Academia O2
São Carlos, São Paulo, 13562-003, Brazil
NCT Number: NCT01839305
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.
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Notify Me30 year–60 year
Female
Interventional
Not applicable
São Carlos, São Paulo, 13562-003, Brazil
Subjects were invited to take part in several assessments before starting the actual Hydrotherapy Treatment. These assessments were:
Treatment lasted 16 weeks and consisted of 2 weekly 45' hydrotherapy sessions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks
Time frame: up to 5 months from the initial interview
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.
Time frame: up to 5 months from the initial interview
3D kinematics and electromyography will be evaluated with Flock of Birds, Motion Monitor Software and Delsys EMG Device
Time frame: up to 5 months from the initial interview
Balance will be assessed by a force platform, in which patients will have to stand up still in some specific positions.
Time frame: up to 5 months from the initial interview
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.
Time frame: up to 5 months from initial interview
Cardiorespiratory status will be assessed by the heart rate variability, the ECG and the ergometric test
Mariana Arias Avila
Other
Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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