Search

Background: Optimal frequency and duration of pneumatic compression device (PCD) therapy for lymphedema is undetermined. This prospective, randomized preliminary study evaluated the impact of different PCD dosing protocols on physiological and patient-reported outcomes (PROs) to estimate treatment effects, assess the responsiveness of various measurement techniques, and identify endpoints for a definitive PCD dosing trial. Methods and Results: Twenty-one patients with lower extremity lymphedema were randomized into three groups for treatment with the Flexitouch advanced PCD: (A) once per day for 1 hour, 12 consecutive days; (B) twice per day in 1-hour treatments, 5 consecutive days; or (C) twice per day in 2-hour treatments, 5 consecutive days. Outcomes measured were changes in limb volume (LV), tissue fluid, tissue tone, and PROs. Those in group A experienced mean (standard deviation) LV reductions of 109 (58) mL ( p  = 0.003) on day 1 and of 97 (86) mL ( p  = 0.024) on day 5. Group A also showed possible single-treatment decreases in extracellular fluid volume by bioimpedance spectroscopy (BIS) on day 5. There were no consistent changes in groups B and C. Long-term assessment of LV and BIS showed no clear change. Tonometry, ultrasound, local tissue water, and PROs showed wide variation among participants. Conclusions: LV measurements showed potential benefit for 1-hour daily PCD treatment. A definitive dosing trial should include LV, BIS, and PROs in a comparison of 1- and 2-hour daily treatment protocols conducted over a study period of 4 weeks. These data may inform appropriate outcome measures for other intervention studies in lymphedema.

Background: Recent advances in technology have allowed intermittent pneumatic compression (IPC) devices to develop so that their function mimics the process and principles of manual lymphatic drainage (MLD); however, research into the effectiveness of such devices is lacking. This study aimed to investigate the effectiveness of a patented IPC technique designed to mimic MLD (the LymphAssist), compared with a typical sequential IPC regimen. Methods and Results: Forty patients with a confirmed diagnosis of lower limb ISL (International Society of Lymphology) stage II or III lymphedema were recruited into this three-phased study. A bilateral leg volume assessment and quality-of-life assessment were completed at four clinic visits across the course of the study. The LymphAssist IPC regimen was significantly more effective in reducing distal leg volume than the sequential mode (mean volume reduction: 230 ± 135 mL vs. 140 ± 84 mL, respectively, p  = 0.01). Improvements in leg volume were transient as both groups demonstrated a rebound or increase in volume during the washout period (LymphAssist: 238 ± 168 mL, sequential: 276 ± 158 mL, p  = 0.3). Overall, IPC was effective in improving quality-of-life scores (mean reduction: 10 ± 11, p  < 0.001). Conclusion: IPC is effective in reducing limb volume and improving quality of life for patients with lower limb lymphedema. IPC that mimics the MLD process has been shown to be more effective in reducing leg volume compared with traditional sequential IPC in the distal aspect of the leg. The increase in leg volume observed after discontinuation of IPC suggests that regular treatment is required to maintain its associated effects. Clinical Trial Registration Number: NTC 03856281.

Background: Upper limb lymphedema may be revealed after breast cancer and its treatment. Among different treatment approaches, intermittent pneumatic compression (IPC) therapy and low-level laser therapy (LLLT) are reported as effective modalities in the treatment of postmastectomy upper limb lymphedema (PML). The aim of the current study is to investigate the long-term effectiveness of combined IPC plus LLLT versus IPC therapy alone in patients with PML. Methods and Results: The patients were allocated into two groups in this single-blinded, controlled clinical trial. Group I received combined treatment with IPC plus LLLT ( n  = 21) and group II received only IPC ( n  = 21). IPC treatment was given 5 sessions per week for 4 weeks (20 sessions). LLLT was also performed 5 sessions per week for 4 weeks (20 sessions). Clinical evaluations were performed before and after the treatment at the 3, 6, and 12-month follow-up visits. According to within-group analysis, statistically significant improvements in the circumference difference ( C diff ) and grip strength were observed in both groups (for C diff , p  = 0.018 and p  = 0.032, respectively; for grip strength, p  = 0.001 and p  = 0.046, respectively). Visual analog scale values for arm pain and shoulder pain during motion were decreased only in group I. Conclusion: Both interventions have positive effects on lymphedema, grip strength, and pain. Long-term effects of combined therapy, especially on pain, are slightly superior to the pneumatic compression alone.

