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Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in 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: NCT02695875
Recruitment Status : Active, not recruiting
First Posted : March 1, 2016
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sabela Rivas Neira, PhD, Universidade da Coruña

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: Aquatic therapy Procedure: Land-based therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Aquatic therapy
Aquatic therapy is the experimental group. This therapy will take place in a warm pool which is located in Rialta's Sports Complex. Aquatic therapy session will be conducted by the main researcher with the help of an assistant. Because the number of patients (n=17), they will be subdivided into two subgroups of 8 and 9 people respectively in order to ensure the safety and care of patients. The intervention will last for one hour: Warming (15 minutes); exercises to train the static and dynamic balance (25 minutes); stretching (10 minutes); relaxation (10 minutes). Over 12 weeks of treatment, difficulty in performing exercises to train balance will increase progressively.
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.

Land-based therapy
The description is the same as aquatic therapy. The difference is land-based therapy sessions will be made at Faculty of Physiotherapy at University of "A Coruña".
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.





Primary Outcome Measures :
  1. Change from baseline Pain at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    Pain will be assessed using the visual analog scale (VAS).

  2. Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be evaluated with the Romberg's test, whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.

  3. Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be assessed using the Timed Up & Go test (TUG), whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.


Secondary Outcome Measures :
  1. Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR).

  2. Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI).

  3. Change from baseline Fatigue at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be evaluated with the "Multidimensional Fatigue Inventory" (MFI).

  4. Change from baseline Physical Capacity at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be measured with the "six minute walk test" (SMWT).

  5. Change from baseline Confidence in Balance at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be assessed with the "Activities-specific Balance Confidence" scale (ABC).

  6. 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. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be assessed using an electronic algometer.

  7. Change from baseline Functional Independence to perform activities of daily living at 3 months of therapy and one month and a half after treatment. [ Time Frame: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up). ]
    It will be assessed using the Berg Balance Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02695875


Locations
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Spain
Asociación Coruñesa de Fibromialgia, Síndrome de Fatiga Crónica y Sensibilidad Química Múltiple (ACOFIFA)
A Coruña, Spain, 15006
Sponsors and Collaborators
Universidade da Coruña
Investigators
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Principal Investigator: Sabela Rivas Neira, Physiotherapy Facultade de Fisioterapia da Universidade da Coruña
Study Director: Jamile Vivas Costa, Physiotherapy Facultade de Fisioterapia da Universidade da Coruña

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sabela Rivas Neira, PhD, PhD, Universidade da Coruña
ClinicalTrials.gov Identifier: NCT02695875    
Other Study ID Numbers: FIB-2014
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sabela Rivas Neira, PhD, Universidade da Coruña:
Fibromyalgia
Pain
Postural balance
Physical therapy
Aquatic therapy
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases