Using an Adjustable Compression Garment for Secondary Upper Limb

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04435639
Study type	Interventional
Source	Institute of Technology, Sligo
Contact	Kenneth Monaghan, PhD
Phone	0879480448
Email	monaghan.kenneth@itsligo.ie
Status	Not yet recruiting
Phase	N/A
Start date	October 30, 2020
Completion date	January 31, 2022

View Details

See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT04139291` - Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy	N/A
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Recruiting	`NCT06144164` - A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer	Phase 3
Completed	`NCT05278871` - Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors	N/A
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Recruiting	`NCT04908254` - A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema	N/A
Completed	`NCT04881604` - Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	N/A
Recruiting	`NCT05203835` - Trial of Acebilustat for the Treatment of Upper Arm Lymphedema	Phase 2
Recruiting	`NCT04934098` - Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema	N/A
Recruiting	`NCT04203069` - Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase	N/A
Withdrawn	`NCT04246034` - Microvascular Breast Reconstruction With Lymph Node Transfer	N/A
Completed	`NCT04213001` - Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema	N/A
Recruiting	`NCT04690439` - Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms