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

NCT01839305 | Completed

• 2 other identifiers: 485/2011FAPESP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 5 months from the initial interview

Secondary Outcomes (1)

• 3D Kinematics and electromyography

  up to 5 months from the initial interview

Other Outcomes (3)

• Balance

  up to 5 months from the initial interview

• Function

  up to 5 months from the initial interview

• Cardiorespiratory Status

  up to 5 months from initial interview

Study Arms (1)

Hidrotherapy

EXPERIMENTAL

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

Interventions

Hydrotherapy OTHER

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

Hidrotherapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to have a clinical fibromyalgia diagnosis according to the 1990 ACR criteria
• to be aged from 30 to 60 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mariana Arias Avila: lead

Study Sites (1)

Academia O2

São Carlos, São Paulo, 13562-003, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25786047 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Tania F Salvini, PhD

  UFSCar

  STUDY DIRECTOR

• Antonio Roberto Zamunér, MSc

  UFSCar

  PRINCIPAL INVESTIGATOR

• Deborah C Trevisan, MSc

  UFSCar

  PRINCIPAL INVESTIGATOR

• Ester Silva, PhD

  UFSCar

  STUDY CHAIR

• Paula R Camargo, PhD

  UFSCar

  STUDY CHAIR

• Patricia Driusso, PhD

  UFSCar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 24, 2013
• Study Start: July 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 24, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)