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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MYOVOLT (MyovoltTM, Myovolt Limited, Christchurch, New Zealand ) wearable vibration therapy device
* Other: Home based exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home based exercise group<br>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<br>* Patients will do home based exercise during the radiotherapy process. 5 days a week. 2 sessions a day, each exercise will be 10x2 repetitions<br>|
| Experimental: Home based exercise plus vibration therapy group.<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - Visual Analogue Scale | Visual Analogue Scale is one of the simple and common methods used in pain assessment. Self reported pain intensity during the rest and the activity measured by 0-10 centimeter chart. Visual Analogue Scale (VAS), where 0 indicates no pain or best and 10 indicates the most intense pain imaginable or worst. The patient will mark the severity of the pain on a 10 cm long chart. | 6 weeks | 
| Grip strength | Grip strength was evaluated by hand grip dynamometry (Saehan Hydraulic Hand Dynamometer ) Measurements were performed in affected side according to positions defined by American Society of Hand Therapists (sitting with the shoulder adducted to the side and the elbow flexed 90° with the forearm and wrist in the neutral mid-position) | 6 weeks | 
| Disability | Disabilities of the Arm Shoulder and Hand ( DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.The DASH questionnaire consists of three parts.The first part consists of 30 questions. 21 questions assess the difficulty of the patient in daily life activities, 5 question symptoms, and the remaining 4 questions assess social function, work, sleep, and self-confidence of the patient.In the DASH questionnaire, questions are answered in 5-point likert system. 1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all. The total score varies between 0 and 100 points and the low score indicates good health | 6 weeks | 
| Quality of Life- Functional Assessment of Cancer Therapy-Breast (FACT-B) | It is designed to evaluate the quality of life in breast cancer patients from multiple perspectives. Its validity and reliability have been demonstrated. It consists of 5 subscales that assess quality of life as physical condition (7 questions), social life and family status (7 questions), emotional status (6 questions), activity status (7 questions), and other breast cancer-specific concerns (9 questions). The survey has 5-point likert scoring (0=not at all, 1=a little, 2=a little, 3=quite a lot, 4=a lot) . The total score is calculated by summing the subscale scores. A higher score on the questionnaire indicates a higher quality of life | 6 weeks | 
| Tone - Myoton® PRO | Myoton® PRO (Myoton Ltd, Myoton AS, Estonia) device will be used to objectively evaluate the measurement of Pectoralis Major muscle tone of the patients who will participate in the study. Myoton® PRO is a portable digital device that measures the tone with an objective and noninvasive method. A constant pre-pressure (0.18 N) is applied to the skin surface to compress the subcutaneous superficial tissues. The tension state of the tissue that characterized by the natural oscillation frequency; Hz. | 6 weeks | 
| Stiffness of Muscle- Myoton® PRO | Myoton® PRO (Myoton Ltd, Myoton AS, Estonia) device will be used to objectively evaluate the measurement of Pectoralis Major muscle stiffness of the patients who will participate in the study. Myoton® PRO is a portable digital device that measures the stiffness with an objective and noninvasive method. A constant pre-pressure (0.18 N) is applied to the skin surface to compress the subcutaneous superficial tissues. The stiffness of the tissue that characterized by the natural oscillation stiffness; N/m | 6 weeks | 
| Elasticity of Muscle -Myoton® PRO | Myoton® PRO (Myoton Ltd, Myoton AS, Estonia) device will be used to objectively evaluate the measurement of Pectoralis Major muscle elasticity of the patients who will participate in the study. Myoton® PRO is a portable digital device that measures the elasticity with an objective and noninvasive method. A constant pre-pressure (0.18 N) is applied to the skin surface to compress the subcutaneous superficial tissues. The elasticity of the tissue that characterized bythe logarithmic decrease of the natural oscillation; | 6 weeks |