Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline Pain at 3 months of therapy and one month and a half after treatment.
研究概览
简要总结
Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability to those who suffer it. Currently, other treatment resources are being implemented, such as aquatic therapy. This therapy seems to provide positive results in different dimensions of fibromyalgia.
The main objective of the study is to determine the effectiveness of a physical therapy program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction and improvement balance at the end of treatment and a month and a half later (follow-up).
The type of study is a randomized controlled opened trial. The sample is composed of 34 women with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2 groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will have two primary outcomes: Pain and balance. The intensity of pain will be assessed using the visual analog scale (VAS) and the pain threshold for each one of the 18 tender points will be assessed using a electronic algometer. Static balance will be evaluated with the Romberg's test and the dynamic balance with the Timed Up & Go test (TUG) and Berg Balance Scale. Both type of balance will be recorded in slow motion and then, will be analysed with a motion software. Secondary outcomes are: The impact of fibromyalgia on patient's lives, that will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR); the sleep quality, that will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI); the fatigue, that will be evaluated witn the "Multidimensional Fatigue Inventory" (MFI); the physical capacity, that will be measured with the "six minute walk test" (SMWT) and confidence in balance that will be assessed with the "Activities-specific Balance Confidence" scale (ABC).
Each intervention will last one hour and will be made 3 times a week for three months . It will consist of 4 sections: Warming, exercises for static and dynamic balance training, stretching and relaxation. Statistical analysis will be made using the Statistical Package for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the significance level set for all analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range between 35 and 64 years.
- •Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR) in 1990 and
- •Mark ≥ 4 on the Visual Analogue Scale (VAS).
- •Mark ≥ 5 on the Visual Analogue Scale for balance included in The Revised Fibromyalgia Impact Questionnaire (FIQR).
排除标准
- •History of severe trauma.
- •Neurological diseases (stroke, Parkinson's disease, dementia).
- •Frequent migraines.
- •Inflammatory rheumatic diseases.
- •People who have been treated in the past six months by traumatic injuries.
- •Being pregnant.
- •Visual or hearing deficits uncorrected.
- •Infectious diseases.
- •Severe cardiovascular disease.
- •People who do exercise regularly more than 20 minutes, more than 3 times a week in the past 3 months.
结局指标
主要结局
Change from baseline Pain at 3 months of therapy and one month and a half after treatment.
时间窗: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Pain will be assessed using the visual analog scale (VAS).
Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment.
时间窗: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
It will be assessed using the Timed Up \& Go test (TUG), whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.
Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment.
时间窗: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
It will be evaluated with the Romberg's test, whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.
次要结局
- Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
- Change from baseline Physical Capacity at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
- Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
- Change from baseline Fatigue at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
- Change from baseline Pain Threshold for each one of the 18 tender points established at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
- Change from baseline Confidence in Balance at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
- Change from baseline Functional Independence to perform activities of daily living at 3 months of therapy and one month and a half after treatment.(It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).)
研究者
Sabela Rivas Neira, PhD
PhD
Universidade da Coruña