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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680116
• Other study ID #: ATADEK 2022-17/27
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: December 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 15, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
Turkey	Professor Cemil Tascioglu Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Hand-held dynamometer will be used to evaluate shoulder flexion, abduction, external and internal rotation muscles' strength	6 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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