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Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

NCT04435639 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-26

No results posted yet for this study

Summary

This is a pilot randomised controlled trial investigating the use of an adjustable compression garment in the treatment of patients with Breast Cancer related upper limb Lymphoedema. This study will be conducted as part of a MSc qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place in the Physiotherapy Department of Sligo University Hospital (formerly Sligo General Hospital). The study will be conducted in conjunction with Sligo University Hospital and it has attained ethical approval through the relevant University Hospital Ethics Committee.

Conditions

  • Lymphedema of Upper Arm

Interventions

OTHER

Manual lymph drainage.

Manual Lymphatic drainage: Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period.

PROCEDURE

Coban compression bandage..

Coban compression bandaging: Patients will be wrapped in Coban compression bandaging which stays on until the next treatment. Patients will wear standard compression sleeves during the six month maintenance phase.

DEVICE

Adjustable Compression Sleeve

Patients wear an adjustable compression sleeve (Juzo varocare adjustable compression system) between treatments. They will be shown how to put it on and how to tighten the sleeve when needed. Patients will also wear the adjustable compression sleeve in alternation with a standard compression sleeve over a six month maintenance phase.

Sponsors & Collaborators

  • Sligo General Hospital

    collaborator OTHER

  • Institute of Technology, Sligo

    lead OTHER

Principal Investigators

  • Shane Gallagher, MSc · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2026-04-30
Completion
2027-01-31

Countries

  • Ireland

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 NCT04435639 on ClinicalTrials.gov