The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined with routine physical therapy, in reducing pain and edema volume, improving range of motion, respiratory function, inflammatory markers, and overall quality of life in patients with post-mastectomy lymphedema.
Females with age between 30 to 60 years. (Monticciolo et al., 2021)
Females with unilateral mastectomy post three months of surgery. (Shen et al., 2023) 21
A volume difference to the circumferential measurements between the affected and unaffected upper extremities of more volume difference>10%.
Completed chemotherapy and/or radiation therapy. (Borman, Yaman, Yasrebi, İnanlı, & Dönmez, 2022)
Systemic disorders that might contraindicate the use of sequential compression therapy i.e. chronic kidney disease with renal failure, Congestive heart failure, neurological disorders, respiratory disorders.
Presence of active cellulitis, open and partially healed wounds.
Patients with lipedema
Active or recurrent cancer (defined as < 3 months since completion of cancer therapy)
Parallel
Non Pneumatic compression device
DeviceNon-Pneumatic Compression Device (NPCD) is a wearable, portable system providing gradient sequential compression through shape-memory alloy actuators instead of air pressure. Frequency: 5 sessions per week for 8 weeks. Intensity: Moderate, rhythmic static and dynamic compression applied distally to proximally, allowing safe lymphatic drainage. Time: 40 minutes per session, once daily.
Complete Decongestive therapy
Other interventionComplete Decongestive Therapy (CDT), is the gold-standard, non-invasive treatment for lymphedema. It combines manual lymphatic drainage (MLD), compression bandaging, exercise therapy, and skin care to reduce limb swelling and improve lymphatic flow. Frequency: 5 sessions per week for 8 weeks. Intensity: Gentle manual drainage with multilayer compression Time: 60 minutes per session. Type: Therapist-guided manual and compression therapy followed by self-management. CDT aims to decongest the limb, prevent fibrosis and infection, and enhance mobility and quality of life in post-mastectomy lymphedema patients.
Pain measured by visual analogue scale.
Lymphedema-related symptoms (pain, pressure, heaviness and hardness). The visual analogue scale (VAS) is a validated, subjective measure for acute or chronic pain. Scores are based on self-reported measures of symptoms from 0-10 score. With zero "no pain" and 10 "worst pain". Test-rater reliability has been shown to be good, but higher among literate (r= 0.94, P=0.001) than illetrate patients (r= 0.71, P=0.001).
Edema volume by water displacement method
In the volumetric assessment of lymphedema, the water displacement method involves submerging the affected limb in a water-filled container and measuring the amount of water displaced. The volume change will be determined by subtracting the initial water volume from the final volume after immersing the limb, providing an estimation of limb volume.
Quality of life measured by Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL)
Quality of life will be assessed using Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL). The Lymph-ICF-UL consists of 29 questions. The questionnaire consists of 5 domains: the physical function domain contains 7 questions; the mental function domain contains 4 questions; the household domain contains 4 questions; the mobility domain contains 8 questions; and the life/ social life domain contains 6 questions. Each question has to be scored on an 11-point scale (0 to 10). The anchor points for the physical and mental function domain and household domain are 'not at all' and 'a lot'. Those for the mobility and life domain/ social life domain are 'very well' and 'not at all'. The patient has to score his/ her average problems in functioning (i.e. impairments in function and activity limitations and participation restrictions) due to the upper limb lymphoedema.
Functional mobility measured by upper extremity functional index
The Upper Extremity Functional Index used for measuring the functional mobility of patients with breast related lymphedema. The UEF consists of 20 items, each scored on a 5-point Likert scale ranging from: 0 = Extreme difficulty or unable to perform activity, 1 = Quite a bit of difficulty, 2 = Moderate difficulty, 3 = A little bit of difficulty, 4 = No difficulty. The total score ranges from 0 to 80, with higher scores indicating greater functional ability.
Upper limb range of motion measured by goniometer
The shoulder flexion ROM will be assessed using a 12-inch plastic goniometer. The measurement will be taken with the patient in supine lying with knees flexed, the palm facing medially, and thumbs up. The assessor stood at the side of the affected arm to perform the measurement, with the goniometer axis placed on the middle of the humeral head laterally, the stationary arm parallel with the trunk, and the moveable arm in line with the midline of the humerus. The patient will be instructed to perform flexion (with elevation) of both shoulders to avoid compensatory movement of the affected side. The angle of maximum shoulder flexion measured by the goniometer will be recorded in degrees (°). The intrarater reliability for assessing shoulder flexion ROM using a goniometer has been reported to be excellent (ICC = 0.95, 95% CI = 0.89-0.98)
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Lahore University of Biological and Applied Sciences
Lead sponsor
University of Lahore
Collaborator
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