FibromyalgiaNCT03073642
Effects of Pain Therapeutic Education and Hydrotherapy on Physical Function, Pain and Sleep of Women With Fibromyalgia
A study testing Pain Education and Hydrotherapy in people with Fibromyalgia, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Fibromyalgia (FM) is a prevalent and disabling disease, that affects mostly women and its main characteristic is chronic pain. Several studies have shown that hydrotherapy is effective in the improvement of symptoms and quality of life of this population; other studies have shown that Pain Therapeutic Education (PTE)… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pain Education and Hydrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2019to 3 Nov 2020
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and medical Fibromyalgia Diagnosis according to ACR Diagnostic criteria 2010 and 2016;
- Willing to perform hydrotherapy as treatment.
Who cannot join
- Cognitive deficits that prevent volunteers from understanding evaluation and treatment procedures;
- Uncontrolled systemic illnesses (diabetes, hypertension);
- Neurological and musculoskeletal conditions that may interfere in the evaluation and treatment procedures (palsies, sensitivity alterations, advanced osteoarthritis);
- Infecto-contagious illnesses (especially in the urinary tract);
- Alcohol or drug abuse;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pain Therapeutic Education and Hydrotherapy on Pain, Depression, Anxiety, Quality of Life and Quality of Sleep of Women With Fibromyalgia
Fibromyalgia (FM) is a prevalent and disabling disease, that affects mostly women and its main characteristic is chronic pain. Several studies have shown that hydrotherapy is effective in the improvement of symptoms and quality of life of this population; other studies have shown that Pain Therapeutic Education (PTE) is also effective in this sense. PTE is one cheap, easy to apply intervention, with very positive results in chronic pain situations. However, there is a lack of studies that have shown the effects of this intervention on FM. Hence, this study will aim to verify the effectiveness of the hydrotherapy and PTE on women with FM. Sixty women will be randomly allocated in two groups: hydrotherapy and hydrotherapy + PTE. Before treatment start, the investigators will evaluate pain (visual analogue scale, presence of myofascial trigger points and pressure pain threshold over the scalene, upper trapezius, infraspinatus, piriformis, iliopsoas and soleus, bilaterally), quality of life (Fibromyalgia Impact Questionnaire and medical outcomes study 36-item short-form health survey), depression (Beck Depression Inventory), anxiety (Beck Anxiety Inventory) and sleep quality (Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale). Hydrotherapy treatment will last 12 weeks. Women will be evaluated other 3 times: after 6 and 12 weeks (treatment middle and end) and 12 weeks after treatment completion (follow-up). Women in the hydrotherapy group will receive a folder with explanations on FM. Women in the hydrotherapy + PTE will participate of 4 meetings over 12 treatment weeks, in which themes like pain physiology, pain chronification and exacerbation and pain self-management, as well as information on FM will be approached. Statistical analysis will include qualitative and quantitative variable description. Correlation among variables will also be analyzed. Level of significance will be set at 5%.
Read the detailed description
The investigators will select at least 80 women with fibromyalgia (FM) for this study, in which pain (through pressure pain threshold and number of active myofascial trigger points), quality of life, FM impact on quality of life and function, depression, anxiety and quality of sleep will be evaluated.
After evaluating the volunteer, the participant will be randomly allocated to one of two groups: hydrotherapy treatment (HT), and hydrotherapy treatment together with pain therapeutic education (HT+PTE).
All volunteers will perform 12 weeks of hydrotherapy treatment, in which the investigators will perform global exercises for upper and lower limbs and trunk.
Volunteers in the HT+PTE group will receive, throughout the 12 weeks of HT, 4 sessions of PTE, in which the investigators will teach pain neurophysiology, pain chronification and pain management.
Evaluation sessions will take place before treatment, after 6 and 12 weeks of HT and after 12 weeks of treatment ending.
In all evaluations sessions, the investigators will collect data on those aspects previously described.
- Conditions
- Fibromyalgia
- Being tested
- Pain Education, Hydrotherapy
- Keywords
- Hydrotherapy, Pain education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain EducationOther
Also called Pain Neuroscience Education, Pain Therapeutic Education
Together with hydrotherapy, patients will receive pain therapeutic education
HydrotherapyOther
Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hydrotherapy | Active comparator | Patients allocated to this group will perform 12 weeks of hydrotherapy treatment, with global exercises. Hydrotherapy sessions will last 45 minutes and will be performed twice a week.
