Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

Not Applicable

Suspended

• Conditions: Lymphedema of Upper Arm
• Interventions: Other: Manual lymph drainage.; Procedure: Coban compression bandage..; Device: Adjustable Compression Sleeve

• Registration Number: NCT04435639
• Lead Sponsor: Institute of Technology, Sligo

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.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Study Start: 2025-10-30
• Primary Completion: 2026-04-30
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MLD + Adjustable Compression Sleeve.	Manual lymph drainage.	Manual lymph drainage + Adjustable Compression Sleeve.
MLD + Coban Compression Bandage.	Manual lymph drainage.	Manual lymphatic drainage + Coban compression bandaging.
MLD + Coban Compression Bandage.	Coban compression bandage..	Manual lymphatic drainage + Coban compression bandaging.
MLD + Adjustable Compression Sleeve.	Adjustable Compression Sleeve	Manual lymph drainage + Adjustable Compression Sleeve.

Primary Outcome Measures

Name	Time	Method
Limb Volume - Circumferential Measurements.	Over a 6 month period. (10 min testing time)	Limb Volume- circumferential measurements taken at 4cm intervals from the wrist up to the axilla.; The circumferences were then entered into a spreadsheet and a truncated cone formula applied with each segment volume calculated: Vs = h(Ct x Ct + Ct x Cb x Cb) 12 π; where (Vs) was volume of a segment, (h) was the distance between two points of measurement, (Ct) represented the circumference at the top measurements of the segment, (Cb) represented the circumference at the base of the segment, π = Pi. Once each segment is calculated, the sum of all segments of the arm are computed into a volume estimate. This method was found to be valid (criterion validity)in several studies when compared to the gold standard of water displacement with intra-class correlation coefficient (ICC) of \>0.95. The higher the score the more lymphoedema present.
Short Form 36 (SF-36): Quality of Life questionnaire.	Over a 6 month period. (10 min testing time)	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting for routine monitoring and assessment of care outcomes in adult patients.It is scored 0-100 with a lower score indicating more disability.

Trial Locations

Locations (1)

Atlantic Technological University; 🇮🇪 Sligo, Ireland