Effects of Scapulothoracic Stabilization and Postural Training Added to Standard Lymphedema Care on Muscle Strength, Posture and Functional Outcomes in Secondary Upper Extremity Lymphedema: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Shoulder Height Asymmetry
研究概览
简要总结
This single-center randomized controlled trial aims to investigate the effects of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly assigned to receive either standard lymphedema care alone or standard care combined with scapulothoracic stabilization and postural training. Outcomes including scapular muscle strength, posture, upper extremity function, limb volume, and neck awareness will be assessed at baseline, immediately after treatment, and at a 2-month follow-up. The findings are expected to provide evidence regarding the effectiveness of incorporating targeted stabilization and postural exercises into conventional lymphedema rehabilitation.
详细描述
Secondary upper extremity lymphedema is a common complication following breast cancer treatment and is characterized by chronic swelling, pain, reduced muscle strength, impaired upper extremity function, and postural alterations. These impairments may negatively affect daily activities, body perception, and quality of life. Although Complex Decongestive Therapy (CDT) is considered the gold standard for lymphedema management, conventional treatment primarily focuses on edema reduction and does not specifically address scapular stability, postural alignment, or neuromuscular control.
Altered scapulothoracic biomechanics and postural dysfunction are frequently observed in individuals with breast cancer-related lymphedema. These impairments may contribute to shoulder dysfunction, muscle weakness, compensatory movement patterns, and persistent functional limitations. Scapulothoracic stabilization exercises aim to restore scapular muscle balance and improve dynamic shoulder stability, whereas postural training promotes optimal alignment and body awareness. The combined application of these interventions may enhance functional recovery beyond the effects of standard CDT alone; however, evidence from randomized controlled trials remains limited.
This single-center, prospective, randomized controlled trial aims to evaluate the effectiveness of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly allocated to either a control group receiving standard lymphedema care or an intervention group receiving standard care plus scapulothoracic stabilization and postural training. Randomization will be performed using a computer-generated allocation sequence, and all outcome assessments will be conducted by a blinded assessor.
Outcome measures will be collected at baseline, immediately after completion of treatment, and at a 2-month follow-up. Primary and secondary outcomes will include scapular muscle strength measured with a handheld dynamometer (MicroFET2), postural alignment assessed using the PostureScreen application, upper extremity function evaluated with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, limb volume calculated from serial circumference measurements, and neck awareness assessed using the Fremantle Neck Awareness Questionnaire (FreNAQ). The findings of this study are expected to provide evidence regarding the clinical benefits of incorporating targeted scapulothoracic stabilization and postural training into conventional lymphedema rehabilitation and may contribute to the development of more comprehensive rehabilitation protocols for breast cancer survivors.
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)
盲法说明
Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded. However, all outcome assessments will be performed by an independent assessor who is blinded to treatment allocation. Participants will be instructed not to disclose their group assignment during assessments, and statistical analyses will be conducted using coded group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 65 years.
- •Diagnosed with secondary upper extremity lymphedema following breast cancer surgery (mastectomy).
- •Willing to participate in the study.
- •Able to provide written informed consent.
排除标准
- •Active infection (e.g., cellulitis or lymphangitis).
- •Advanced shoulder or cervical pathology.
- •Neurological disorders affecting upper extremity function.
- •Metastatic disease.
- •Receiving active chemotherapy.
- •Participation in another intensive lymphedema rehabilitation program within the previous 3 months.
研究组 & 干预措施
Scapulothoracic Stabilization
Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program. The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function. Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
干预措施: Complex Decongestive Therapy (Procedure)
Scapulothoracic Stabilization
Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program. The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function. Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
干预措施: Scapulothoracic Stabilization and Postural Training (Behavioral)
Control
Participants assigned to the control group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises according to routine clinical practice. Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
干预措施: Complex Decongestive Therapy (Procedure)
结局指标
主要结局
Change in Shoulder Height Asymmetry
时间窗: Baseline, immediately after completion of treatment, and 2 months after treatment.
Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
Change in Shoulder Anterior Translation
时间窗: Baseline, immediately after completion of treatment, and 2 months after treatment.
Shoulder anterior translation will be assessed using the PostureScreen mobile application.
Change in Upper Extremity Function
时间窗: Baseline, immediately after completion of treatment, and 2 months after treatment
Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The DASH is a validated 30-item patient-reported outcome measure evaluating symptoms and functional limitations of the upper extremity. Scores range from 0 to 100, with higher scores indicating greater disability.
Change in Head Anterior Translation
时间窗: Baseline, immediately after completion of treatment, and 2 months after treatment
Head anterior translation will be assessed using the PostureScreen mobile application.
次要结局
- Change in Scapular Muscle Strength(Baseline, immediately after completion of treatment, and 2 months after treatment)
研究者
Idil Esin Unlu
Asst. Prof.
Toros University
