Completed Studies
Title: "Home Based Lymphedema Treatment in Patients With and Without Cancer-Related Lymphedema"
Authors: Sheila H. Ridner, PhD, RN (Vanderbilt University School of Nursing); Elizabeth McMahon, PhD (Kaiser Permanente HMO); Mary S. Dietrich, PhD (Vanderbilt University School of Nursing); Sunday Hoy, Esq. (Tactile Systems Technology Inc.); Oncology Nursing Forum. July 2008; 35(4): 671-680.
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Abstract: This study compared treatment protocol adherence, satisfaction, and perceived change in emotional and functional status between lymphedema patients with and without cancer using the home-based Flexitouch system for lymphedema self-care. A pre-therapy survey was completed before use of the Flexitouch system. Participants received in-home education about device use, safety precautions, and their therapy protocol. A post-therapy survey was completed during the home maintenance phase of the patient’s care.
Results: 90% of participants were satisfied with the Flexitouch system. 95% of participants reported successful limb volume outcomes. Participants also experienced significant improvements in physical and emotional status.
Conclusion: Overall, this study suggests that patients using the Flexitouch system are satisfied with the device and perceive it as beneficial in management of their lymphedema.
Title: "A Pilot, Prospective Evaluation of a Novel Alternative Maintenance Therapy of Breast Cancer-Associated Lymphedema"
Authors: Olivia Wilburn, Paul Wilburn and Stanley G. Rockson
Read study: http://www.biomedcentral.com/content/pdf/1471-2407-6-84.pdf
Abstract: Prospective investigations of complete decongestive lymphatic physiotherapy (CDPT), including manual lymphatic drainage (MLD), have validated the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema. However, CDPT demands substantial time and effort from patients to maintain these benefits; the treatments are not always well-accepted, and patients may suffer from a deterioration in quality-of-life or a time-dependent loss of initial treatment benefits. A new device designed for home use by the patient, the Flexitouch® system, has been developed to mechanically simulate MLD. We have undertaken a prospective, randomized, crossover study of the efficacy of the Flexitouch system, when compared to massage, in the self-administered maintenance therapy of lymphedema.
Results: Statistical analysis disclosed that the order of treatment had no outcome influence, permitting 10 comparisons within each treatment group. Post-treatment arm volume reduced significantly after the Flexitouch system, but not after self-administered massage. The patients' mean weight decreased significantly with Flexitouch™ use, but not with massage. The device was apparently well-tolerated and accepted by patients. Serial SF-36 administration showed no deterioration in physical or psychosocial scores compared to baseline measurements; there were no statistical differences in scores when the two treatment modalities were compared.
Conclusion: This short-term prospective evaluation of the Flexitouch system suggests that the device may provide better maintenance edema control than self-administered massage in breast cancer-associated lymphedema. The apparent ease of use and reliability of response to the device suggest that further broad-scale testing is warranted.
Title: “Interface Pressures Produced by Two Different Types of Lymphedema Therapy Devices”
Authors: Harvey N. Mayrovitz, PhD; Physical Therapy. October 2007; 87(10):1379-1388.
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Abstract: Sequential compression is used to manage lymphedema, but little is known about pressures delivered to the therapeutic targets. This study characterized actual pressures delivered by a traditional compression pump (Lympha Press [LP]) and one using an alternate compression pattern (Flexitouch [FT]).
Methods: Pressure-time along the forearm was measured using a 256–pressure sensor array during the pressure cycling of each device. Device assessments were separated by at least 48 hours.
Results: Pressure patterns and magnitudes produced by the 2 devices differed considerably. The FT pressure pattern displayed a rapid rise and fall, progressing from the wrist toward the elbow. The LP pressure rose slower and was sustained at a higher level during its inflation cycle. Pressures delivered with the LP were significantly greater than those delivered with the FT.
Conclusion: Pressures delivered with the LP were significantly greater (mean 32.6 ± 6.5 mmHg) than those delivered with the FT (mean 9.0 ± 4.2 mmHg).
Title: “Lymph Movement Accompanying Sequential Compression Therapy Assessed by Lymphoscintigraphy in a Patient with Lower Extremity Lymphedema”
Authors: Harvey N. Mayrovitz, PhD, and Sharon de Wit, MD
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Abstract: A significant aspect of treating lymphedema is the promotion of effective movement of accumulated lymphatic fluid. One well accepted measure of the rate of lymph fluid movement is derived from observed transit time of an injected radionuclide using the method of lymphoscintigraphy.
