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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01839305
Enrollment
20
Registered
2013-04-24
Start date
2011-07-31
Completion date
2014-03-31
Last updated
2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Kinematics, Fibromyalgia, Physical Therapy, 3D Kinematics, Heart Rate Frequency, Hydrotherapy

Brief summary

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

Subjects were invited to take part in several assessments before starting the actual Hydrotherapy Treatment. These assessments were: 1. Three-dimensional scapular evaluation 2. Questionnaires (FIQ, SF-36, Beck Depression Inventory, Beck Anxiety Inventory, Pittsburgh Quality of Sleep Index) 3. 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.

Interventions

OTHERHydrotherapy

Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks

Sponsors

Mariana Arias Avila
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Painup to 5 months from the initial interviewPain 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.

Secondary

MeasureTime frameDescription
3D Kinematics and electromyographyup to 5 months from the initial interview3D kinematics and electromyography will be evaluated with Flock of Birds, Motion Monitor Software and Delsys EMG Device

Other

MeasureTime frameDescription
Balanceup to 5 months from the initial interviewBalance will be assessed by a force platform, in which patients will have to stand up still in some specific positions.
Functionup to 5 months from the initial interviewFuntion 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.
Cardiorespiratory Statusup to 5 months from initial interviewCardiorespiratory status will be assessed by the heart rate variability, the ECG and the ergometric test

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026