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

NCT07217288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-10-15

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Lahore

    collaborator OTHER
  • Lahore University of Biological and Applied Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-26
Primary Completion
2027-03-31
Completion
2027-04-30
FDA Device
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217288 on ClinicalTrials.gov