A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Romberg's Balance Test Modified Version
研究概览
简要总结
The objective of this study is to compare the effectiveness of two types of body vibration platform, one vertical and one rotational, through a 12-week training in patients with fibromyalgia.
详细描述
This is a single blind randomized controlled trial. Sixty patients of FM will be assigned randomly to 3 study groups: 20 patients will be part of the vertical whole body vibration experimental group in the EG1, that will perform a neuromuscular treatment using the vertical whole body vibration platform, another 20 will constitute the rotational whole body vibration experimental group in the EG2, that will perform a neuromuscular treatment using the rotational whole body vibration platform, and another 20 will constitute the control group (CG). All these subjects will sign the corresponding informed consent for their participation in the study, according to the ethical criteria established in the Helsinki Declaration. The study will take place between January and December 2016. Three groups of variables were analyzed in the present study three times: before, after and follow-up after three months of the intervention.
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, Investigator)
盲法说明
In this clinical trial design strategy, the participants and the investigator do not know which participants have been assigned which interventions so there is a double-blind masking.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia
排除标准
- •History of severe trauma.
- •Severe disease that prevents supporting the program physical load.
- •Pregnancy.
- •Participation in a psychological or physical therapy program.
研究组 & 干预措施
Vertical whole body vibration platform.
Use of a rotational whole body vibration platform.
干预措施: Vertical whole body vibration (Device)
Rotational whole body vibration platform
Use of a rotational whole body vibration platform.
干预措施: Vertical whole body vibration (Device)
Control group
No intervention.
结局指标
主要结局
Romberg's Balance Test Modified Version
时间窗: 1 minute.
In the present study, we analyzed the oscillatory body movements during the test performance. Participants were situated below a cam situated above the ground and regulated to be placed at a mean distance of 50 cm. from the participant's head. They were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute.
Gait Task
时间窗: 5 minutes.
gait velocity (cm/sec)
Vibration Thresholds
时间窗: 20 minutes
Peripheral sensory function was evaluated by measuring vibration thresholds.
Pressure Pain Thresholds
时间窗: 20 minutes
Pressure stimuli were applied on epicondyles and index finger.
Six-minute Walking Test (6MWT)
时间窗: 6 minutes.
The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.
Visual Analogue Pain Scale (VAS)
时间窗: 5 minutes.
Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 10 minutes.
Fibromyalgia Impact Questionnaire (FIQ
Dynamometer
时间窗: 5 minutes.
A back muscle dynamometer was used to measure isometric back muscle strength.
Perceived Quality of Life Index
时间窗: 10 minutes.
The Quality of Life Index (QLI-Sp) is a self-report questionnaire that measures perceived health-related quality of life that includes 10 items or domains: physical wellbeing, psychological/emotional well-being, selfcare and independent functioning, occupational functioning,interpersonal functioning, social-emotional support, community and services support, personal fulfilment, spiritual fulfilment, and overall quality of life.
次要结局
未报告次要终点