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

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).

Usability evaluation of a novel compact pneumatic compression device for the treatment of lymphoedema: Pilot study

“…8 , 26 Two previous studies examined usability of PCD for lymphoedema: one included lower limb therapy and the other, treatment of the head and neck. 25 , 27 Both utilized a rating scale to determine device usability. This was also the approach taken in our study, which found that the use of the new PCD system was both comfortable and feasible for a single session.…”

Intermittent Pneumatic Compression for the Treatment of Lower Limb Lymphedema: A Pilot Trial of Sequencing to Mimic Manual Lymphatic Drainage Versus Traditional Graduated Sequential Compression

“…1 ), was designed to build on an earlier feasibility study, which utilized IPC delivered by the LymphAssist compared with a control group. 12 Ethical approval for this study was obtained from the appropriate local National Health Service Research Ethics Committee (LREC No. 18/WA/0114) and registered with ClinicalTrials.gov.…”

“…Participants ( n = 40) with primary ( n = 1) or secondary ( n = 39) lymphedema were recruited from two outpatient lymphedema clinics in the South East Wales area. 12 All participants had a confirmed diagnosis of stage II or III lower limb lymphedema as defined by the International Society of Lymphology; 33 participants had bilateral lower limb disease and 7 had unilateral. 13 All participants provided written informed consent.…”

Skin biomechanical properties and leg volume in aging healthy adults

“…Measurements were made utilizing a metric nonstretch tape measure (Medi Ltd, Germany). Leg circumference was measured at several points starting just above the malleolus and then at 4 cm intervals ascending the leg to the knee (the distal leg), and then from above the knee up to the upper thigh (the proximal leg) 5,6 . A portable hand‐held myotonometer (Myoton AS, Tallinn, Estonia) was used to quantitatively assess the skins mechanical and viscoelastic properties 9 .…”