FibromyalgiaNCT02695875
Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia
A study testing Aquatic therapy and Land-based therapy in people with Fibromyalgia, run by Universidade da Coruña at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Aquatic therapy and Land-based therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Asociación Coruñesa de Fibromialgia, Síndrome de Fatiga Crónica y Sensibilidad Química Múltiple (ACOFIFA)
A Coruña, A Coruña, 15006
About this study
Official title: Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome
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).
Read more
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
- Being tested
- Aquatic therapy, Land-based therapy
- Keywords
- Fibromyalgia, Pain, Postural balance, Physical therapy, Aquatic therapy
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic therapyProcedure or surgery
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 therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic therapy | Experimental | 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. Receives: Procedure: Aquatic therapy |
| Land-based therapy | Other | 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". Receives: Procedure: Land-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Pain at 3 months of therapy and one month and a half after treatment.
Pain will be assessed using the visual analog scale (VAS).
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment.
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.
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment.
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.
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Secondary outcomes (7)
Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment.
It will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR).
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment.
It will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI).
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Fatigue at 3 months of therapy and one month and a half after treatment.
It will be evaluated with the "Multidimensional Fatigue Inventory" (MFI).
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Physical Capacity at 3 months of therapy and one month and a half after treatment.
It will be measured with the "six minute walk test" (SMWT).
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Confidence in Balance at 3 months of therapy and one month and a half after treatment.
It will be assessed with the "Activities-specific Balance Confidence" scale (ABC).
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
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.
It will be assessed using an electronic algometer.
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Change from baseline Functional Independence to perform activities of daily living at 3 months of therapy and one month and a half after treatment.
It will be assessed using the Berg Balance Scale.
Measured: It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabela Rivas Neira, PhD, Universidade da Coruña
- Investigators
- Sabela Rivas Neira, Physiotherapy, Principal investigator, Facultade de Fisioterapia da Universidade da CoruñaJamile Vivas Costa, Physiotherapy, Study director, Facultade de Fisioterapia da Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695875
- Sponsor's protocol ID
- FIB-2014
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2016
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rivas Neira S, Pasqual Marques A, Fernandez Cervantes R, Seoane Pillado MT, Vivas Costa J. Efficacy of aquatic vs land-based therapy for pain management in women with fibromyalgia: a randomised controlled trial. Physiotherapy. 2024 Jun;123:91-101. doi: 10.1016/j.physio.2024.02.005. Epub 2024 Feb 17.
PubMed 38447497Rivas 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.
PubMed 28103853
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT02695875
- Acronym / sponsor ID
- FIB-2014
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Postural balance, Physical therapy, Aquatic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic therapy | Experimental | Procedure: Aquatic therapyAquatic 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. |
| Land-based therapy | Other | Procedure: Land-based therapyThe 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". |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic therapyPool 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 or surgery | Aquatic therapy |
| Land-based therapyThe 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. | Procedure or surgery | Land-based therapy |
Primary outcome
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).
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.
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.
7 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 38447497Rivas Neira S, Pasqual Marques A, Fernandez Cervantes R, Seoane Pillado MT, Vivas Costa J. Efficacy of aquatic vs land-based therapy for pain management in women with fibromyalgia: a randomised controlled trial. Physiotherapy. 2024 Jun;123:91-101. doi: 10.1016/j.physio.2024.02.005. Epub 2024 Feb 17.
- Derived from this study: PubMed 28103853Rivas 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.
- Individual participant dataSharing planned: Undecided
Related trials for Fibromyalgia
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabela Rivas Neira, Physiotherapy principal investigator
Facultade de Fisioterapia da Universidade da Coruña
Jamile Vivas Costa, Physiotherapy study director
Facultade de Fisioterapia da Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic therapy and Land-based therapy in people with Fibromyalgia, run by Universidade da Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02695875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.