Exercises will involve aerobic exercises (in the pool) with exercises for upper and lower limbs, and trunk. Receives: Other: Hydrotherapy |
| Hydrotherapy and Pain Education | Experimental | Patients allocated to this group will perform 12 weeks of hydrotherapy treatment, with global exercises. Hydrotherapy sessions will last 45 minutes and will be performed twice a week.
Exercises will involve aerobic exercises (in the pool) with exercises for upper and lower limbs, and trunk.
During the 12 weeks of hydrotherapy treatment, volunteers will also receive 4 sessions of Pain Therapeutic Education, which is also known as Pain Neuroscience Education, which involves patient education on pain neurophysiology, pain chronification and amplification mechanisms, and chronic pain management. These sessions will be performed in specific dates scheduled according to the volunteers' availability, and with intervals that can last from one to two weeks. Receives: Other: Pain Education; Other: Hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain throughout time
Visual Analogue Scale (VAS - 100mm) for pain
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Secondary outcomes (11)
Changes in number of active myofascial trigger points throughout time
Number of active myofascial trigger points
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in depression throughout time
Depression clinical symptoms (measured through Hospital Anxiety and Depression Scale)
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in anxiety throughout time
Anxiety clinical symptoms (measured through Hospital Anxiety and Depression Scale)
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Impact of Fibromyalgia in Quality of life throughout time
Quality of life measured through Revised Fibromyalgia Impact Questionnaire
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Quality of life throughout time
Quality of life measured through questionnaire Medical Outcomes Sudy 36-item Short-Form Health Survey (sf-36)
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Sleep throughout time
Sleep quality measured through two questionnaires: Pittsburgh Quality of Sleep Index and Epworth Sleepiness Scale
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Pain neurophysiology learning throughout time
For the Pain Therapeutic Education group, index of Pain Neurophysiology learning with an specific questionnaire
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in knowledge of Fibromyalgia throughout time
Fibromyalgia Knowledge will be measured through Fibromyalgia Knowledge Questionnaire
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Appraisal of Self-Care Agency throughout time
Appraissal of Self-Care Agency through The Appraisal of Self-Care Agency Scale - Revised (ASAS-R) scores
Measured: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Pacient satisfaction with the intervention
Structured questionnaire through which patient will answer about satisfaction with treatment, with a 5-point Likert Scale, with the possible asnswers: "Totally Agree", "Agree", "Neutral", "Disagree" and "Totally Disagree", relative to the following affirmations: 1) I am satisfied with the treatment I received; 2) I believe this treatment was helpful for my condition; 3) I believe my health status has improved after treatment; 4) I will include in my daily life activities things I have learned during my treatment; 5) I will recommend this treatment to someone who has the same health condition as me.
Measured: After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Patient's perception of change
Self-perception of change with the Global Rating of Change Scale; with this scale from -7 to 7, the participant will rate her perception of change after intervention. The negative values will be considered as a worsening in the health status, and the positive values, as a improvement in the health condition of the participant. Zero will be considered as no change in the health status.
Measured: After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Apr 2019
- Primary completion31 Oct 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- Double blind randomized controlled trial with 1:1 allocation
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Arias Avila, Universidade Federal de Sao Carlos
- Investigators
- Mariana A Avila, Ph.D., Principal investigator, UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073642
- Sponsor's protocol ID
- UFSCarFMS
- Other IDs
- 2017/03278-0, 2017
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results shall be disclosed in a form that no individual volunteers shall be identified.
Publications
Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013 Aug;17(8):356. doi: 10.1007/s11916-013-0356-5.
PubMed 23801009Ortega E, Bote ME, Giraldo E, Garcia JJ. Aquatic exercise improves the monocyte pro- and anti-inflammatory cytokine production balance in fibromyalgia patients. Scand J Med Sci Sports. 2012 Feb;22(1):104-12. doi: 10.1111/j.1600-0838.2010.01132.x. Epub 2010 Jun 1.
PubMed 20536907Sousa AP, Almeida LA, Lourenco BP, Alvares LD, Avila MA. Pain neuroscience education improves quality of life when added to aquatic exercise therapy for women with fibromyalgia: randomized controlled clinical trial. Disabil Rehabil. 2024 Apr;46(8):1559-1569. doi: 10.1080/09638288.2023.2201510. Epub 2023 Apr 18.
