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

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ClinicalTrials.gov Identifier: NCT01839305
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Mariana Arias Avila, Universidade Federal de Sao Carlos

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Hydrotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia
Study Start Date : July 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Hidrotherapy
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
Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks




Primary Outcome Measures :
  1. Pain [ 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.


Secondary Outcome Measures :
  1. 3D Kinematics and electromyography [ 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


Other Outcome Measures:
  1. Balance [ 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.

  2. Function [ 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.

  3. Cardiorespiratory Status [ 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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839305


Locations
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Brazil
Academia O2
São Carlos, SP, Brazil, 13562-003
Sponsors and Collaborators
Mariana Arias Avila
Investigators
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Study Director: Tania F Salvini, PhD UFSCar
Principal Investigator: Antonio Roberto Zamunér, MSc UFSCar
Principal Investigator: Deborah C Trevisan, MSc UFSCar
Study Chair: Ester Silva, PhD UFSCar
Study Chair: Paula R Camargo, PhD UFSCar
Study Chair: Patricia Driusso, PhD UFSCar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mariana Arias Avila, MSc, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01839305     History of Changes
Other Study ID Numbers: 485/2011
FAPESP ( Other Grant/Funding Number: 2011/22122-5 )
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mariana Arias Avila, Universidade Federal de Sao Carlos:
Kinematics
Fibromyalgia
Physical Therapy
3D Kinematics
Heart Rate Frequency
Hydrotherapy
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases