Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema

Официальное название

Effectiveness of Complete Decongestive-versus Non-pneumattic- Compression Therapy in Patients With Post-mastectomy Lymphedema

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Non Pneumatic compression device
  Non-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.
• Другое Complete Decongestive therapy
  Complete 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 lim

Первичные конечные точки

• Pain measured by visual analogue scale. [Срок оценки: Assessment will be done at baseline, 4th week and 8th week.]

Вторичные конечные точки (6)

• Edema volume by water displacement method [Срок оценки: 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) [Срок оценки: Assessment will be done at baseline, 4th week and 8th week]
• Functional mobility measured by upper extremity functional index [Срок оценки: Assessment will be done baseline, 4th week and 8th week]
• Upper limb range of motion measured by goniometer [Срок оценки: Assessment will be done at baseline, after 4th week and 8th week]
• Respiratory functions measured by spirometer [Срок оценки: Assessment will be done baseline, 4th week and 8th week]
• Inflammatory markers CK, CRP, IL-6, and TNF-α [Срок оценки: Assessment will be done at baseline, after 4th week and 8th week]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Cancer Care Hospital — Lahore

Идентификаторы

NCT: NCT07217288 · UOL/IREB/25/12/0042 · U1111-1329-7030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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