Impress Lymphoedema Study (Intermittent Pneumatic Compression for treating lower limb phlebolymphoedema: a feasibility study (KESS 2 Studentship)
Lead Investigator /Research student
- Nyree Dunn
- Mark Williams, University of South Wales
- Michelle Fishbourne Cwm Taf University Health Board
- Gina Dolan, University of South Wales
- Jane Davies, Centre for Trials Research, Cardiff University
Type of study
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.
This feasibility study has identified several important issues that require consideration in the design of a larger-scale randomised control trial which will investigate the efficacy of IPC in the treatment of lymphoedema. Specifically, potential issues relating to recruitment bias and study attrition have been identified and possible solutions explored. In addition, supplementary primary outcome measures that are important to the study population have been identified and will be incorporated into the design of future studies. Whilst this feasibility study utilised a new generation IPC device which operated on a programme designed to mimic the MLD process (proximal to distal compression), there is also a need to evaluate the efficacy of the more commonly used, distal to proximal compression modes. Our planned future study will therefore randomise participants to utilise the IPC device on one of these compression modes for the intervention period of the study.
Who is the study sponsor?
University of South Wales
Total grant value
How could this research potentially benefit patients?
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). It can affect any part of the body but usually occurs in the arms or legs and has an estimated prevalence of between 2.29 and 3.59 cases per 1000 of the general population in the UK.
Key characteristics of lymphoedema include an increase in limb size and skin changes, as well as increased limb heaviness and pain, which have negative sequelae for both physical and psychosocial health. Presently, 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.
This feasibility study aimed to evaluate a proposed methodology designed to assess the efficacy of IPC for the treatment of lower limb lymphoedema.
- Trial registration: https://clinicaltrials.gov/ct2/show/NCT03825263
Dunn N, Williams EM, Fishbourne M, Dolan G, Davies JH. 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. PMID: 31583112; PMCID: PMC6767651.