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临床试验/NCT03182881
NCT03182881已完成不适用

Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery In Women Undergoing Conservative Surgery and Radiotherapy. Randomized Clinical Trial

University of Valencia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Pain

研究概览

简要总结

Objective. To compare the effectiveness of myofascial therapy against manual lymphatic drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in women who survived breast cancer.

Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13 patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual lymphatic drainage.

Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range, shoulder functionality using the DASH questionnaire, quality of life assessed using the FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this was assessed before and after treatment, and one month later as follow-up.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between the ages of 30 and 60 diagnosed with breast cancer undergoing conservative / partial surgery.
  • Without lymphedema or mild lymphedema.
  • They must have finished the coadjuvant treatment.

排除标准

  • Women with muscle or tendon lesions in the arm.
  • Kin disorders or circulatory pathology.
  • Chemotherapy or radiotherapy.
  • Surgical history in the area are excluded from the study.

研究组 & 干预措施

Miofascial-reléase

Experimental

Myofascial Release (MR), with the purpose of releasing fascial restriction zones and major fibrosis (thoraco-brachial) caused by restriction after CM tto. IM therapy was applied to the affected area. The position of the patient was identical during both treatment sessions.

干预措施: Myofascial Release (Other)

Manual Lymphatic Drainage (MLD)

Active Comparator

It was applied following the Leduc method with the patient in a supine position with 30º elevation of the arm and very superficial and smooth maneuvers were performed in the axillary lymph nodes, in the chest region and in the arm with the same sequence as Guerero et al. The objective of the application in our study is to obtain a beneficial treatment for the patient since it produces an increase of blood and lymphatic circulation, with positive effects on the peripheral vegetative nervous system.

干预措施: Lymphatic Drainage (Other)

结局指标

主要结局

Pain

时间窗: 2 months

The Visual Analog Scale (EVA) was used. This scale consists of marking on a horizontal line of 10 cm in length VAS is a 10-point rating scale (0 = absolute discomfort and 10 = full comfort).

次要结局

  • Functional Assessment of Cancer Therapy Breast(2 months)
  • Disabilities of the Arm, Shoulder and Hand (DASH)(2 months)
  • Joint mobility(2 months)
  • Depressive state(2 months)

研究者

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

GEMMA V ESPÍ LÓPEZ, PhD

Dr

University of Valencia

研究点 (2)

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