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

Acibadem University

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Home based exercise; Device: MYOVOLT (MyovoltTM, Myovolt Limited, Christchurch, New Zealand ) wearable vibration therapy device

Study type: Interventional

Funder types: Other

Identifiers

NCT05680116

ATADEK 2022-17/27

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 2 patient groups

Home based exercise group

Active Comparator group

Description:

Patients who will start radiotherapy after breast cancer surgery will be evaluated prior to treatment. During the radiotherapy process, all of the patients will be included in the home exercise program, 5 days a week, 2 sessions a day, each exercise will be 10x2 repetitions. Exercise follow-up of the patients will be provided with weekly routine face-to-face checks. After an average of 6 weeks of radiotherapy, the initial evaluations will be repeated.

Treatment:

Other: Home based exercise

Home based exercise plus vibration therapy group.

Experimental group

Description:

Patients who will start radiotherapy after breast cancer surgery will be evaluated prior to treatment. During the radiotherapy process, all of the patients will be included in the home exercise program, 5 days a week, 2 sessions a day, each exercise will be 10x2 repetitions. The study group continues their home based exercise, in addition they will receive 30 minutes of Myovolt (Myovolt TM, Myovolt Limited, Christchurch, New Zealand) device which is wearable vibration therapy 2 days a week. The vibration program will continue for 6 weeks, in the form of 2 sessions per week. Intermittent and sinusoidal modes between 20-100 Hz will be used for the vibration frequency.

Treatment:

Device: MYOVOLT (MyovoltTM, Myovolt Limited, Christchurch, New Zealand ) wearable vibration therapy device