Background: Lack of diagnostic awareness of lipedema and frequent confusion with obesity or lymphedema may be an obstacle for treatment. The clinical effects of conservative treatment methods are not clearly known. This study investigated the effects of exercise-based rehabilitation combined with complete decongestive therapy (CDT) or intermittent pneumatic compression therapy (IPCT) or alone in patients with severe lipedema. Methods: Thirty-three women with severe (type 3, stage III or IV) lipedema diagnosed according to the revised-Wold criteria were randomized into three groups: Group 1 (CDT plus exercises), Group 2 (IPCT plus exercises), and Group 3 (control-exercises alone). All groups received 30 sessions of combined (aerobic, strengthening, and stretching) exercise program. In addition, there were CDT in Group 1 and IPCT in Group 2 five times a week for 6 weeks. The primary outcome measure was the limb volume measurements. The secondary outcome measures were anthropometric measurements (body weight, body mass index, waist-to-height ratio, waist-to-hip ratio), 6-minute walk test, visual analog scale for pain, fatigue severity scale, Beck Depression Inventory, and Short Form Health Survey-36 (SF-36). Results: Thirty-one participants completed the interventions. Limb volumes ( p  = 0.017, ηp 2  = 0.562 for right; p  < 0.001, ηp 2  = 0.775 for left), pain ( p  = 0.045, ηp 2  = 0.199), and physical functioning subscore of SF-36 ( p  = 0.040, ηp 2  = 0.465) differed significantly between treatments originating from Group 1. Conclusions: All programs improved outcome measurements after the intervention. However, when the difference between treatments was investigated, CDT administered in addition to the exercises has been shown to provide significant improvements in reducing limb volumes, pain, and physical function. Clinical trial registration number: The study was registered at the US National Institutes of Health (ClinicalTrials.gov) (NCT03924999) and available at https://clinicaltrials.gov/ct2/show/NCT03924999?term=lipedema&draw=2&rank=6.

Pneumatic soft actuators (PSAs) are components that produce predesigned motion or force in different end-use devices. PSAs are lightweight, flexible, and compatible in human-machine interaction. The use of PSAs in compression therapy has proven promising in proactive pressure delivery with a wide range of dosages for treatment of chronic venous insufficiency and lymphedema. However, effective design and control of PSAs for dynamic pressure delivery have not been fully elaborated. The purpose of this study is to explore interactive working mechanisms between a PSA and lower limbs through establishing fluid-structure coupling models, an intermittent pneumatic compression (IPC) testing system, and conducting experimental validation. The developed IPC testing system consisted of a PSA unit (multichambered bladders laminated with an external textile shell), a pneumatic controller, and various real-time pressure monitoring sensors and accessory elements. The established coupling model characterized the dynamic response process with varying design parameters of the PSA unit, and demonstrated that the design of initial thickness, stiffness, and air mass flow of the PSA, as well as stiffness of limb tissues of the users, influenced PSA-lower limb interactions and resultant pressure dosages. The simulated results presented a favorable agreement with the experimental data collected by the IPC testing system. This study enhanced understanding of PSA-lower limb interactive working mechanisms and provided an evidence-based technical guidance for functional design of PSA. These results contribute to improving the efficacy of dynamic compression therapy for promotion of venous hemodynamics and user compliance in practice.

