Mirko Tessari1, Veronica Tisato2, Erika Rimondi2, Paolo Zamboni3, Anna Maria Malagoni3. 1. Department of Morphology, Surgery and Experimental Medicine, Unit of Translational Surgery, University Hospital of Ferrara, and Vascular Diseases Center, University of Ferrara, Ferrara, Italy. Electronic address: tssmrk@unife.it. 2. Department of Morphology, Surgery and Experimental Medicine and LTTA Center, University of Ferrara, Ferrara, Italy. 3. Department of Morphology, Surgery and Experimental Medicine, Unit of Translational Surgery, University Hospital of Ferrara, and Vascular Diseases Center, University of Ferrara, Ferrara, Italy.
Abstract
OBJECTIVE: We aimed to evaluate the effects of intermittent pneumatic compression (IPC) in patients at low mobility with leg edema. METHODS: A pilot, two-arm, randomized controlled clinical trial was performed. Fifty patients (age, 58.4 ± 9 years; male, 14), randomly allocated to a group (IPC) undergoing 1 month (n = 29) of an in-home cycle of IPC and to a control (C) group (n = 21), were studied. Leg edema was evaluated by measuring subcutaneous thickness (high-resolution ultrasound) and circumferences (metric tape), both assessed at different levels of the lower limbs, and volume (water plethysmography). Ankle range of motion (ROM, goniometer), quality of life (QoL) by the 36-Item Short Form Health Survey, and a pool of plasma inflammatory markers were also evaluated. RESULTS:Edema significantly decreased in the IPC group (for all outcome measures, P < .0001), whereas it significantly increased in the C group (P < .0001). Ankle ROM was significantly enhanced in the IPC group (dorsiflexion, P < .0001; plantar flexion, P = .002) and remained stable in the C group. QoL showed an improvement in the IPC group, particularly significant for the general health subscale (P = .004), whereas no changes were highlighted in the C group. The two groups exhibited different trends and variations for some plasma inflammatory markers, mainly for granulocyte colony-stimulating factor. CONCLUSIONS: In a sample of patients at reduced mobility with leg edema, IPC treatment was effective in reducing the edema, improving the ankle ROM, and determining a positive impact on QoL together with a slight modulation of some plasma inflammatory markers.
RCT Entities:
OBJECTIVE: We aimed to evaluate the effects of intermittent pneumatic compression (IPC) in patients at low mobility with leg edema. METHODS: A pilot, two-arm, randomized controlled clinical trial was performed. Fifty patients (age, 58.4 ± 9 years; male, 14), randomly allocated to a group (IPC) undergoing 1 month (n = 29) of an in-home cycle of IPC and to a control (C) group (n = 21), were studied. Leg edema was evaluated by measuring subcutaneous thickness (high-resolution ultrasound) and circumferences (metric tape), both assessed at different levels of the lower limbs, and volume (water plethysmography). Ankle range of motion (ROM, goniometer), quality of life (QoL) by the 36-Item Short Form Health Survey, and a pool of plasma inflammatory markers were also evaluated. RESULTS:Edema significantly decreased in the IPC group (for all outcome measures, P < .0001), whereas it significantly increased in the C group (P < .0001). Ankle ROM was significantly enhanced in the IPC group (dorsiflexion, P < .0001; plantar flexion, P = .002) and remained stable in the C group. QoL showed an improvement in the IPC group, particularly significant for the general health subscale (P = .004), whereas no changes were highlighted in the C group. The two groups exhibited different trends and variations for some plasma inflammatory markers, mainly for granulocyte colony-stimulating factor. CONCLUSIONS: In a sample of patients at reduced mobility with leg edema, IPC treatment was effective in reducing the edema, improving the ankle ROM, and determining a positive impact on QoL together with a slight modulation of some plasma inflammatory markers.
Authors: Wen Xie; Max A Levine; Shahid Aquil; Katharine Pacoli; Rafid Al-Ogaili; Patrick P Luke; Alp Sener Journal: Can Urol Assoc J Date: 2021-02 Impact factor: 1.862