NCT04435639

Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

Can an Adjustable Compression Garment Replace Compression Bandaging in the Treatment of Patients With Breast Cancer Related Upper Limb Lymphoedema? A Pilot RCT Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Institute of Technology, Sligo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The experimental group will receive 5 treatments followed by a final assessment on the 6th visit over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes. They will then put on an Adjustable Compression sleeve (Juzo varocare adjustable compression system). Patients will be re-measured before the fourth treatment and again on session 6. At this point patients will receive a standard arm compression sleeve. This will be worn in alternation with their adjustable compression sleeve over the following 6 months. Patient will have their limb volume re-measured at the 6 month review. The control group will receive 5 treatments followed by a final assessment on the 6th visit over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes. They will then have their arm wrapped in Coban compression bandaging which will stay on until their next treatment. This will occur twice weekly for a period of 3 weeks. Patients will be Re-measured before the fourth treatment and again on session 6. At this point they will attend occupational therapy where they will receive 2 standard arm compression sleeves. The patient wears 1 sleeve every day over the following 6 months. Patient will have their limb volume re-measured at the 6 month review.

Conditions

• Lymphedema of Upper Arm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-04-30
• Completion: 2027-01-31
• First posted: 2020-06-17
• Last updated: 2024-10-26

Locations

1 site across 1 country: Ireland