Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study

Nyree Dunn; E Mark Williams; Michelle Fishbourne; Gina Dolan; Jane H Davies

doi:10.1186/s40814-019-0496-4

Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study

Pilot Feasibility Stud. 2019 Sep 30:5:113. doi: 10.1186/s40814-019-0496-4. eCollection 2019.

Authors

Nyree Dunn¹, E Mark Williams¹, Michelle Fishbourne², Gina Dolan¹, Jane H Davies³

Affiliations

¹ 1Faculty of Life Sciences, University of South Wales, Lower Glyntaff Campus, Room AB034, Treforest, Pontypridd, CF37 4BD UK.
² 2Dewi Sant Hospital, Cwm Taf University Health Board, Pontypridd, UK.
³ 3Centre for Trials Research, Cardiff University, Cardiff, UK.

Abstract

Background: Lymphoedema 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.

Methods: Twenty 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.

Results: The 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.

Conclusion: This 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 registration: This trial is registered with clinicaltrials.gov (NCT03825263).

Keywords: Intermittent pneumatic compression; Leg volume; Lymphoedema.

Associated data

ClinicalTrials.gov/NCT03825263