Investigation of the Effectiveness of Physiotherapy After Breast Reduction Surgery.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Breast-Q Reduction Module Score
研究概览
简要总结
Background and Purpose:
Breast reduction surgery is a major procedure that can lead to post-operative pain, postural deviations, and a temporary decline in quality of life.This clinical study aims to investigate the efficacy of early-phase physical therapy on pain management, postural alignment, and overall quality of life in female patients following breast reduction surgery.
Study Design and Participants:
This is a controlled clinical trial involving 40 female participants aged 18 to 50 who have undergone their first breast reduction surgery. Participants are divided into two groups: an intervention group (n=20) and a control group (n=20). The study follows a pre-test and post-test design to evaluate outcomes before and after a three-week intervention period.
Intervention Protocol:
The intervention group receives a comprehensive physical therapy program starting one week post-operation. The program is conducted three days a week for three weeks, with sessions lasting 40 to 60 minutes The protocol includes:
Postural and cervical exercises Scapular stabilization and manual therapy Scar massage and Transcutaneous Electrical Nerve Stimulation (TENS) as needed A structured home exercise program.
Outcome Measures:
Primary and secondary outcomes are assessed through various clinical tools:
Pain:Visual Analog Scale (VAS) Posture: New York Posture Test, measurements of scapular protraction and cervical anterior tilt Mobility:Shoulder and cervical Range of Motion (ROM) Quality of Life and Health: SF-12, BREAST-Q, and Pittsburgh Sleep Quality Index (PSQI)
Expected Results:
The study anticipates that the early-phase physical therapy group will demonstrate a significant reduction in pain, improved postural alignment, and a higher quality of life compared to the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being between 18 and 50 years of age
- •Having undergone aesthetic breast reduction surgery
- •Having a complication-free postoperative period
- •Agreeing to participate in the study voluntarily and having signed the informed consent form
排除标准
- •Oncological History:
- •Those who have been diagnosed with breast cancer in the pre-operative or per-operative period, or those with a history of radiotherapy/chemotherapy to the breast area,
- •Lymphovenous Disorders: Those with lymphedema in the upper extremity or vascular insufficiency that may severely affect lymphatic drainage,
- •Musculoskeletal and Nervous System Pathologies: Those with orthopedic diseases such as severe scoliosis, ankylosing spondylitis, or neurological diseases such as brachial plexus lesions that may affect posture analysis and shoulder mobility,
- •Systemic Diseases: Those with uncontrolled Diabetes Mellitus, which directly negatively affects wound healing, or those with active autoimmune connective tissue diseases,
- •Exercise Contraindications: Patients with cardiopulmonary failure or severe cognitive impairment that would prevent participation in the physiotherapy protocol.
结局指标
主要结局
Breast-Q Reduction Module Score
时间窗: Baseline (preoperative) and 4 weeks after treatment
Breast-related satisfaction will be assessed using the BREAST-Q Reduction Module.
次要结局
- Posture Evaluation(Baseline and 4 weeks after treatment)
- Pain Intensity (VAS)(Baseline (preoperative) and 4 weeks after treatment)
- Quality of Life (SF-12)(Baseline and 4 weeks after treatment)
- Pittsburgh Sleep Quality Index Total Score(Baseline and 4 weeks after treatment)
研究者
Ozden Baskan
Assistant Professor
Istanbul Rumeli University