- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764394
The Effect of Myofascial Release Exercises on Viscoelastic Changes of the Pectoralis Major Muscle, Pain, Range of Motion and Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery
The Effect of Myofascial Release Exercises on Viscoelastic Changes of the Pectoralis Major Muscle
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- SBU. Prof. Dr. Cemil Taşçıoğlu City Hospital- Oncology Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- -Stage I-II-III defined by radiation oncologists after breast cancer surgery and who will start radiotherapy
- Breast conserving surgery or total mastectomy with axillary lymph node dissection during surgery
- No neurological or orthopaedic problems that may limit the range of motion of the shoulder joint in the preoperative evaluations,
- Individuals who volunteer to participate in the study will be included.
Exclusion Criteria:
- Previous breast clamp surgery on the same side or contralateral side,
- With a metastatic cancer focus,
- Post-surgical resistance, infection and open wound, pacemaker,
- Patients with a Mini Mental State Examination test score of less than 21 will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: home based exercise group
home-based exercise 5 days a week
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home based exercise 5 days/week
Other Names:
home based exercise plus myofacial release exercise Myofascial release exercises will continue for 6 weeks, 2 sessions per week and each session will continue for 30 minutes.All evaluations will be performed at the beginning of radiotherapy treatment and at the end of the 6th week.
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Experimental: Myofascial release exercise group
home based exercise plus Myofascial release exercise
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home based exercise 5 days/week
Other Names:
home based exercise plus myofacial release exercise Myofascial release exercises will continue for 6 weeks, 2 sessions per week and each session will continue for 30 minutes.All evaluations will be performed at the beginning of radiotherapy treatment and at the end of the 6th week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Range of motion
Time Frame: 6 weeks
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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.
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6 weeks
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Tone - pectoralis major
Time Frame: 6 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)
Time Frame: 6 weeks
|
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
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6 weeks
|
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Pain - Visual Analogue Scale
Time Frame: 6 weeks
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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
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6 weeks
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Shoulder Pain and Disability Index- SPADI
Time Frame: 6 weeks
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Shoulder Pain and Disability Index: The Shoulder Pain and Disability Index (SPADI) is used to assess the pain and disability of individuals during certain activities.
The SPADI is an assessment method consisting of two sub-headings, pain and functional status, which are completed in approximately 5-10 minutes.
The first part consists of 5 questions to assess the level of pain during lying down, lying on the affected side and pushing activities.
The second part consisting of 8 questions evaluates the functional status by questioning dressing, personal care and carrying activities.
The subjects answer each question using a 10 cm Visual Analogue Scale.
The answers to the questions are calculated as percentiles.
The total score varies between 0-130, with the higher percentile indicating increased disability.
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6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATADEK 2024-19/733
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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