Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Intervention / Treatment
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* Procedure: Aquatic therapy
* Procedure: Land-based therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female. Age range between 35 and 64 years. Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR) in 1990 and 2010. 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic therapy<br>Aquatic therapy is the experimental group. This therapy will take place in a warm pool which is located in Rialta's Sports Complex. Aquatic therapy session will be conducted by the main researcher with the help of an assistant. Because the number of patients (n=17), they will be subdivided into two subgroups of 8 and 9 people respectively in order to ensure the safety and care of patients. The intervention will last for one hour: Warming (15 minutes); exercises to train the static and dynamic balance (25 minutes); stretching (10 minutes); relaxation (10 minutes). Over 12 weeks of treatment, difficulty in performing exercises to train balance will increase progressively. | Procedure: Aquatic therapy<br>* Pool material is contributed by Maria José Jove Foundation. The exercises that will be made during treatment, are designed and developed to improve core muscles and, in this way, improve postural balance.<br>|
| Other: Land-based therapy<br>The description is the same as aquatic therapy. The difference is land-based therapy sessions will be made at Faculty of Physiotherapy at University of A Coruña. | Procedure: Land-based therapy<br>* The material is contributed by Faculty of Physiotherapy at University of A Coruña. The exercises that will be made during treatment, are designed and developed to improve core muscles and, in this way, improve postural balance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Pain at 3 months of therapy and one month and a half after treatment. | Pain will be assessed using the visual analog scale (VAS). | It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). | 
| Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment. | 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. | It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). | 
| Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment. | 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. | It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment. | It will be measured with the Revised Fibromyalgia Impact Questionnaire (FIQR). | It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). | 
| Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment. | It will be assessed with the Pittsburgh Sleep Quality Index (PSQI). | 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 evaluated with the Multidimensional Fatigue Inventory (MFI). | 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 with the six minute walk test (SMWT). | 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 assessed with the Activities-specific Balance Confidence scale (ABC). | 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 assessed using an electronic algometer. | 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 assessed using the Berg Balance Scale. | It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Pain, Postural balance, Physical therapy, Aquatic therapy