Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

NCT ID: NCT04435639

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2027-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MLD + Adjustable Compression Sleeve.

Manual lymph drainage + Adjustable Compression Sleeve.

Group Type: EXPERIMENTAL

Manual lymph drainage.

Intervention Type: OTHER

Manual Lymphatic drainage:

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

Adjustable Compression Sleeve

Intervention Type: DEVICE

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.

MLD + Coban Compression Bandage.

Manual lymphatic drainage + Coban compression bandaging.

Group Type: ACTIVE_COMPARATOR

Manual lymph drainage.

Intervention Type: OTHER

Manual Lymphatic drainage:

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

Coban compression bandage..

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Upper limb lymphoedema (secondary to breast cancer) diagnosed by a consultant
• Aged > 18 years.
• Males and females.
• Stage 2 Lymphoedema.
• >10% volume difference between upper limbs.
• Cognitive ability to understand the programme.

Exclusion Criteria

• Involvement in other studies or rehabilitation programmes.
• Active infection disease progression.
• Congestive Cardiac Failure.
• Non-English speakers.
• Under 18's.
• Poor cognition for treatment compliance or consent.
• Pregnant, or currently breast feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sligo General Hospital

OTHER

Sponsor Role: collaborator

Institute of Technology, Sligo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shane Gallagher, MSc

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Atlantic Technological University

Sligo, , Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ITSligo SG

Identifier Type: -

Identifier Source: org_study_id