Background: Linforoll is a device composed of handpiece with roller and pressure sensor connected wireless to the computer displaying the pressure curve of the applied force. In a previous study, we proved it to regulate the applied force according to the hydromechanic conditions of the massaged tissues. Standardization of massage based on applied force was repeatable in the same patient; it decreased limb volume and provided evident increase in tissue elasticity. Methods and Results: In this study, we measured additional parameters useful for the understanding of tissue and fluid events and approval of the device for general practice. These were skin stiffness, subcutaneous tissue stiffness independent of skin, skin water concentration, changes in skin temperature, skin capillary blood flow, subcutaneous tissue fluid pressure, volume of the moved edema fluid, and visualization of movement on indocyanine green (ICG) lymphography. Measurements were done before and during the massage. The data were obtained from a group of 20 patients with obstructive lymphedema of lower limbs during the Linforoll massage. There was a lack of significant changes in skin stiffness, skin water concentration, skin surface temperature, and capillary blood flow, but evident increase in the subcutaneous tissue elasticity (tonometry) and lymphography-shown flow of the edema fluid. Conclusions: The skin tissue hydromechanic parameters remained normal proving lack of destructive changes under high massaging pressures. The obtained data evidently show that not the skin but the subcutis accumulated edema fluid that can successfully be moved proximally under pressures of 80-120 mmHg.

Background: Evaluation of intermittent pneumatic compression (IPC) in lymphedema is classically based on measurements of circumferences and volume of the edematous limb. However, although important, it provides only a general information without insight into what proceeds under the skin with respect to hydromechanical and structural changes., Aim and Methods: We present the multimodal evaluation of the effectiveness of IPC device in limb edema by measuring tissue stiffness, fluid pressure, and flow volume, and lymphoscintigraphic and near-infrared fluorescence (NIRF) indocyanine green (ICG) lymphography imaging of edema fluid movement, before and after one 45-60 minute compression cycle in over 50 patients with lymphedema stage II and III., Results: (1) Tissue fluid pressures were lower than those applied by IPC device. (2) The higher the applied compression force, the larger the flow volume. (3) Skin stiffness (superficial tonometry) decreased mainly in the calf, whereas, subcutaneous tissue (deep tonometry) was observed at all limb levels. (4) Skin water concentration (dielectric constant) was only insignificantly decreased, but subcutaneous extracellular water (bioimpedance Ldex index, fluid movement force test) was effectively moved away to limb proximal regions. (5) Imaging tissue (edema) fluid flow pathways on lymphoscintigram and real-time flow on NIRF ICG video could be observed and were evaluated semiquantitatively., Conclusions: Adjustment of compression parameters to tissue stiffness, fluid accumulation volumes, and fluid movement ability (hydraulic conductivity of tissues) at various limb levels is indispensable for effective therapy. Redesigning of compression devices will be needed to enable applying differentiated compression pressures and prolonged timings at various limb levels.

Background: Pneumatic compression has been used for more than 40 years in the management of lymphedema (LE). Modes of application have evolved with little consensus regarding optimal treatment parameters or dosage. The aim of this systematic review was to report the evidence for dosage of intermittent pneumatic compression (IPC) for people with LE and, particularly, that for upper versus lower limbs or child versus adult dosage., Methods: Medline, Embase, CINAHL, PubMed, and Scopus were searched with terms, including LE and IPC devices, with no restriction on time. Other materials searched included reference lists of included articles., Study Selections: Systematic review registration: PROSPERO ID: CRD42017054338. Studies were assessed according to PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines and were excluded if they were not in English, not human, had physiological outcomes, or studied IPC in combination with other therapies. Quality appraisal, using the McMaster University Critical Review Tool, was undertaken by two researchers with differences resolved by a third. One hundred twenty-two full-text studies were screened for eligibility., Results: Sixteen met inclusion criteria for final analysis. Of these, four were reported separately due to concurrent use of compression garments during the study period. One randomized controlled trial met the requirements for a level II (National Health and Medical Research Council) rating; the remainder were level III-2 and below. Devices applying compression via multichamber sleeves were more commonly used in the past 20 years, with a trend toward lower pressures and shorter treatment times compared with earlier studies. Little evidence exists for application of specific dosage of IPC for children or a particular limb. New devices utilizing lower pressures support home use and self-management of LE., Conclusion: Low-level evidence of moderate quality shows significant outcomes achieved with dosage times of 45-60 minutes, applying pressures between 30 and 60 mmHg in sequential IPC programs. Methodological limitations in most studies suggest caution in drawing conclusions.

