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

NCT05680116 | Completed

• 1 other identifier: ATADEK 2022-17/27
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Muscle strength

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

  6 weeks

• Range of motion

  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.

  6 weeks

Secondary Outcomes (7)

• Pain - Visual Analogue Scale

  6 weeks

• Grip strength

  6 weeks

• Disability

  6 weeks

• Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)

  6 weeks

• Tone - Myoton® PRO

  6 weeks

Study Arms (2)

Home based exercise group

ACTIVE COMPARATOR

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.

Other: Home based exercise

Home based exercise plus vibration therapy group.

EXPERIMENTAL

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.

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

Interventions

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

Patients will wear Myovolt shoulder device twice a week and each session will continue 30minutes. This therapy will apply during the radiotherapy process. The device will be applied on the bare skin of the shoulder area. The first 10 minutes of the 30 minutes will be intermittent vibration, the other 20 minutes will be done in the sinusoidal vibration program. Both programs will be in the range of 20-100 Hz.

Home based exercise plus vibration therapy group.

Home based exercise OTHER

Patients will do home based exercise during the radiotherapy process. 5 days a week. 2 sessions a day, each exercise will be 10x2 repetitions

Home based exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Professor Cemil Taşcıoğlu Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Feyzioglu O, Dincer S, Yilmaz BD, Saldiran TC, Ozturk O. Effects of Vibration Therapy on Muscle Strength, Shoulder Range of Motion, and Muscle Biomechanical Properties in Patients With Breast Cancer Undergoing Radiotherapy: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):325-334. doi: 10.1097/PHM.0000000000002664. Epub 2024 Nov 14.

  PMID: 39774038 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Özlem Feyzioğlu, PhD

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 11, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 15, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

TU (1)