Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

NCT04435639 | Suspended

• 1 other identifier: ITSligo SG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema of Upper Arm

Keywords

Breast cancer related lymphoedema.; Compression bandaging.

Outcome Measures

Primary Outcomes (2)

• Limb Volume - Circumferential Measurements.

  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.

  Over a 6 month period. (10 min testing time)

• Short Form 36 (SF-36): Quality of Life questionnaire.

  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.

  Over a 6 month period. (10 min testing time)

Study Arms (2)

MLD + Adjustable Compression Sleeve.

EXPERIMENTAL

Manual lymph drainage + Adjustable Compression Sleeve.

Other: Manual lymph drainage.; Device: Adjustable Compression Sleeve

MLD + Coban Compression Bandage.

ACTIVE COMPARATOR

Manual lymphatic drainage + Coban compression bandaging.

Other: Manual lymph drainage.; Procedure: Coban compression bandage..

Interventions

Manual lymph drainage. OTHER

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

MLD + Adjustable Compression Sleeve.; MLD + Coban Compression Bandage.

Coban compression bandage.. 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.

MLD + Coban Compression Bandage.

Adjustable Compression Sleeve 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 + Adjustable Compression Sleeve.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Technology, Sligo: lead
• Sligo General Hospital: collaborator

Study Sites (1)

Atlantic Technological University

Sligo, Ireland

Location

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Shane Gallagher, MSc

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was blinded to treatment allocation. They evaluated participant's prior to treatment commencing and after treatment has been completed and compression garment/ compression bandaging has been removed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Randomised Controlled Trial

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: October 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

IE (1)