A non-randomized, open-label study of the safety and effectiveness of a novel non-pneumatic compression device (NPCD) for lower limb lymphedema.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
17 08 2022
17 08 2022
Historique:
received:
06
05
2022
accepted:
21
07
2022
entrez:
17
8
2022
pubmed:
18
8
2022
medline:
20
8
2022
Statut:
epublish
Résumé
Lower extremity lymphedema (LEL) can result in detriments to quality of life (QOL) and impose a significant economic burden on patients and payers. A common component of treatment is pneumatic compression, which requires patients to remain immobile. We investigated a novel non-pneumatic compression device (NPCD) that allows patients to remain active during compression treatment, to see if it reduces swelling and improves QOL. We conducted a non-randomized, open-label, 12-week pilot study of adult patients with primary or secondary unilateral LEL, and measured changes in limb edema and QOL using the Lymphedema Quality of Life Questionnaire (LYMQOL). Twenty-four subjects were enrolled; the majority were female (17) with secondary lymphedema (21). Eighteen completed the study. Statistically significant improvements were observed in overall QOL, aggregated LYMQOL total score, and three of four LYMQOL subscales (Function, Appearance, Mood). The fourth (Symptoms) trended toward significant improvement (p = 0.06). The average reduction in affected limb edema was 39.4%. The novel NPCD produced statistically significant improvements in QOL, functioning, and edema volume of patients with LEL. Innovations in devices to manage LEL can be effective while allowing patients to maintain mobility and physical activity during treatment.
Identifiants
pubmed: 35977981
doi: 10.1038/s41598-022-17225-9
pii: 10.1038/s41598-022-17225-9
pmc: PMC9385615
doi:
Types de publication
Clinical Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
14005Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2022. The Author(s).
Références
Scherer, K. & Khilnani, N. Evaluation and management of patients with leg swelling: Therapeutic options for venous disease and lymphedema. Semin. Intervent. Radiol. 38, 189–193. https://doi.org/10.1055/s-0041-1727162 (2021).
doi: 10.1055/s-0041-1727162
Tiwari, A., Cheng, K. S., Button, M., Myint, F. & Hamilton, G. Differential diagnosis, investigation, and current treatment of lower limb lymphedema. Arch. Surg. 138, 152–161. https://doi.org/10.1001/archsurg.138.2.152 (2003).
doi: 10.1001/archsurg.138.2.152
Dean, S. M. et al. The clinical characteristics of lower extremity lymphedema in 440 patients. J. Vasc. Surg. 8, 851–859. https://doi.org/10.1016/j.jvsv.2019.11.014 (2020).
doi: 10.1016/j.jvsv.2019.11.014
Keast, D. H., Moffatt, C. & Janmohammad, A. Lymphedema impact and prevalence international study: The Canadian data. Lymphat. Res. Biol. 17, 178–186. https://doi.org/10.1089/lrb.2019.0014 (2019).
doi: 10.1089/lrb.2019.0014
Vignes, S., Poizeau, F. & Dupuy, A. Cellulitis risk factors for patients with primary or secondary lymphedema. J. Vasc. Surg. 10, 179-185.e171. https://doi.org/10.1016/j.jvsv.2021.04.009 (2022).
doi: 10.1016/j.jvsv.2021.04.009
Dunberger, G. et al. Lower limb lymphedema in gynecological cancer survivors: Effect on daily life functioning. Support. Care Cancer 21, 3063–3070. https://doi.org/10.1007/s00520-013-1879-3 (2013).
doi: 10.1007/s00520-013-1879-3
Farrell, R., Gebski, V. & Hacker, N. F. Quality of life after complete lymphadenectomy for vulvar cancer: Do women prefer sentinel lymph node biopsy?. Int. J. Gynecol. Cancer 24, 813–819. https://doi.org/10.1097/IGC.0000000000000101 (2014).
