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

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.

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

© The Author(s). 2019.

Figures

Fig. 1
Fig. 1
Inclusion and exclusion criteria
Fig. 2
Fig. 2
IPC device in use (LymphAssist, Huntleigh Healthcare)
Fig. 3
Fig. 3
Participant flow

References

    1. Zaleska M, Olszewski WL, Durlik M. The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. Lymphat Res Biol. 2014;12(2):103–109. doi: 10.1089/lrb.2013.0033.
    1. Cooper G, Bagnall A. Prevalence of lymphoedema in the UK: focus on the southwest and West Midlands. Br J Community Nurs. 2016;21(4):6–14. doi: 10.12968/bjcn.2016.21.Sup4.S6.
    1. Wigg J. A pilot randomised control trial to compare a new intermittent pneumatic compression device and 12 chamber garment with current best practice in the management of limb lymphoedema. Eur J Lymphology Relat Probl. 2009;20(58):16–23.
    1. Liao SF, Li SH, Huang HY. The efficacy of complex decongestive physiotherapy (CDP) and predictive factors of response to CDP in lower limb lymphedema (LLL) after pelvic cancer treatment. Gynecol Oncol. 2012;125(3):712–715. doi: 10.1016/j.ygyno.2012.03.017.
    1. International Society of Lymphology The diagnosis and treatment of peripheral lymphedema: 2016 consensus document of the international society of lymphology. Lymphology. 2016;49:170–184.
    1. Taradaj J, Rosinczuk J, Dymarek R, Halski T, Schneider W. Comparison of efficacy of the intermittent pneumatic compression with a high-and-low pressure application in reducing the lower limbs phlebolymphedema. Ther Clin Risk Manag. 2015;11:1545–1554.
    1. Johansson K, Lie E, Ekdhal C, Lindfelt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998;31:56–64.
    1. Toma E, Vanzi V. Observational retrospective study on the effectiveness of sequential graduated intermittent pneumatic compression therapy of lower limbs edema. Sens Sci. 2016;3(3):228–234.
    1. Muluk SC, Hirsch AT, Taffe EC. Pneumatic compression device treatment of lower extremity lymphedema elicits improved limb volume and patient-reported outcomes. Eur J Vasc Endovasc Surg. 2013;46(4):480–487. doi: 10.1016/j.ejvs.2013.07.012.
    1. Lee N, Wigg J, Pugh S, Barclay J, Moore H. Lymphoedema management with the LymphFlow Advance pneumatic compression pump. Br J Community Nurs. 2016;21(10):13–19. doi: 10.12968/bjcn.2016.21.Sup10.S13.
    1. International Lymphoedema Framework . Best practice for the management of lymphoedema – International consensus. 2012. p. 2.
    1. Endicott J, Nee J, Harrison W, Blumenthal R. Quality of life enjoyment and satisfaction questionnaire: a new measure. Psychopharmacol Bull. 1993;29:321–326.
    1. Williams AF, Whitaker J. Measuring change in limb volume to evaluate lymphoedema treatment outcome. EWMA J. 2015;15(1):27–32.
    1. Higgins JPT, Altman DG. Assessing risk of bias in included studies. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. Chichester: Wiley; 2008. pp. 187–242.
    1. Greene Arin K., Slavin Sumner A., Brorson Håkan. Lymphedema. Cham: Springer International Publishing; 2015. Uncommon Procedures for Lymphedema; pp. 243–246.
    1. Brierley G, Brabyn S, Togerson D, Watson J. Bias in recruitment to cluster randomized trials: a review of recent publications. J Eval Clin Pract. 2012;18:878–886. doi: 10.1111/j.1365-2753.2011.01700.x.
    1. Kadam RA, Borde SU, Madas SA, Salvi SS, Limaye SS. Challenges in recruitment and retention of clinical trial subjects. Perspect Clin Res. 2016;7(3):137–143. doi: 10.4103/2229-3485.184820.
    1. Page SJ, Persch AC. Recruitment, retention, and blinding in clinical trials. Am J Occup Ther. 2013;67:154–161. doi: 10.5014/ajot.2013.006197.
    1. Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19:227–233. doi: 10.1111/j.1365-2702.2009.03041.x.
    1. Purcell A, Buckley T, King J, Moyle W, Marshall AP. Eutectic mixture of local anaesthetics (EMLA®) as a primary dressing on painful chronic leg ulcers: a pilot randomised controlled trial. Pilot Feasibility Stud. 2018;4:123. doi: 10.1186/s40814-018-0312-6.
    1. Dong Y, Peng CY. Principled missing data methods for researchers. springerplus. 2013;2(1):222. doi: 10.1186/2193-1801-2-222.
    1. Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ. 2002;324:1193. doi: 10.1136/bmj.324.7347.1193.
    1. Blondin JM, Abu-Hasaballah KS, Tennen H, Lalla RV. Electronic versus paper diaries: a pilot study of concordance and adherence in head and neck cancer patients receiving radiation therapy. Head Neck Oncol. 2010;2:29. doi: 10.1186/1758-3284-2-29.
    1. Schoenrock B, Zander V, Dern S, Limper U, Mulder E, Veraksits A, Viir R, Kramer A, Stokes MJ, Salanova M, Peipsi A, Blottner D. Bed rest, exercise countermeasure and reconditioning effects on the human resting muscle tone system. Front Physiol. 2018. 10.3389/fphys.2018.00810.
    1. Devoogdt N, De Groef A, Hendrickx A, Damstra R, Christiaansen A, Geraerts I, Vervloesem N, Vergote I, Van Kampen M. Lymphoedema Functioning, Disability and Health Questionnaire for Lower limb Lymphoedema (lymph-ICF-LL): reliability and validity. Phys Ther. 2014;94(5):705–721. doi: 10.2522/ptj.20130285.

Source: PubMed

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