Clinical trial NCT02695875: Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia
Official title: Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Pain
Postural balance
Physical therapy
Aquatic therapy
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Female.
* Age range between 35 and 64 years.
* Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR) in 1990 and 2010.
* Mark ≥ 4 on the Visual Analogue Scale (VAS).
* Mark ≥ 5 on the Visual Analogue Scale for balance included in The Revised Fibromyalgia Impact Questionnaire (FIQR).

Exclusion Criteria:

* History of severe trauma.
* Neurological diseases (stroke, Parkinson's disease, dementia).
* Frequent migraines.
* Inflammatory rheumatic diseases.
* People who have been treated in the past six months by traumatic injuries.
* Being pregnant.
* Visual or hearing deficits uncorrected.
* Infectious diseases.
* Severe cardiovascular disease.
* People who do exercise regularly more than 20 minutes, more than 3 times a week in the past 3 months.

Primary outcomes:
measure: Change from baseline Pain at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Secondary outcomes:
measure: Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Fatigue at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Physical Capacity at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Confidence in Balance at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Pain Threshold for each one of the 18 tender points established at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
measure: Change from baseline Functional Independence to perform activities of daily living at 3 months of therapy and one month and a half after treatment.
timeFrame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Asociación Coruñesa de Fibromialgia, Síndrome de Fatiga Crónica y Sensibilidad Química Múltiple (ACOFIFA)
Study officials:
affiliation: Facultade de Fisioterapia da Universidade da Coruña
name: Sabela Rivas Neira, Physiotherapy
role: PRINCIPAL_INVESTIGATOR
affiliation: Facultade de Fisioterapia da Universidade da Coruña
name: Jamile Vivas Costa, Physiotherapy
role: STUDY_DIRECTOR
References:
citation: Rivas Neira S, Pasqual Marques A, Pegito Perez I, Fernandez Cervantes R, Vivas Costa J. Effectiveness of Aquatic Therapy vs Land-based Therapy for Balance and Pain in Women with Fibromyalgia: a study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2017 Jan 19;18(1):22. doi: 10.1186/s12891-016-1364-5.