With chronic obstructive derangement in the regional lymphatic circulation, an edematous state ensues that is characterized, over time, by chronic architectural alterations in the skin and supporting tissues [1
]. Lymphedematous tissues are conceptualized to have a lower oxygen content, a greater distance between lymph vessels induced by the interstitial fluid accumulation, impaired lymphatic clearance, and depressed macrophage function, endowing these patients with an increased risk of soft tissue infection [25
]. Once established, lymphedema has an inexorable tendency to progress. The concerted effects of increased interstitial fluid volume and chronic fibrotic changes expose these patients to substantial functional impairment, coupled with the psychosocial dysfunction that emanates from the chronic disease state and the associated impairment in body image and self-esteem [26
Although the deleterious consequences of chronic lymphedema can be substantially reduced by effective physical management [10
], the long-term impact of chronic decongestive physiotherapy upon lymphedema has not yet been optimized. While initial, intensive physiotherapeutic interventions can effectively minimize volume changes in the edematous limb, concerted self-management is required to maintain therapeutic benefits. Patients can effectively be taught to self-administer manual lymphatic drainage, but a gradual diminution in the magnitude of the initial therapeutic benefit is predictable [16
]. It is likely that this phenomenon is related to some combined effect of patient inefficiency and a time-dependent reduction in patient compliance with self-management techniques. Adjunctive therapies, like intermittent pneumatic compression, have proven benefit [29
], but may compound patient difficulty with compliance, since, of necessity, these adjunctive treatment measures lengthen the daily requirement for self-management.
In an attempt to improve the impact of maintenance self-management strategies on chronic lymphedema, we have undertaken the current study to investigate the relative efficacy of the Flexitouch™ when compared with a standard treatment approach (self-administered massage). The biodesign of the device and its impact on the disease state confer some distinct theoretical advantages. Because the Flexitouch™ is bioengineered to closely simulate the effects of correctly performed simple manual lymphatic massage, it should theoretically minimize the effect of improper or inadequate technique upon the treatment outcome. Furthermore, because the device emphasizes comfort and minimizes the active participation of the patient, it should, in principle, optimize compliance.
Indeed, our observations suggest that, even in short-term use, the device confers therapeutic benefit over that which can be attained through standard therapy. In addition to the demonstrable small, but significant, improvement in edema volume, the statistically significant reduction in body weight that accompanies the use of the Flexitouch™ serves as an independent confirmation of the added efficacy of this approach for the reduction of edema volume. While the magnitude of weight loss cannot be entirely explained by the quantitative reduction in limb edema volume, the concurrent changes seem to validate the beneficial impact of the Flexitouch™. The phenomenon of weight loss certainly bears additional investigation in larger numbers of patients. The current study was not designed to specifically address this response and, therefore, additional study with control of relevant variables during the treatment phase, such as fluid intake, diet, exercise, and medications, will be required to validate the observed phenomenon and to address the potential mechanisms of the therapeutic benefit.
The current, pilot study is limited chiefly by the small sample size and short duration of the therapeutic intervention. The positive results suggest that further investigation will be useful. When observed in larger cohorts of patients, with treatment phases sustained over longer intervals, it can be anticipated that even more substantial volume benefits might be demonstrable. In addition, quality-life-indicators should theoretically have the capacity to detect any favorable impact of streamlined therapy upon perceptions of the disease state. Finally, it will be desirable to attempt to demonstrate the theoretical favorable impact of this intervention upon tissue architecture and other chronic structural consequences of lymphedema. It is well-recognized that lymphedema, with chronicity, occasions the secondary proliferation of fibroblasts, keratinocytes, and adipocytes, the accumulation of collagen, and the destruction of elastin fibers within the skin [30
]. It has been hypothesized that effective physiotherapy of lymphedema can diminish or eliminate these otherwise inexorable consequences. It is relevant that, in a recent study of the effect of therapeutic intervention upon lymphatic filariasis, the institution of even simple measures to reduce edema possessed the capacity to ameliorate the histopathological manifestations of chronic inflammation and fibrosis in punch biopsies of the skin [31
]. While such direct histological confirmation may not be as readily derived from a breast cancer-associated lymphedema population, future, more extensive studies of the therapeutic potential of the Flexitouch™ might realistically incorporate other, more indirect attempts to document an ameliorative effect upon tissue architecture. Furthermore, evaluation of patients during more protracted use of the device, if it indeed enhances treatment outcome while minimizing the incursion of self-management upon the activities of daily living, would be predicted to disclose an improvement in perceptions of psychosocial and physical well-being. The aggregate benefits to be derived from this device will then require consideration in relationship to the retail cost of this device as it is currently marketed (unilateral garment, US $10,800; bilateral garment, US $12,400).