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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Hydrotherapy

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Carlos, SP, Brazil, 13562-003
      • Academia O2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D Kinematics and electromyography	3D kinematics and electromyography will be evaluated with Flock of Birds, Motion Monitor Software and Delsys EMG Device	up to 5 months from the initial interview

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Balance will be assessed by a force platform, in which patients will have to stand up still in some specific positions.	up to 5 months from the initial interview
Function	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.	up to 5 months from the initial interview
Cardiorespiratory Status	Cardiorespiratory status will be assessed by the heart rate variability, the ECG and the ergometric test	up to 5 months from initial interview

Collaborators and Investigators

• Sponsor: Mariana Arias Avila
• Investigators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 19, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Physical Therapy; Fibromyalgia; Kinematics; 3D Kinematics; Heart Rate Frequency; Hydrotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 485/2011; FAPESP (Other Grant/Funding Number: 2010/50120-4)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No