The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors

NCT ID: NCT05386628

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2025-07-15

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.

Detailed Description

After mastectomy, complications such as decreased range of motion and muscle strength in the shoulder joint, development of pain and tenderness, and formation of lymphedema are frequently observed. In addition to causing a significant decrease in the patient's daily life quality, shoulder limitation also negatively affects the treatment process by preventing the joint position required for radiotherapy. For this reason, it is a priority to prevent the development of shoulder joint limitations that may occur following surgery and to open the developing limitation immediately. This study was born from the idea that the relaxation techniques to be applied to regain the mobility of the fascial structure, which has been damaged and whose mobility has decreased due to breast surgery, should be performed by covering the entire myofascial chain. In addition, the investigators aim to prevent adhesions that will limit the mobility of soft tissue by minimizing scar tissue formation with early drainage of postoperative edema. The aim of this study is to investigate the effectiveness of myofascial chain relaxation techniques and manual lymphatic drainage applied to improve soft tissue mobility in the prevention and elimination of shoulder limitations after breast cancer surgery.

A total of 48 patients who agreed to participate in the study will be enrolled in the treatment program twice a week for 6 weeks. During the study, the same assessments will be applied to all patients and the cases will be evaluated 3 times (pre-treatment, post treatment, and one month post treatment). During the assessments, the physical evaluations of the patients on the shoulder region will be examined in detail using objective and subjective methods.

Conditions

Breast Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

Conventional physiotherapy program (joint movement exercises, local relaxation techniques, etc.) will be applied to the participants in this group.

Group Type: ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type: OTHER

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 lymphatic drainage group

In 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.

Group Type: EXPERIMENTAL

conventional physiotherapy

Intervention Type: OTHER

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 lymphatic drainage

Intervention Type: OTHER

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.

Myofascial relasing group

In addition to the conventional physiotherapy program, myofascial chain relasing techniques will be applied to the participants in this group.

Group Type: EXPERIMENTAL

conventional physiotherapy

Intervention Type: OTHER

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

Myofascial relasing

Intervention Type: OTHER

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.

Lymphatic drainage and myofascial releasing group

In 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.

Group Type: EXPERIMENTAL

conventional physiotherapy

Intervention Type: OTHER

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 lymphatic drainage

Intervention Type: OTHER

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.

Myofascial relasing

Intervention Type: OTHER

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.

Interventions

conventional physiotherapy

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

Intervention Type: OTHER

Manual lymphatic drainage

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.

Intervention Type: OTHER

Myofascial relasing

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Nilufer Kablan

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstanbul Medeniyet University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nilüfer Kablan, PhD

Role: CONTACT

niluferkablan@yahoo.com

+905067638556

Gülser Cinbaz, MSc

Role: CONTACT

gulser.cinbaz@gmail.com

+905558503576

Facility Contacts

Gülser Cinbaz

Role: primary

gulser.cinbaz@gmail.com

+905558502576

Study Documents

Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Document Type: Individual Participant Data Set

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Other Identifiers

2022/0132

Identifier Type: -

Identifier Source: org_study_id