跳至主要内容
临床试验/NCT05386628
NCT05386628已完成不适用

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

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
assessment of activity of daily living

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.)

研究组 & 干预措施

control group

Active Comparator

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

干预措施: conventional physiotherapy (Other)

Manual lymphatic drainage group

Experimental

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.

干预措施: conventional physiotherapy (Other)

Manual lymphatic drainage group

Experimental

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.

干预措施: Manual lymphatic drainage (Other)

Myofascial relasing group

Experimental

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

干预措施: conventional physiotherapy (Other)

Myofascial relasing group

Experimental

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

干预措施: Myofascial relasing (Other)

Lymphatic drainage and myofascial releasing group

Experimental

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.

干预措施: conventional physiotherapy (Other)

Lymphatic drainage and myofascial releasing group

Experimental

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.

干预措施: Manual lymphatic drainage (Other)

Lymphatic drainage and myofascial releasing group

Experimental

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.

干预措施: Myofascial relasing (Other)

结局指标

主要结局

assessment of activity of daily living

时间窗: changes from baseline Quick-DASH Questionnaire scores will be assessment at 6 week and 10 week

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.

assessment of depression and anxiety

时间窗: changes from baseline HAD scale scores will be assessment at 6 week and 10 week

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.

measurement of passive muscle tone (Hz)

时间窗: changes from baseline tone values will be measured at 6 week and 10 week

muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain

measurement of creep of tissue

时间窗: changes from baseline creep values will be measured at 6 week and 10 week

creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain

measurement of the range of shoulder joint motion

时间窗: changes from baseline range of the shoulder joint motion values will be measured at 6 week and 10 week

The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.

measurement of tissue stiffness (N/m)

时间窗: changes from baseline stiffness values will be measured at 6 week and 10 week

Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain .

次要结局

  • measurement of grip strength(changes from baseline grip strength 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 pain(changes from baseline pain values will be measured at 6 week and 10 week)
  • measurement of skin temperature(changes from baseline skin temperature values will be measured at 6 week and 10 week)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilufer Kablan

Head of Department

Istanbul Medeniyet University

研究点 (1)

Loading locations...

相似试验

The Effect of Myofascial Chain Release Techniques on... | 临床试验