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

Breast Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05386628
• Other study ID #: 2022/0132
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2022
• Source: Istanbul Medeniyet University
• Contact: Nilüfer Kablan, PhD
• Phone: +905067638556
• Email: niluferkablan[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 15, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

Other:
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	measurement of skin temperature	measurements will be taken from the area covering 3 cm of the surgical incision with a P45 thermographic camera with high thermal sensitivity (Flir Sistem, ThermaCAM, Sweden).	changes from baseline skin temperature values will be measured at 6 week and 10 week
Secondary	measurement of pain	Pain will be evaluated by visual analog scale (VAS). In the scale, the patient is asked to mark the most appropriate pain intensity on a scale ranging from 0 (no pain) to 10 (tolerable pain). The higher the score, the greater the pain intensity.	changes from baseline pain values will be measured at 6 week and 10 week
Secondary	measurement of pain pressure threshold	Pain pressure threshold will be evaluated by a digital algometer (Algometer Commander, Jtech Medical, MM036_K, 2016).	changes from baseline pain pressure threshold values will be measured at 6 week and 10 week
Secondary	measurement of grip strength	The grip strength of both hand will be evaluated by "hand-held" dynamometer.	changes from baseline grip strength values will be measured at 6 week and 10 week