Abstract
BackgroundLymphoedema is a chronic condition that causes swelling in the body tissues. Presently, there is no cure for lymphoedema; instead, current treatment is aimed at lifelong management to help control symptoms. Intermittent pneumatic compression (IPC) therapy can be considered as an adjunct to standard lymphoedema care; however, research regarding the efficacy of this treatment modality is limited.MethodsTwenty participants were recruited from an outpatient lymphoedema clinic (South Wales, UK) to a feasibility randomised control trial designed to evaluate the efficacy of an IPC device (LymphAssist, Huntleigh Healthcare) in reducing lower limb volume. The primary objective was to assess feasibility in terms of (1) study feasibility, including recruitment, retention and assessment of outcome measures, and (2) intervention feasibility, including intervention fidelity and acceptability to participants. Participants were randomly assigned to a control group (n = 10) or intervention group (n = 10). The control group received their standard lymphoedema care only for a 6-month period, whereas the intervention group received their standard lymphoedema care plus an IPC device to use for 6 months. A bilateral lower limb assessment and quality of life survey were undertaken at baseline and 3- and 6-month time points.ResultsThe study recruited to target within the planned time frame with a retention rate of 80%. Issues relating to potential recruitment bias and study attrition were identified and possible solutions explored. In addition, supplementary primary outcome measures that are important to the study population were identified and will be incorporated into the design of future studies.ConclusionThis feasibility study identified that a larger randomised controlled trial investigating the efficacy of home use IPC devices is feasible with modifications to the study protocol.Trial registrationThis trial is registered with clinicaltrials.gov (NCT03825263).
Highlights
Lymphoedema is a chronic condition that causes swelling in the body tissues due to an excess accumulation of protein-rich fluid called lymph
Such treatment is based on decongestive lymphatic therapy (DLT) which is a combination of manual lymph drainage (MLD), compression therapy, exercises and skin care; this is accepted internationally as the gold standard for successful lymphoedema management [4, 5]
Of the diaries returned by the intervention group, 75% (6/8) reported using the Intermittent pneumatic compression (IPC) device twice daily as recommended by the manufacturers at the 3-month review point; this figure had decreased to 66% (4/6) by the 6month review
Summary
Lymphoedema is a chronic condition that causes swelling in the body tissues due to an excess accumulation of protein-rich fluid called lymph This occurs as a result of lymphatic failure which can be genetic in origin (primary lymphoedema) or a consequence of damage to the lymphatics usually by trauma, inflammation and damage of the lymph nodes (secondary lymphoedema) [1]. There is no cure for lymphoedema; instead, current treatment is aimed at lifelong management to help control symptoms Such treatment is based on decongestive lymphatic therapy (DLT) which is a combination of manual lymph drainage (MLD), compression therapy, exercises and skin care; this is accepted internationally as the gold standard for successful lymphoedema management [4, 5]. Intermittent pneumatic compression (IPC) therapy can be considered as an adjunct to standard lymphoedema care; research regarding the efficacy of this treatment modality is limited
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