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临床试验/NCT04296929
NCT04296929Unknown不适用

The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema Patients

Hacettepe University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Two-point discrimination

研究概览

简要总结

The aim of this study was to determine the effect of complex decongestive physiotherapy in women with unilateral breast cancer-related lymphedema on sensory parameters.

详细描述

Although there are a limited number of studies in the literature on disorders of sensory functions seen after breast cancer treatments, sensory disorders that may be seen in lymphedema associated with breast cancer were evaluated in only 2 studies published in 1979 and 2006. Although these studies are not sufficient in terms of study design, they only include Semmes-Weinstein monofilaments and two-point discrimination tests and hand evaluations. Ganel et al. Reported that approximately 50% of the patients they included in the study found that varying degrees of lymphedema developed in the upper extremity, and the median nerve compression in the brachial plexus and carpal tunnel was significantly higher in these patients. They did not find a direct correlation with radiotherapy in patients with nerve compression. They therefore stated that nerve compression may be associated with lymphedema or fibroblast infiltration. According to this study, lymphedema may also be a risk factor in post mastectomy problems such as brachial plexus and carpal tunnel syndrome. Greve et al. reported that lymphedema may cause a decrease in sensory functions in patients who were evaluated with monofilaments in their studies on the effect of lymphedema on sensory functions after mastectomy (Ganel 1979, Greeve 2006).

Complex Decongestive Physiotherapy was developed by Földi in the 1980s in Germany to reduce limb volume, preserve skin health, lymph transport stimulation and reabsorption of residual interstitial proteins. Complex Decongestive Physiotherapy is a treatment method consisting of four main elements and two phases. The four main elements of the first phase of complex decongestive physiotherapy; includes manual lymphatic drainage, skin care, compression therapy and remedial exercises. After the edema is reduced, phase II is passed. This phase includes self-drainage, skin care, personalized compression socks and remedial exercises. In lymphedema, protein-rich fluid accumulates in the subcutaneous tissue for a long time, disrupting natural skin elasticity over time. With Complex Decongestive Physiotherapy, edema reduction up to 65% can be achieved, functional loss, fibrotic changes, and cosmetic problems, which are the secondary problems caused by lymphedema, can be observed.

Increased interstitial fluid in lymphedema associated with breast cancer can cause local sensory loss due to compression of peripheral nerves. Dermal thickness increase due to lymphedema and biomechanical changes in viscoelasticity can cause various changes on sensory functions. Therefore, quantitative evaluation of the sensory system can be an effective method to determine the injury risk factor of the lymphedema region in the event of an existing sensory dysfunction. However, although the effects of Complex Decongestive Physiotherapy on edema reduction, skin thickness and elasticity are mentioned, its effect on sensory functions is unknown.

Complex Decongestive Physiotherapy will be applied to patients for a total of 3 weeks, 5 days a week within the scope of this study.

The assessments will be performed before treatment and at the end of three weeks treatment period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of lymphedema disease
  • Ages between 18-80 years old,
  • 2 cm difference between the affected and unaffected arms in women with breast cancer related lymphedema,
  • At least 12 months after breast cancer treatments end and
  • Who are agreed to participate in the study.

排除标准

  • Women with active infection,
  • deep vein thrombosis/thrombophlebitis,
  • cardiac edema,
  • peripheral artery disease,
  • kidney, lung disease,
  • primary lymphedema,
  • peripheral upper limb nerve injury,
  • any surgery other than breast cancer surgeries,
  • existing shoulder, elbow, wrist, hand pathologies,
  • cooperation problems,
  • neurological disease,
  • mental illness, diabetes mellitus,
  • smoking and patients with open wounds on the upper limb.

结局指标

主要结局

Two-point discrimination

时间窗: Change from baseline two-point discrimination at 3 weeks

Assessment of two-point discrimination at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an esthesiometer in women with breast cancer related lymphedema.

Pressure pain threshold

时间窗: Change from baseline pressure pain threshold at 3 weeks

Assessment of pressure pain threshold at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an algometer in women with breast cancer related lymphedema.

Touching sensation

时间窗: Change from Baseline touching sensation at 3 weeks

Assessment of touching sensation at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with Semmes-Weinstein Monofilaments in women with breast cancer related lymphedema.

次要结局

  • Vibration sensation(Change from baseline vibration sensation at 3 weeks)
  • Ultrasonographic Imaging(Change from baseline ultrasonographic imaging at 3 weeks.)
  • Environmental measurement(Change from baseline environmental measurement at 3 weeks.)
  • Lymphedema Life Impact Scale(Change from baseline Lymphedema Life Impact Scale at 3 weeks.)
  • Hot / Cold Sensory Test(Change from baseline Hot/Cold sensory Test at 3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine BARAN

Research Assistant, Physical Therapist, Master of Science

Hacettepe University

研究点 (2)

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