscle -Myoton® PRO(6 weeks)

Study Sites (1)

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