Effectiveness of Complete Decongestive-versus Non-pneumattic- Compression Therapy in Patients With Post-mastectomy Lymphedema
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Lahore University of Biological and Applied Sciences
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Pain measured by visual analogue scale.
Overview
Brief Summary
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.
Detailed Description
Post-mastectomy lymphedema (PML) is a chronic, progressive, and disabling complication affecting breast cancer survivors due to disruption of lymphatic drainage following surgery or radiotherapy. It leads to swelling, pain, restricted range of motion, recurrent infections, and reduced quality of life.
Complete Decongestive Therapy (CDT) - a multimodal approach involving manual lymphatic drainage, compression bandaging, skin care, and exercise - is currently the gold standard for lymphedema management. However, CDT is time-consuming, therapist-dependent, and often poorly tolerated or inaccessible for long-term self-management.
Non-Pneumatic Compression Therapy (NPCD) is a newer, portable, and wearable device that provides gradient sequential compression while allowing mobility and daily activity during treatment. It potentially improves adherence, comfort, and patient satisfaction.
Limited comparative research exists evaluating the relative effectiveness of CDT and NPCD in post-mastectomy lymphedema. This study aims to fill this gap and determine which approach produces superior clinical and functional outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
- •An acute infection within the previous 4 weeks
- •Active venous thromboembolic edema
- •Pregnant women and women who are planning or nursing at study entry.
- •Patients who had participated in any clinical trial of an investigational substance or device during the previous 30 days
- •Potential patients with a cognitive or physical impairment that would interfere with appropriate use of the device. (Rockson, Whitworth, et al., 2022)
Outcomes
Primary Outcomes
Pain measured by visual analogue scale.
Time Frame: Assessment will be done at baseline, 4th week and 8th week.
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).
Secondary Outcomes
- Edema volume by water displacement method(Assessment will be done at baseline, 4th week and 8th week.)
- Quality of life measured by Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL)(Assessment will be done at baseline, 4th week and 8th week)
- Functional mobility measured by upper extremity functional index(Assessment will be done baseline, 4th week and 8th week)
- Upper limb range of motion measured by goniometer(Assessment will be done at baseline, after 4th week and 8th week)
- Respiratory functions measured by spirometer(Assessment will be done baseline, 4th week and 8th week)
- Inflammatory markers CK, CRP, IL-6, and TNF-α(Assessment will be done at baseline, after 4th week and 8th week)
Investigators
Sahar Fatima
Sahar Fatima
Lahore University of Biological and Applied Sciences