Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

Institute of Technology, Sligo

Status: Suspended

Conditions: Lymphedema of Upper Arm

Treatments: Device: Adjustable Compression Sleeve; Other: Manual lymph drainage.; Procedure: Coban compression bandage..

Study type: Interventional

Funder types: Other

Identifiers

NCT04435639

ITSligo SG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

MLD + Adjustable Compression Sleeve.

Experimental group

Description:

Manual lymph drainage + Adjustable Compression Sleeve.

Treatment:

Other: Manual lymph drainage.

Device: Adjustable Compression Sleeve

MLD + Coban Compression Bandage.

Active Comparator group

Description:

Manual lymphatic drainage + Coban compression bandaging.

Treatment:

Procedure: Coban compression bandage..

Other: Manual lymph drainage.