跳至主要内容
临床试验/NCT02859168
NCT02859168已完成不适用

Randomized, Single-blind, Placebo-controlled Cross-over Design of Myofascial Induction and Placebo Electrotherapy in Breast Cancer Survivors

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Visual Analogue Scale (VAS). Change scores

研究概览

简要总结

The purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

详细描述

Background: To investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

Methods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant therapy except hormonal treatment. The study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical goniometry for range of motion, Profile of Mood States for psychological distress and Attitudes Toward Massage Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • had a diagnosis of breast cancer (cancer stage I-IIIA)
  • was between the ages of 25 and 65
  • had completed adjuvant therapy except hormonal treatment

排除标准

  • had cancer recurrence

结局指标

主要结局

Visual Analogue Scale (VAS). Change scores

时间窗: A wash-up period of 4 weeks between the 2 sessions was established

A numerical rating scale that contains scores in the range of 0 to 10 (0 = 'no pain/anxiety'; 10 = 'worst imaginable pain/anxiety level'). Participants must mark the level of pain that they feel at that moment in the cervical-arm area and use the scale to indicate their anxiety level.

次要结局

  • Profile of Mood States (POMS). Change scores(A wash-up period of 4 weeks between the 2 sessions was established)
  • Goniometry shoulder. Change scores(A wash-up period of 4 weeks between the 2 sessions was established)
  • Goniometry cervical. Change scores(A wash-up period of 4 weeks between the 2 sessions was established)
  • Attitudes toward massage (ATOM) scale(Covariates)

研究者

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

Manuel Arroyo Morales

PhD

Universidad de Granada

研究点 (2)

Loading locations...

相似试验