跳至主要内容
临床试验/NCT01839305
NCT01839305已完成不适用

Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia

Mariana Arias Avila1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月1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
发起方
入组人数
20
试验地点
1
主要终点
Pain

研究概览

简要总结

Fibromyalgia Syndrome (FS) is one condition that most affects functional performance, especially in women, due to alterations in the entire musculoskeletal system. Given that, Physical Therapy (PT) studies the human movement and its dysfunctions, and that FS, because of its complex chronic characteristic, impairs the affected individual's activities causing movement disorders, a PT professional must be part of the multidisciplinary team involved in the FS treatment. Nonetheless, as explained in the present proposal, several aspects still need clarification related to the PT role in this syndrome. Particularly, studies that analyze the biomechanical, sensorial and cardiorespiratory adaptations in individuals who undergo PT intervention still lack; those studies would contribute with scientific evidence to the clinical practice. According to recent systematic reviews, one of the most used therapies with positive effects on FS subjects is the hydrotherapy, which combines exercises and the water relaxing effects. Other alternative treatments have also been searched, in an attempt to decrease the painful picture presented, as the FS etiology and pathophysiology are not well known. The aim of this study is to evaluate the efficacy of different physical therapy resources in the FS, in two subprojects. The first will verify if hydrotherapy is effective in modifying movement variables (scapular kinematics and electromyography) and autonomic modulation. Other variables, such as pain level and quality of life in women with FS, will also be analyzed. The second study will evaluate the efficacy of the Shiatsu massage on pain, sleep quality, balance and quality of life of subjects with FS.

详细描述

Subjects were invited to take part in several assessments before starting the actual Hydrotherapy Treatment. These assessments were:

  1. Three-dimensional scapular evaluation
  2. Questionnaires (FIQ, SF-36, Beck Depression Inventory, Beck Anxiety Inventory, Pittsburgh Quality of Sleep Index)
  3. Pain (pressure pain threshold and trigger points) Subjects were evaluated 3 times one month before starting treatment, one time in the middle of treatment and after treatment completion.

Treatment lasted 16 weeks and consisted of 2 weekly 45' hydrotherapy sessions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •to have a clinical fibromyalgia diagnosis according to the 1990 ACR criteria
  • •to be aged from 30 to 60 years old.

排除标准

  • •Body Mass index >28kg/m²
  • •Cognitive deficits that prevented patients to understand the evaluation procedures
  • •Uncontrolled systemic illnesses (e.g. diabetes mellitus and systemic arterial hypertension)
  • •Neurological and musculoskeletal conditions that could have directly interfered in the evaluations, as paresis, important sensitive alterations, advanced joint diseases (e.g. arthroplasties or osteoarthritis)
  • •Infections
  • •Urinary incontinence
  • •Pregnancy

研究组 & 干预措施

Hidrotherapy

Experimental

Patients performed hydrotherapy 2 twice a week, for 16 weeks, to check if there was any effect on the outcome measures for women with fibromyalgia

干预措施: Hydrotherapy (Other)

结局指标

主要结局

Pain

时间窗: up to 5 months from the initial interview

Pain will be assessed as a composite measure through Visual Analogue Scale (VAS), Numerical Pain Rating Scale (NPRS), Myofascial Trigger Points (MTrPs) and Pressure Pain Threshold (PPT) on specific sites.

次要结局

  • 3D Kinematics and electromyography(up to 5 months from the initial interview)

研究者

发起方
Mariana Arias Avila
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mariana Arias Avila

MSc

Universidade Federal de Sao Carlos

研究点 (1)

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