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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).

SUBMITTER: Dunn N

PROVIDER: S-EPMC6767651 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Dunn Nyree N Williams E Mark EM Fishbourne Michelle M Dolan Gina G Davies Jane H JH

Pilot and feasibility studies 20190930

<h4>Background</h4>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.<h4>Methods</h4>Twenty participants were recruited from an outpatient lymphoedema cl ...[more]

PMID: 31583112

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Project description:PURPOSE AND HYPOTHESIS:Adjuvant intermittent pneumatic compression (IPC) during leg immobilization following Achilles tendon rupture (ATR) has been shown to reduce the risk of deep venous thrombosis. The purpose of this study was to investigate whether IPC can also promote tendon healing. METHODS:One hundred and fifty patients with surgical repair of acute ATR were post-operatively leg immobilized and prospectively randomized. Patients were allocated for 2 weeks of either adjuvant IPC treatment (n = 74) or treatment-as-usual (n = 74) in a plaster cast without IPC. The IPC group received 6 h daily bilateral calf IPC applied under an orthosis on the injured side. At 2 weeks post-operatively, tendon healing was assessed using microdialysis followed by enzymatic quantification of tendon callus production, procollagen type I (PINP) and type III (PIIINP) N-terminal propeptide, and total protein content. 14 IPC and 19 cast patients (control group) consented to undergo microdialysis. During weeks 3-6, all subjects were leg-immobilized in an orthosis without IPC. At 3 and 12 months, patient-reported outcome was assessed using reliable questionnaires (ATRS and EQ-5D). At 12 months, functional outcome was measured using the validated heel-rise test. RESULTS:At 2 weeks post-rupture, the IPC-treated patients exhibited 69% higher levels of PINP in the ruptured Achilles tendon (AT) compared to the control group (p = 0.001). Interestingly, the IPC-treated contralateral, intact AT also demonstrated 49% higher concentrations of PINP compared to the non-treated intact AT of the plaster cast group (p = 0.002). There were no adverse events observed associated with IPC. At 3 and 12 months, no significant (n.s.) differences between the two treatments were observed using patient-reported and functional outcome measures. CONCLUSIONS:Adjuvant IPC during limb immobilization in patients with ATR seems to effectively enhance the early healing response by upregulation of collagen type I synthesis, without any adverse effects. Whether prolonged IPC application during the whole immobilization period can also lead to improved long-term clinical healing response should be further investigated. The healing process during leg immobilization in patients with Achilles tendon rupture can be improved through adjuvant IPC therapy, which additionally prevents deep venous thrombosis. LEVEL OF EVIDENCE:Randomized controlled trial, Level I.

Project description:IntroductionVenous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, is a common and potentially fatal post-surgery complication. Research has shown that 50% of VTE causes are intraoperative, with the risk of occurrence highest during and immediately post-surgery. Therefore, strategies for early assessment and prevention should be established.ObjectiveTo identify optimal equipment selection, compression protocols, and strategies for complication prevention and management during intraoperative intermittent pneumatic compression (IPC), this study aims to synthesize the best available evidence. The objective is to inform accurate risk assessment and facilitate early mechanical prophylaxis against venous thrombosis.MethodsThe Practical Application to Clinical Evidence model proposed by the Joanna Briggs Institute was utilized. Indicators were identified using the available best evidence from January 2023 to October 2023, and a baseline review was conducted. Negative factors were identified based on clinical evidence-based practice. The implementation rates of different indicators before (n = 372) and after (n = 405) evidence-based practice, the incidence rates of intraoperative IPC-related adverse events and VTE, and the risk of venous thrombosis before (n = 50) and after (n = 50) practice were identified and compared. Furthermore, medical staff's knowledge of best practices for intraoperative IPC was assessed through pre- and post-intervention surveys involving 109 operating room personnel.ResultsAll review indicators significantly improved (P < 0.01) after the evidence-based practice, and 9 reached 100%. Two intraoperative venous thrombosis events occurred before the evidence-based practice, with an incidence rate of 0.53%; no intraoperative venous thrombosis event occurred after the evidence-based practice, with no significant difference (X2 = 2.171, P = 0.141 > 0.05). However, there were significant differences in intraoperative venous blood hemodynamics before and after the practice (P < 0.05). Moreover, 9 IPC-related adverse events, including 4 cases of skin pressure, 3 cases of skin allergy, and 2 cases of lower limb circulation disorders, were reported before the evidence-based practice, with an incidence rate of 2.4%. Notably, no intraoperative IPC-associated adverse events occurred after the evidence-based practice(X2 = 9.913, P < 0.01). Meanwhile, the score of comprehension of the standard utilization of IPC for preventing venous thrombosis by medical staff in the operating room was 93.34 ± 3.64 after the evidence-based practice, which was higher than that (67.55 ± 5.45) before the evidence-based practice. Overall, the clinical practice was significantly improved the evidence-based practice.ConclusionsApplying intraoperative IPC utilization standards based on the best evidence in clinical practice effectively reduces the intraoperative IPC-associated adverse event rate and the risks of intraoperative venous thrombosis. It also improves the execution rates and compliance with mechanical prevention standards in the operating room by medical staff. Future research should prioritize the development and refinement of best clinical practices for intraoperative venous thrombosis prevention, with a particular emphasis on the integration of mechanical prophylaxis strategies.

Dataset Information

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

Publications

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

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