Prospective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema

Stanford University Institutional Review Board (USA)0 个研究点目标入组 0 人开始时间: 2005年5月11日最近更新: 2017年10月30日

适应症

试验速览

暂无简介。

•Patients with lymphoedema of the upper extremity after surgical and/or radiotherapeutic interventions for breast carcinoma were eligible for enrollment. Recruitment was undertaken from the population of patients who presented to the Stanford Center for Lymphatic and Venous Disorders.
•To be eligible for enrollment, a subject was required to have evidence of unilateral, breast
•cancer-associated lymphoedema, with an increase of at least 10% in the measured volume of the affected arm when compared with the contralateral, normal limb. All subjects were required to have completed an initial treatment phase of limb volume reduction through intensive decongestive physiotherapy administered by a trained physiotherapist. A minimum of 30 days must have elapsed following the completion of initial treatment, which was required to include instruction in self-administered, maintenance manual
•lymphatic drainage (MLD) and the subsequent use of a properly fitted compression garment.

•Exclusion criteria included the presence of any of the following: bilateral lymphoedema of the upper extremity; active cancer; active infection; clinical evidence of venous obstruction or active thrombophlebitis; pulmonary oedema; congestive heart failure; a history of pulmonary embolism; or the presence of any other relative contraindication to
•the use of the lymphedema treatment modalities employed in this investigation.

发起方

Stanford University Institutional Review Board (USA)