Effects of Hydrotherapy on Physical Function and Quality of Life of Women With Fibromyalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects were invited to take part in several assessments before starting the actual Hydrotherapy Treatment. These assessments were: Three-dimensional scapular evaluation Questionnaires (FIQ, SF-36, Beck Depression Inventory, Beck Anxiety Inventory, Pittsburgh Quality of Sleep Index) 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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Hydrotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: to have a clinical fibromyalgia diagnosis according to the 1990 ACR criteria to be aged from 30 to 60 years old. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hidrotherapy<br>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 | Other: Hydrotherapy<br>* Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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. | up to 5 months from the initial interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D Kinematics and electromyography | 3D kinematics and electromyography will be evaluated with Flock of Birds, Motion Monitor Software and Delsys EMG Device | up to 5 months from the initial interview | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kinematics, Fibromyalgia, Physical Therapy, 3D Kinematics, Heart Rate Frequency, Hydrotherapy