Clinical trial NCT05386628: The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors
Official title: The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion Following Mastectomy Surgery in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivors
Keywords: breast cancer
range of motion
lymphatic drainage
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: measurement of tissue stiffness (N/m)
timeFrame: changes from baseline stiffness values will be measured at 6 week and 10 week
measure: measurement of passive muscle tone (Hz)
timeFrame: changes from baseline tone values will be measured at 6 week and 10 week
measure: measurement of creep of tissue
timeFrame: changes from baseline creep values will be measured at 6 week and 10 week
measure: measurement of the range of shoulder joint motion
timeFrame: changes from baseline range of the shoulder joint motion values will be measured at 6 week and 10 week
measure: assessment of activity of daily living
timeFrame: changes from baseline Quick-DASH Questionnaire scores will be assessment at 6 week and 10 week
measure: assessment of depression and anxiety
timeFrame: changes from baseline HAD scale scores will be assessment at 6 week and 10 week
Secondary outcomes:
measure: measurement of skin temperature
timeFrame: changes from baseline skin temperature values will be measured at 6 week and 10 week
measure: measurement of pain
timeFrame: changes from baseline pain values will be measured at 6 week and 10 week
measure: measurement of pain pressure threshold
timeFrame: changes from baseline pain pressure threshold values will be measured at 6 week and 10 week
measure: measurement of grip strength
timeFrame: changes from baseline grip strength values will be measured at 6 week and 10 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References: