NCT02695875

Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia

Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidade da Coruña · Academic / Other
• Sex: Female
• Age: 35 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability to those who suffer it. Currently, other treatment resources are being implemented, such as aquatic therapy. This therapy seems to provide positive results in different dimensions of fibromyalgia. The main objective of the study is to determine the effectiveness of a physical therapy program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction and improvement balance at the end of treatment and a month and a half later (follow-up). The type of study is a randomized controlled opened trial. The sample is composed of 34 women with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2 groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will have two primary outcomes: Pain and balance. The intensity of pain will be assessed using the visual analog scale (VAS) and the pain threshold for each one of the 18 tender points will be assessed using a electronic algometer. Static balance will be evaluated with the Romberg's test and the dynamic balance with the Timed Up \& Go test (TUG) and Berg Balance Scale. Both type of balance will be recorded in slow motion and then, will be analysed with a motion software. Secondary outcomes are: The impact of fibromyalgia on patient's lives, that will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR); the sleep quality, that will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI); the fatigue, that will be evaluated witn the "Multidimensional Fatigue Inventory" (MFI); the physical capacity, that will be measured with the "six minute walk test" (SMWT) and confidence in balance that will be assessed with the "Activities-specific Balance Confidence" scale (ABC). Each intervention will last one hour and will be made 3 times a week for three months . It will consist of 4 sections: Warming, exercises for static and dynamic balance training, stretching and relaxation. Statistical analysis will be made using the Statistical Package for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the significance level set for all analysis.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
PROCEDURE	Aquatic therapy	Pool material is contributed by Maria José Jove Foundation. The exercises that will be made during treatment, are designed and developed to improve "core" muscles and, in this way, improve postural balance.
PROCEDURE	Land-based therapy	The material is contributed by Faculty of Physiotherapy at University of "A Coruña". The exercises that will be made during treatment, are designed and developed to improve "core" muscles and, in this way, improve postural balance.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-08-01
• Completion: 2024-12-01
• First posted: 2016-03-01
• Last updated: 2025-04-02

Locations

1 site across 1 country: Spain