Skip to main content
OpenTrials
Completed

NCT Number: NCT01839305

Effects of Hydrotherapy on Physical Function and Quality of Life of 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Academia O2

São Carlos, São Paulo, 13562-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Mariana Arias Avila

Other

Registry information

Official study title

Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 24, 2013
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.