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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839305
• Other study ID #: 485/2011
• Secondary ID: FAPESP
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: June 23, 2016
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: June 2016
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Brazil	Academia O2	São Carlos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Mariana Arias Avila

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No