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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydrotherapy
Sponsored by
Mariana Arias Avila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Kinematics, Fibromyalgia, Physical Therapy, 3D Kinematics, Heart Rate Frequency, Hydrotherapy

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Academia O2

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hidrotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

3D Kinematics and electromyography
3D kinematics and electromyography will be evaluated with Flock of Birds, Motion Monitor Software and Delsys EMG Device

Full Information

First Posted
April 17, 2013
Last Updated
June 23, 2016
Sponsor
Mariana Arias Avila
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1. Study Identification

Unique Protocol Identification Number
NCT01839305
Brief Title
Effects of Hydrotherapy on Physical Function and Quality of Life of Women With Fibromyalgia
Official Title
Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mariana Arias Avila

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Kinematics, Fibromyalgia, Physical Therapy, 3D Kinematics, Heart Rate Frequency, Hydrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hidrotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Hydrotherapy
Intervention Description
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 Measure Information:
Title
Pain
Description
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
Secondary Outcome Measure Information:
Title
3D Kinematics and electromyography
Description
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
Other Pre-specified Outcome Measures:
Title
Balance
Description
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
Title
Function
Description
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 the initial interview
Title
Cardiorespiratory Status
Description
Cardiorespiratory status will be assessed by the heart rate variability, the ECG and the ergometric test
Time Frame
up to 5 months from initial interview

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania F Salvini, PhD
Organizational Affiliation
UFSCar
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antonio Roberto Zamunér, MSc
Organizational Affiliation
UFSCar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah C Trevisan, MSc
Organizational Affiliation
UFSCar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ester Silva, PhD
Organizational Affiliation
UFSCar
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paula R Camargo, PhD
Organizational Affiliation
UFSCar
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia Driusso, PhD
Organizational Affiliation
UFSCar
Official's Role
Study Chair
Facility Information:
Facility Name
Academia O2
City
São Carlos
State/Province
SP
ZIP/Postal Code
13562-003
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25786047
Citation
Zamuner AR, Andrade CP, Forti M, Marchi A, Milan J, Avila MA, Catai AM, Porta A, Silva E. Effects of a hydrotherapy programme on symbolic and complexity dynamics of heart rate variability and aerobic capacity in fibromyalgia patients. Clin Exp Rheumatol. 2015 Jan-Feb;33(1 Suppl 88):S73-81. Epub 2015 Mar 18.
Results Reference
derived

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

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