Fibromyalgia Clinical Trial
Official title:
Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia
Verified date | June 2016 |
Source | Universidade Federal de Sao Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2014 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Academia O2 | São Carlos | SP |
Lead Sponsor | Collaborator |
---|---|
Mariana Arias Avila |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Balance | Balance will be assessed by a force platform, in which patients will have to stand up still in some specific positions. | up to 5 months from the initial interview | No |
Other | Function | Funtion will be assessed as a composite measure that includes questionnaires to evaluate different varibales that could be related to function: Fibromyalgia Impact Questionnaire, SF-36, Beck Depression Inventory, Beck Anxiety Inventory and Pittsburgh Sleep Quality Index. | up to 5 months from the initial interview | No |
Other | Cardiorespiratory Status | Cardiorespiratory status will be assessed by the heart rate variability, the ECG and the ergometric test | up to 5 months from initial interview | No |
Primary | 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 | No |
Secondary | 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 | No |
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