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

NCT ID: NCT01839305

Last Updated: 2016-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Hydrotherapy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mariana Arias Avila

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mariana Arias Avila

MSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tania F Salvini, PhD

Role: STUDY_DIRECTOR

UFSCar

Antonio Roberto Zamunér, MSc

Role: PRINCIPAL_INVESTIGATOR

UFSCar

Deborah C Trevisan, MSc

Role: PRINCIPAL_INVESTIGATOR

UFSCar

Ester Silva, PhD

Role: STUDY_CHAIR

UFSCar

Paula R Camargo, PhD

Role: STUDY_CHAIR

UFSCar

Patricia Driusso, PhD

Role: STUDY_CHAIR

UFSCar

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Academia O2

São Carlos, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25786047 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FAPESP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

485/2011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Heat Therapy for Fibromyalgia
NCT03768947 COMPLETED NA