Effects of Core-Focused Exercise Training and Kinesiology Taping Combined With Complex Decongestive Physiotherapy on Posture, Pain, Function, and Quality of Life in Women With Breast Cancer-Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Mean of cervical, thoracic, and lumbar pain intensity scores
研究概览
简要总结
The aim of the present study is to investigate the effects of trunk- focused exercise training and kinesiology taping, in addition to standard lymphedema treatment (complex decongestive therapy-CDT) on posture, pain, functionality and quality of life in women with breast cancer related lymphedema. This study is designed as a randomized placebo-controlled trial.
Lymphedema negatively affects the musculoskeletal system, leading to shoulder girdle muscle imbalances, cervical and thoracolumbar pain, scapular dysfunction and spinal postural alterations. Although CDT is considered the gold standard for edema management, its effects have primarily been evaluated in terms of edema reduction and symptom control, and there is limited evidence regarding its impact on posture, musculoskeletal symptoms, and quality of life, as well as the potential effects of prolonged compression bandaging applied during the intensive phase on these systems.
Trunk-focused exercise training is expected to improve spinal stability, mobility and postural control, while kinesiology taping may help alleviate musculoskeletal symptoms by providing proprioceptive input and mechanical support. By combining these interventions, this study aims to provide a comprehensive rehabilitation approach targeting both physical and functional impairments. If additional improvements in posture, pain, function, and quality of life are observed compared to a control group receiving CDT combined with lower extremity exercise and placebo taping, these findings will support the added value of a multimodal rehabilitation approach beyond standard care.
The findings of this randomized placebo-controlled trial are expected to contribute to the literature by providing evidence for a comprehensive and holistic treatment approach in breast cancer-related lymphedema and to support the integration of trunk-focused exercise training and kinesiology taping into routine clinical practice. To the best of our knowledge, there is currently no randomized placebo-controlled study investigating the effects of trunk-focused exercise training and kinesiology taping in addition to CDT on posture, pain, functionality, and quality of life.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 65 years
- •Diagnosis of stage 1-2 lymphedema according to the International Society of Lymphology classification system
- •History of radical surgery due to primary breast cancer, with at least 6 months elapsed since surgery
- •Completion of cancer treatments such as chemotherapy and / or radiotherapy
- •Presence of pain with a score of ≥3 on the Numeric Rating Scale (NRS) in at least one of the lumbar, thoracic, or cervical regions
- •No cooperation problems in completing the study questionnaires
排除标准
- •Body mass index (BMI) >30 kg/m²
- •Presence of active infection
- •Presence of active malignancy or metastasis
- •Presence of neurological disease
- •History of bilateral breast cancer
- •Presence of extremity deformity, scoliosis, cauda equina syndrome, or history of whiplash injury
- •Presence of motor or sensory neurological deficits (to be clinically assessed by manual muscle testing and superficial sensory examination)
- •History of spinal surgery
- •Presence of any spinal pathology
研究组 & 干预措施
Complex decongestive therapy, trunk-focused exercise and kinesiology taping
Trunk-focused exercise and kinesiology taping
干预措施: Complex Decongestive Therapy (Other)
Complex decongestive therapy, trunk-focused exercise and kinesiology taping
Trunk-focused exercise and kinesiology taping
干预措施: Trunk Focused exercises (Other)
Complex decongestive therapy, trunk-focused exercise and kinesiology taping
Trunk-focused exercise and kinesiology taping
干预措施: Kinesiology taping (Other)
Complex decongestive therapy, plasebo taping and lower extremity exercises
Lower extremity exercises and plasebo taping
干预措施: Complex Decongestive Therapy (Other)
Complex decongestive therapy, plasebo taping and lower extremity exercises
Lower extremity exercises and plasebo taping
干预措施: Lower extremity exercises (Other)
Complex decongestive therapy, plasebo taping and lower extremity exercises
Lower extremity exercises and plasebo taping
干预措施: Placebo taping (Other)
结局指标
主要结局
Mean of cervical, thoracic, and lumbar pain intensity scores
时间窗: Change in mean cervical, thoracic, and lumbar pain intensity scores from baseline to the end of the third week.
Pain intensity in the cervical, thoracic, and lumbar regions will be assessed using the Numeric Rating Scale (NRS), and the mean of these scores will be calculated; participants will rate their pain from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Thoracic kyphosis angle(Change in thoracic kyphosis angle from baseline to the end of the third week.)
- Lumbar lordosis angle(Change in lumbar lordosis angle from baseline to the end of the third week.)
- Pain pressure threshold(Change in pain pressure threshold from baseline to the end of the third week.)
- Patient assessment of Postural Awareness(Change in postural awareness from baseline to the end of the third week.)
- Upper extremity functionality(Change in upper extremity functionality from baseline to the end of the third week.)
- Upper Limb Functionality(Change in functionality from baseline to the end of the third week.)
- Patient assessment of Quality of life(Change in quality of life from baseline to the end of the third week.)
研究者
SERAP ÖZGÜL
Prof.Dr
Hacettepe University