Background: The therapeutic intermittent pneumatic compression (IPC) pressures are usually set arbitrarily at levels between 40 and 60 mmHg. However, it is not known how much force has been transferred to edema fluid. There is a need to know how high edema fluid pressures should be generated to evacuate the stagnant fluid. The externally applied compression force dissipates in hard tissues and only a portion of it is conveyed to tissue fluid. Simultaneous measuring of compression force using deep tissue tonometry and recording edema fluid pressures under a tonometer would give hints of how high should therapist or patient set IPC pressures to mobilize fluid., Aim: (1) To simultaneously measure the applied tonometer force and the generated edema fluid pressures under the tonometer, (2) to plot tonometer force against fluid pressure data to create a correlation curve for setting pressure of IPC at levels initiating fluid flow, (3) to work out a formula for setting pressures in the pneumatic device for individual patient, based on tonometry, (4) to prove the value of formula on a cohort of patients treated with IPC., Methods: Deep tissue tonometry force and tissue fluid pressures under the tonometer indentor were measured in lower limbs in a group of 20 patients with lymphedema stages I-III., Results: (1) Deep tissue tonometry penetrating to a depth of 10 mm provided data on pressure generated in tissue fluid under the tonometer indentor. (2) Plotting the applied tonometer force against the tonometer-generated tissue fluid pressures revealed that force to reach the threshold of 30 mmHg fluid pressure necessary for initiation of flow should be >1000 g/sq. cm. (3) A formula, based on tonometry values, for setting ICP pressures at levels generating pressures for initiating edema fluid flow was worked out. (4) Usefulness of the formula for setting IPC at effective levels was proved on a cohort of patients., Conclusions: Deep tissue tonometry of limbs is useful for setting IPC devices at compression pressures for mobilizing edema fluid.

Purpose: We aimed to assess the improvement in stiffness in patients with postmastectomy lymphedema (PMLE) after intermittent pneumatic compression (IPC) using acoustic radiation force impulse (ARFI) imaging and evaluate the effects of different IPC pressures., Methods: We randomly assigned 45 patients with PMLE (stage II) to three groups based on the IPC pressure: 25, 35, and 45 mmHg. Patients received a single session of IPC for 30 minutes. We recorded the subcutaneous tissue thickness of the proximal upper limbs using ultrasonography and circumference of the upper limbs and stiffness using ARFI before and immediately after IPC., Results: Arm circumference and subcutaneous tissue thickness were significantly decreased after IPC in all groups. The shear wave velocity (SWV) decreased after IPC in all groups, but significantly decreased only in the 35 mmHg group. The subcutaneous tissue thickness and SWV in the 35 mmHg group were significantly decreased compared to the other groups., Conclusion: IPC can reduce stiffness and subcutaneous tissue thickness of the proximal upper arm in patients with PMLE. A pressure of 35 mmHg yields the largest improvement of stiffness; higher compression pressure did not yield any additional improvement.

Background: Intermittent pneumatic compression (IPC) is a widely used lymph drainage therapy that can be performed at home. However, the effectiveness of IPC for lymph drainage remains unclear. The aim of this study is to investigate the real-time change in the lymph flow velocity during IPC and consider which mode and pressure are best for treating lower limb lymphedema., Methods and Results: Eight lower left limbs of 8 healthy volunteers and 17 lower limbs of 15 secondary lymphedema patients were investigated. Indocyanine green lymphography was performed with the subject covered with a transparent six-chambered IPC garment. The IPC treatment was administered in several modes (sequential or nonsequential inflation mode, sequential or interrupted deflation mode, and under high or low pressure). Using a brightness intensity analysis software program, the real-time change in the fluorescence intensity during the treatment was recorded and graphed. The maximum inclination of the graph between 2 seconds in the inflation phase (SLOPE) and the mean SLOPE value of all subjects (average SLOPE) were calculated. The average SLOPEs of each mode of treatment were then compared. The average SLOPEs were also compared between patients with mild and moderate lymphedema. There were no significant differences among the SLOPEs in the healthy group. However, in the patient group, the average SLOPE was significantly higher in the sequential inflation mode as well as under high pressure than in the nonsequential inflation mode. On comparing the mild and moderate lymphedema groups, the average SLOPE tended to be higher in the mild group; however, the difference was not statistically significant., Conclusions: Sequential programs and high pressure resulted in a faster lymphatic flow than other modes. These results suggest that a greater treatment effect could be obtained by adjusting the mode of treatment and the pressure of IPC.