doi: 10.1097/IGC.0000000000000101
Finnane, A., Hayes, S. C., Obermair, A. & Janda, M. Quality of life of women with lower-limb lymphedema following gynecological cancer. Expert Rev. Pharm. Outcomes Res. 11, 287–297. https://doi.org/10.1586/erp.11.30 (2011).
doi: 10.1586/erp.11.30
Stolldorf, D. P., Dietrich, M. S. & Ridner, S. H. A comparison of the quality of life in patients with primary and secondary lower limb lymphedema: A mixed-methods study. West J. Nurs. Res. 38, 1313–1334. https://doi.org/10.1177/0193945916647961 (2016).
doi: 10.1177/0193945916647961
Brown, J. C. et al. Physical activity, daily walking, and lower limb lymphedema associate with physical function among uterine cancer survivors. Support. Care Cancer 22, 3017–3025. https://doi.org/10.1007/s00520-014-2306-0 (2014).
doi: 10.1007/s00520-014-2306-0
Roberson, M. L. et al. Financial burden of lymphedema hospitalizations in the United States. JAMA Oncol. 7, 630–632. https://doi.org/10.1001/jamaoncol.2020.7891 (2021).
doi: 10.1001/jamaoncol.2020.7891
Zhang, X. et al. Association of lower extremity lymphedema with physical functioning and activities of daily living among older survivors of colorectal, endometrial, and ovarian cancer. JAMA Netw. Open 5, e221671. https://doi.org/10.1001/jamanetworkopen.2022.1671 (2022).
doi: 10.1001/jamanetworkopen.2022.1671
Abboud, A. et al. Lower limb lymphedema: An exploration of various treatment methods. Clin. Pediatr. Med. Surg. 38, 589–593. https://doi.org/10.1016/j.cpm.2021.06.011 (2021).
doi: 10.1016/j.cpm.2021.06.011
Maldonado, T. S. et al. Assessment of quality of life changes in patients with lower extremity lymphedema using an advanced pneumatic compression device at home. J. Vasc. Surg. 9, 745–752. https://doi.org/10.1016/j.jvsv.2020.10.013 (2021).
doi: 10.1016/j.jvsv.2020.10.013
Soran, A., Toktas, O., Grassi, A. & Sezgin, E. Adding pneumatic compression therapy in lower extremity lymphedema increases compliance of treatment, while decreasing the infection rate. Lymphat. Res. Biol. https://doi.org/10.1089/lrb.2020.0086 (2021).
doi: 10.1089/lrb.2020.0086
Desai, S. S. & Shao, M. Superior clinical, quality of life, functional, and health economic outcomes with pneumatic compression therapy for lymphedema. Ann. Vasc. Surg. 63, 298–306. https://doi.org/10.1016/j.avsg.2019.08.091 (2020).
doi: 10.1016/j.avsg.2019.08.091
Karaca-Mandic, P., Hirsch, A. T., Rockson, S. G. & Ridner, S. H. The Cutaneous, net clinical, and health economic benefits of advanced pneumatic compression devices in patients with lymphedema. JAMA Dermatol. 151, 1187–1193. https://doi.org/10.1001/jamadermatol.2015.1895 (2015).
doi: 10.1001/jamadermatol.2015.1895
Fukushima, T. et al. Immediate effects of active exercise with compression therapy on lower-limb lymphedema. Support. Care Cancer 25, 2603–2610. https://doi.org/10.1007/s00520-017-3671-2 (2017).
doi: 10.1007/s00520-017-3671-2
Keeley, V. C. S. et al. A quality of life measure for limb lymphoedema (LYMQOL). J. Lymphoedema 5, 26–37 (2010).
Muluk, S. C., Hirsch, A. T. & Taffe, E. C. Pneumatic compression device treatment of lower extremity lymphedema elicits improved limb volume and patient-reported outcomes. Eur. J. Vasc. Endovasc. Surg. 46, 480–487. https://doi.org/10.1016/j.ejvs.2013.07.012 (2013).
doi: 10.1016/j.ejvs.2013.07.012