The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors
1 other identifier
interventional
48
1 country
1
Brief Summary
In breast cancer patients, limitation of shoulder joint movement occurs following mastectomy surgery. Studies have reported that damage to the fascia on the pectoralis major muscle during mastectomy surgery contributes to the development of the limitation. The aim of this study is to investigate the effect of release techniques applied to the fascia on the pectoralis major muscle and the fascial chain on the incerasing of shoulder joint range of motion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedJuly 15, 2024
July 1, 2024
2.8 years
May 18, 2022
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain .
changes from baseline stiffness values will be measured at 6 week and 10 week
measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
changes from baseline tone values will be measured at 6 week and 10 week
measurement of creep of tissue
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
changes from baseline creep values will be measured at 6 week and 10 week
measurement of the range of shoulder joint motion
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
changes from baseline range of the shoulder joint motion values will be measured at 6 week and 10 week
assessment of activity of daily living
upper extremity daily living functional capacity of participation will be assessed with the Quick-DASH (Shortened Disabilities Arm, Shoulder and Hand Questionnaire). The scale consists of 11 items. In the scale, a 5-point Likert scale is evaluated and scored 1-5. The scores that can be obtained from the scale are between 0-100. Lower scores indicate better daily activity participation.
changes from baseline Quick-DASH Questionnaire scores will be assessment at 6 week and 10 week
assessment of depression and anxiety
quality of life will be assessed using the Hospital Anxiety and Depression Scale (HAD). The scale consists of 14 items (7 items depression and 7 items anxiety). The scale is evaluated on a 4-point Likert scale and is scored 0-3. Depression and anxiety scores are calculated separately. While the score range that can be taken in the lower scales is 0-21, low scores are considered positive.
changes from baseline HAD scale scores will be assessment at 6 week and 10 week
Secondary Outcomes (4)
measurement of skin temperature
changes from baseline skin temperature values will be measured at 6 week and 10 week
measurement of pain
changes from baseline pain values will be measured at 6 week and 10 week
measurement of pain pressure threshold
changes from baseline pain pressure threshold values will be measured at 6 week and 10 week
measurement of grip strength
changes from baseline grip strength values will be measured at 6 week and 10 week
Study Arms (4)
control group
ACTIVE COMPARATORConventional physiotherapy program (joint movement exercises, local relaxation techniques, etc.) will be applied to the participants in this group.
Manual lymphatic drainage group
EXPERIMENTALIn addition to the conventional physiotherapy program, manual lymphatic drainage (including upper limb extremity and anterior/posterior axillar-axillar anastomoses and axilla-inguinal anastomosis) will be applied to the participants in this group.
Myofascial relasing group
EXPERIMENTALIn addition to the conventional physiotherapy program, myofascial chain relasing techniques will be applied to the participants in this group.
Lymphatic drainage and myofascial releasing group
EXPERIMENTALIn addition to the conventional physiotherapy program, manual lymphatic drainage (including upper limb extremity and anterior/posterior axillar-axillar anastomoses and axilla-inguinal anastomosis) and myofascial chain relasing techniques will be applied to the participants in this group.
Interventions
A basic physiotherapy program consisting of shoulder exercises will be applied to the participants. content of the physiotherapy program * Shoulder passive/active abduction, flexion, internal and external rotation exercises * Posture exercises * Neck stretching exercises * Pectoralis major stretching exercises * Shoulder capsule stretching exercises * Scapular Mobilization exercises
manual lymph drainage is a manual technique that is applied to the lymphatic system with a pressure of 40-50 mmHg and increases the working speed of lymphatic nodules/collectors. Manual lymph drainage will be made to the anterior axillar-axillar, posterior axillar-axillar and axilla-inguinal anastomosis collectors and the arm region (up to the elbow) lymph collectors.
it will be done with the thumb or 3rd finger from the acu points of the superficial arm-anterior myofascial chain. 6-8 seconds with thumb to these points. pressure will be applied and vibration will be given clockwise.
Eligibility Criteria
You may qualify if:
- Women between the ages of 30-60
- Having breast surgery within 2 years
- Not have received conservative treatment for shoulder rehabilitation in the last 6 months
- Having limitation of movement of the shoulder joint due to breast surgery
You may not qualify if:
- Not having agreed to participate in the study
- Having undergone radical mastectomy surgery
- Having connective tissue disease
- Presence of brachial plexus paresis/plegia
- Presence of radiogenic fibrosis
- Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions
- Presence of active metastases
- Having undergone reconstruction surgery
- Continuation of radiotherapy (must have ended at least 3 months ago) or chemotherapy applications
- Having had a bilateral mastectomy
- To develop lymphedema in the arm-trunk
- Use of muscle relaxants
- Patients with severe chemotherapy side effects (hyperesthesia, nausea, skin changes, weakness, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İstanbul Medeniyet University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
May 18, 2022
First Posted
May 23, 2022
Study Start
August 15, 2022
Primary Completion
June 15, 2025
Study Completion
July 15, 2025
Last Updated
July 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share