This article presents results of computer simulations of the hydro-mechanical processes in the lymphedematous tissue under stress of a single chamber of sleeve for pneumatic compression. The discussion was focused on parameters of compression as pressures and inflation times to squeeze out the mobile tissue fluid from the edematous tissue. Simulations have predicted that the process of squeezing of tissue fluid is strongly dependent on the pressure in chamber and time of its action. The simulations showed that the values of loads and time applied in currently used pneumatic compression systems are not sufficient to force complete outflow of mobile fluid and pressure dissipation in limb swollen soft tissues.

Background: The manual lymphatic drainage in lymphedema has proved to be successful; however, this method cannot be applied to millions of patients around the world. The only solution is to offer inexpensive, easily accessible mechanical devices for pneumatic compression (IPC). These devices should be designed on parameters of edema fluid hydromechanics. Recent data point to high pressures and long time of compression., Aim: To validate the effects of 3 years daily high pressure, long inflation time IPC therapy in terms of decrease of limb circumference/volume, tissue elasticity, histological changes, and incidental complications., Methods: A group of 18 patients with unilateral leg lymphedema stage II to IV was treated for a period of 3 years using an 8-chamber sleeve, sequential inflation of chambers to 100-120 mmHg for 50 sec (total 400 sec). Limb circumference and tissue tonicity were measured at monthly intervals. Correlation between decrease in calf and thigh circumference and increase in elasticity was done., Results: The treatment revealed durable permanent decrease of limb circumference and increased elasticity of tissues. The improvement was most expressed in the calf above the ankle and mid-calf. No complications as thigh ring or chronic genital edema were observed. There was no direct correlation between the decrease in limb circumference and increase in elasticity, most likely due to different mass of fibrous tissue., Conclusions: IPC takes over the permanently missing function of the obliterated lymphatics by squeezing edema tissue fluid to the regions with normal lymphatic drainage. The limb circumference is decreased or at least does not further increase, elasticity of tissue is increased and maintained. No complications in limb tissues were observed. The long-term, high pressure IPC, long inflation timed therapy can be safely be recommended to patients with lower limb lymphedema.

Unlabelled: Pneumatic compression of tissues with lymph stasis is, aside from the manual massage, a commonly used therapeutic modality in limb lymphedema. A number of pneumatic devices have been constructed. There is lack of reports of comparative studies determining inflation pressure levels, inflation/deflation cycle times, and total pumping times., Aim: We tried to answer the question how high compression pressure and how long compression timing should be applied to the limb soft tissues to reach tissue fluid (TF) head pressure above 30 mmHg, necessary to initiate proximal flow., Methods: TF pressures were measured subcutaneously during intermittent pneumatic compression in the lymphedematous limbs stage II to IV. Pressures of 50, 80, and 120 mmHg and timing 5, 20, and 50 sec were applied., Results: a) the TF head pressures were lower than those in inflated chambers, b) inflation time of 5 and 20 sec was not long enough to generate TF head pressures above 30 mmHg, even if the compression pressures were as high as 120 mmHg, c) the 50 sec timing allowed to reach head pressures above 30 mmHg; however, they remained always lower than in the compression chamber, d) TF head pressures differed at various levels of the limb depending on the soft tissue mass, e) deflation of the inflated whole sleeve for 5 and 20 sec was followed by high end pressures, whereas that of 50 sec brought about pressure drop to 0, facilitating refilling with TF of the distal parts of the massaged limb., Conclusions: Our observations point to the necessity of applying high pressures and compression times over 50 sec, to generate effective TF pressures and provide enough time for creating TF flow. Short inflation times generate TF pressures as in one-chamber devices that preclude its effectiveness compared to the multi-chamber devices.