Effects of Hydrotherapy on Physical Function and Quality of Life of Women With Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01839305|
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Hydrotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||March 2014|
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
Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks
- 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.
- 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
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839305
|São Carlos, SP, Brazil, 13562-003|
|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|