Breast Cancer Related Lymphedema
Conditions
Brief summary
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.
Interventions
Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.
OTHERTrunk Focused exercises
Postural and spinal stabilization exercises will be performed three times per week in supine, side-lying, quadruped, sitting, and standing positions, with 8-10 repetitions for each exercise.
OTHERKinesiology taping
Kinesiology taping will be applied bilaterally to the scalene, trapezius, and paraspinal muscles using a muscle facilitation technique twice per week.
OTHERLower extremity exercises
Lower extremity range of motion exercises will be performed three times per week, with 8-10 repetitions for each exercise.
OTHERPlacebo taping
Placebo kinesiology taping without tension will be applied to the cervical, thoracic, and lumbar regions twice per week.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of cervical, thoracic, and lumbar pain intensity scores | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thoracic kyphosis angle | Change in thoracic kyphosis angle from baseline to the end of the third week. | Thoracic kyphosis and lumbar lordosis will be assessed using a flexicurve device. With the participant in a relaxed standing posture, the assessor will identify and mark the C7-T12 and L1-S2 spinous processes by palpation. The flexicurve will then be molded along the spine and its contour transferred onto paper. The flexicurve index and kyphosis angle will then be calculated using standard geometric and trigonometric formulas |
| Lumbar lordosis angle | Change in lumbar lordosis angle from baseline to the end of the third week. | Thoracic kyphosis and lumbar lordosis will be assessed using a flexicurve device. With the participant in a relaxed standing posture, the assessor will identify and mark the C7-T12 and L1-S2 spinous processes by palpation. The flexicurve will then be molded along the spine and its contour transferred onto paper. The flexicurve index and kyphosis angle will then be calculated using standard geometric and trigonometric formulas |
| Pain pressure threshold | Change in pain pressure threshold from baseline to the end of the third week. | Pain pressure threshold will be assessed using an algometer. Measurements will be taken three times from the midpoint of the upper trapezius, thoracic, and lumbar paraspinal muscles with participants in a seated position, and the mean value will be recorded. |
| Patient assessment of Postural Awareness | Change in postural awareness from baseline to the end of the third week. | Postural awareness will be evaluated using the Postural Awareness Scale (PAS). This self-reported Likert-type scale consists of 12 items, each rated from 1 (not at all true for me) to 7 (completely true for me), and is designed to assess an individuals awareness of their own body posture. |
| Upper extremity functionality | Change in upper extremity functionality from baseline to the end of the third week. | Upper extremity functionality will be assessed using the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). This patient-reported outcome measure consists of 11 items evaluating physical function and symptoms of the upper extremity, each with five response options, and yields a score ranging from 0 to 100 |
| Upper Limb Functionality | Change in functionality from baseline to the end of the third week. | Functionality will be assessed using the Lymphedema Functioning, Disability and Health Questionnaire for the Upper Limb (Lymph-ICF-UL). This descriptive and evaluative tool consists of 29 items assessing impairments, activity limitations, and participation restrictions in patients with lymphedema. The questionnaire is divided into five domains (physical function, mental function, household activities, mobility activities, and life/social activities) and each item is scored on a scale from 0 to 10. |
| Patient assessment of Quality of life | Change in quality of life from baseline to the end of the third week. | Quality of life will be assessed using the SF-12 Health Survey. This scale, developed to evaluate individuals' physical and mental health status, consists of 12 items and includes two main components: physical and mental health. The total score ranges from 0 to 100. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSerap Özgül, PhD
Outcome results
None listed