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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 17, 2013
First Posted Date  ICMJE April 24, 2013
Last Update Posted Date June 24, 2016
Study Start Date  ICMJE July 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01839305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 19, 2013)
  • 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.
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Hydrotherapy on Physical Function and Quality of Life of Women With Fibromyalgia
Official Title  ICMJE Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Other: Hydrotherapy
Publications * Zamunér 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
20
Original Actual Enrollment  ICMJE
 (submitted: April 19, 2013)
19
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01839305
Other Study ID Numbers  ICMJE 485/2011
FAPESP ( Other Grant/Funding Number: 2011/22122-5 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mariana Arias Avila, Universidade Federal de Sao Carlos
Study Sponsor  ICMJE Mariana Arias Avila
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Universidade Federal de Sao Carlos
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP