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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

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

Home based exercise

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Professor Cemil Taşcıoğlu Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Home based exercise group

Home based exercise plus vibration therapy group.

Arm 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.

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.

Outcomes

Primary Outcome Measures

Muscle strength

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

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.

Secondary Outcome Measures

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.

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)

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

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

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.

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

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;

Full Information

NCT ID

NCT05680116

First Posted

December 25, 2022

Last Updated

September 15, 2023

Sponsor

Acibadem University

1. Study Identification

Unique Protocol Identification Number

NCT05680116

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

June 1, 2023 (Actual)

Study Completion Date

June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home based exercise group

Arm Type

Active Comparator

Arm 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.

Arm Title

Home based exercise plus vibration therapy group.

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Home based exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Muscle strength

Description

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

Time Frame

6 weeks

Title

Range of motion

Description

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.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Pain - Visual Analogue Scale

Description

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.

Time Frame

6 weeks

Title

Grip strength

Description

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)

Time Frame

6 weeks

Title

Disability

Description

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

Time Frame

6 weeks

Title

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

Description

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

Time Frame

6 weeks

Title

Tone - Myoton® PRO

Description

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.

Time Frame

6 weeks

Title

Stiffness of Muscle- Myoton® PRO

Description

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

Time Frame

6 weeks

Title

Elasticity of Muscle -Myoton® PRO

Description

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;

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Özlem Feyzioğlu, PhD

Organizational Affiliation

Acibadem University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Professor Cemil Taşcıoğlu Training and Research Hospital

City

Istanbul

Country

Turkey

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial