Trial record 38 of 157 for:    fibromyalgia | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2016 by Universidade da Coruña
Sponsor:
Information provided by (Responsible Party):
Sabela Rivas Neira, PhD, Universidade da Coruña
ClinicalTrials.gov Identifier:
NCT02695875
First received: February 18, 2016
Last updated: February 24, 2016
Last verified: February 2016
  Purpose

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 Intervention
Fibromyalgia
Procedure: Aquatic therapy
Procedure: Land-based therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Universidade da Coruña:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Pain will be assessed using the visual analog scale (VAS).

  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]
    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:
  • 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). ] [ Designated as safety issue: No ]
    It will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR).

  • 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). ] [ Designated as safety issue: No ]
    It will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI).

  • 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). ] [ Designated as safety issue: No ]
    It will be evaluated with the "Multidimensional Fatigue Inventory" (MFI).

  • 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). ] [ Designated as safety issue: No ]
    It will be measured with the "six minute walk test" (SMWT).

  • 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). ] [ Designated as safety issue: No ]
    It will be assessed with the "Activities-specific Balance Confidence" scale (ABC).

  • 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). ] [ Designated as safety issue: No ]
    It will be assessed using an electronic algometer.

  • 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). ] [ Designated as safety issue: No ]
    It will be assessed using the Berg Balance Scale.


Estimated Enrollment: 34
Study Start Date: October 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02695875

Contacts
Contact: Sabela Rivas Neira, Physiotherapy +34 655422046 sabelarivas@gmail.com
Contact: Jamile Vivas Costa, Physiotherapy +34 661728830 jvivas@udc.es

Sponsors and Collaborators
Universidade da Coruña
Investigators
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
  More Information

Responsible Party: Sabela Rivas Neira, PhD, PhD, Universidade da Coruña
ClinicalTrials.gov Identifier: NCT02695875     History of Changes
Other Study ID Numbers: FIB-2014 
Study First Received: February 18, 2016
Last Updated: February 24, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Universidade da Coruña:
Fibromyalgia
Pain
Postural balance
Physical therapy
Aquatic therapy

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 25, 2016