Completed

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

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What is being tested

Hydrotherapy

Other
Who is being recruted

Muscular Diseases+3

+ Musculoskeletal Diseases

+ Nervous System Diseases

From 30 to 60 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2011
See protocol details

Summary

Principal SponsorMariana Arias Avila
Last updated: June 24, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01839305
Principal SponsorMariana Arias Avila
Last updated: June 24, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 30 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesRheumatic DiseasesFibromyalgia

Criteria

2 inclusion criteria required to participate
to be aged from 30 to 60 years old
to have a clinical fibromyalgia diagnosis according to the 1990 ACR criteria
7 exclusion criteria prevent from participating
Body Mass index > 28kg/m^2
Cognitive deficits that prevented patients to understand the evaluation procedures
Infections
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)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Academia O2

São Carlos, BrazilOpen Academia O2 in Google Maps
CompletedOne Study Center