The purpose of this case study was to evaluate the impact of the Flexitouch system on the movement of lymph fluid in a patient with long-standing lower extremity lymphedema using lymphoscintigraphy. The subject underwent a series of three lymphoscintigraphy scans: the first at baseline; the second with the device on and functioning; the third following 28 days of daily usage of the device.
The results demonstrated improved clearance rates as measured by the arrival time of the tracer at the inguinal lymph nodes both during Flexitouch system usage and after ongoing daily usage. This data suggests the potentially important role of the Flexitouch system in long-term management of lymphedema.
Title: “Breast Cancer Related Lymphedema – The Flexitouch System as an Adjuvant to Maintenance Therapy”
Authors: Sandra G. Terrazas, PT, CWS, CLT-LANA
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Abstract: It is estimated that as many as 35 percent of breast cancer survivors will develop arm lymphedema as a result of axillary dissection or nodal radiation therapy for treatment of their breast cancer. Lymphedema can develop anytime, even several years after the damage to the lymphatic system occurred. Lymphedema can be treated and controlled, but not cured. If left untreated or poorly treated, lymphedema will progress and chronic inflammatory changes such as fibrosis and skin breakdown can occur. Recurrent infections and wounds that are difficult to treat may also develop. Lymphedema is usually treated with complete decongestive therapy (CDT). The components of CDT are manual lymphatic drainage (MLD), multilayered compression bandaging, exercise to promote lymph drainage, and skin care. Patients are instructed in the techniques of self-MLD for long-term home management of breast cancer related lymphedema. Self MLD is a difficult regimen for breast cancer survivors as they may have limited range of motion on their affected side, making them unable to reach areas that should be treated. In addition, the techniques of MLD are precise and may be difficult to successfully master. The Flexitouch system is a replacement for MLD in the home and is intended to extend the benefits of in-clinic MLD to the home as part of continued lymphedema therapy maintenance. As with MLD, preparation therapy initiates at the trunk via specially designed trunk and chest garments. Therapy then progresses to a drainage phase with an emphasis on the affected limb as well as the chest and trunk.
This eight week study was intended to demonstrate the use of the Flexitouch system as an adjuvant for long-term home management of breast cancer related lymphedema. In this study, two patients were monitored weekly for eight weeks after initiating twice daily use of the Flexitouch system. Outcomes evaluated included limb volume changes and clinical observation of skin integrity. In addition, functional status and dexterity were measured by evaluating fine motor movements. The effectiveness of this device as an adjuvant to maintenance home therapy is demonstrated in two patients. One patient maintained the limb girth similar to in-clinic therapy. Also, skin fibrosis was reduced and dexterity and fine motor skill improved resulting in a significant quality of life gain. The patient was able to return to some activities that had been stopped due to limitations in motion and dexterity. The second patient also demonstrated significant gains in limb volume reduction, and improvements in fibrosis, limb function, and dexterity. This subject also reported improved ability to perform her job. Unfortunately, the treatment was interrupted for four days by a bout of cellulitis. The infection was not attributable to use of the device. While the interruption likely affected continued progress, after reinstituting treatment, limb measurements returned to baseline by the end of week eight. In conclusion, patients’ lymphedema was controlled, their symptoms alleviated, and their quality of life improved following use of the Flexitouch system. These outcomes demonstrate that the Flexitouch system should be considered as part of home management for lymphedema patients.
Title: “A Case Series – Wound Healing Utilizing Automated Lymphedema Therapy”
Author: Caren Betz, PT, CWS
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Abstract: Edema is recognized as an inhibitor to wound healing. This case series evaluates use of the Flexitouch system as an adjunct to standard wound healing care to determine if device usage augmented healing time. It was hypothesized that the addition of this device would decrease length of treatment/time to closure, cost of providing care, and increase patient satisfaction with outcome.
Three individuals with lower extremity venous stasis wounds and one individual with a trunk wound were evaluated. All patients were referred for outpatient wound care with non-healing wounds as primary diagnosis. All patients had edema or lymphedema as a secondary diagnosis. Wound care was initiated and included irrigation, selective debridement of nonvitalized tissue, and dressing choice to promote a moist healing environment.
Each individual exhibited marked improvement at the wound site after treatment with the device where such progress had not occurred previously. Outcomes observed included expedited wound closure or reduction of wound size accompanied by reduction in edema. The device was well tolerated. These results suggest that this device may provide a new therapeutic option in wound healing.