NCT07217288

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Lahore University of Biological and Applied Sciences · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema, Breast Cancer
• Mastectomy Related Lymphedema
• Post Mastectomy Lymphedema

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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 limb, prevent fibrosis and infection, and enhance mobility and quality of life in post-mastectomy lymphedema patients.

Timeline

• Start date: 2025-10-26
• Primary completion: 2027-03-31
• Completion: 2027-04-30
• First posted: 2025-10-15
• Last updated: 2025-10-15

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated device study