PubMed 37070715
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Therapeutic Education and Hydrotherapy on Pain, Depression, Anxiety, Quality of Life and Quality of Sleep of Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03073642
- Acronym / sponsor ID
- UFSCarFMS
- Conditions
- Fibromyalgia
- Keywords
- Hydrotherapy, Pain education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 8 Mar 2017 (actual)
- 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 (FM) is a prevalent and disabling disease, that affects mostly women and its main characteristic is chronic pain. Several studies have shown that hydrotherapy is effective in the improvement of symptoms and quality of life of this population; other studies have shown that Pain Therapeutic Education (PTE) is also effective in this sense. PTE is one cheap, easy to apply intervention, with very positive results in chronic pain situations. However, there is a lack of studies that have shown the effects of this intervention on FM. Hence, this study will aim to verify the effectiveness of the hydrotherapy and PTE on women with FM. Sixty women will be randomly allocated in two groups: hydrotherapy and hydrotherapy + PTE. Before treatment start, the investigators will evaluate pain (visual analogue scale, presence of myofascial trigger points and pressure pain threshold over the scalene, upper trapezius, infraspinatus, piriformis, iliopsoas and soleus, bilaterally), quality of life (Fibromyalgia Impact Questionnaire and medical outcomes study 36-item short-form health survey), depression (Beck Depression Inventory), anxiety (Beck Anxiety Inventory) and sleep quality (Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale). Hydrotherapy treatment will last 12 weeks. Women will be evaluated other 3 times: after 6 and 12 weeks (treatment middle and end) and 12 weeks after treatment completion (follow-up). Women in the hydrotherapy group will receive a folder with explanations on FM. Women in the hydrotherapy + PTE will participate of 4 meetings over 12 treatment weeks, in which themes like pain physiology, pain chronification and exacerbation and pain self-management, as well as information on FM will be approached. Statistical analysis will include qualitative and quantitative variable description. Correlation among variables will also be analyzed. Level of significance will be set at 5%.
Detailed description
The investigators will select at least 80 women with fibromyalgia (FM) for this study, in which pain (through pressure pain threshold and number of active myofascial trigger points), quality of life, FM impact on quality of life and function, depression, anxiety and quality of sleep will be evaluated.
After evaluating the volunteer, the participant will be randomly allocated to one of two groups: hydrotherapy treatment (HT), and hydrotherapy treatment together with pain therapeutic education (HT+PTE).
All volunteers will perform 12 weeks of hydrotherapy treatment, in which the investigators will perform global exercises for upper and lower limbs and trunk.
Volunteers in the HT+PTE group will receive, throughout the 12 weeks of HT, 4 sessions of PTE, in which the investigators will teach pain neurophysiology, pain chronification and pain management.
Evaluation sessions will take place before treatment, after 6 and 12 weeks of HT and after 12 weeks of treatment ending.
In all evaluations sessions, the investigators will collect data on those aspects previously described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trial with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy | Active comparator | Other: HydrotherapyPatients allocated to this group will perform 12 weeks of hydrotherapy treatment, with global exercises. Hydrotherapy sessions will last 45 minutes and will be performed twice a week. Exercises will involve aerobic exercises (in the pool) with exercises for upper and lower limbs, and trunk. |
| Hydrotherapy and Pain Education | Experimental | Other: Pain Education, Other: HydrotherapyPatients allocated to this group will perform 12 weeks of hydrotherapy treatment, with global exercises. Hydrotherapy sessions will last 45 minutes and will be performed twice a week. Exercises will involve aerobic exercises (in the pool) with exercises for upper and lower limbs, and trunk. During the 12 weeks of hydrotherapy treatment, volunteers will also receive 4 sessions of Pain Therapeutic Education, which is also known as Pain Neuroscience Education, which involves patient education on pain neurophysiology, pain chronification and amplification mechanisms, and chronic pain management. These sessions will be performed in specific dates scheduled according to the volunteers' availability, and with intervals that can last from one to two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical and medical Fibromyalgia Diagnosis according to ACR Diagnostic criteria 2010 and 2016;
- Willing to perform hydrotherapy as treatment.
Key exclusion criteria (6 listed)
- Cognitive deficits that prevent volunteers from understanding evaluation and treatment procedures;
- Uncontrolled systemic illnesses (diabetes, hypertension);
- Neurological and musculoskeletal conditions that may interfere in the evaluation and treatment procedures (palsies, sensitivity alterations, advanced osteoarthritis);
- Infecto-contagious illnesses (especially in the urinary tract);
- Alcohol or drug abuse;
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 |
|---|---|---|
| Pain EducationAlso: Pain Neuroscience Education, Pain Therapeutic EducationTogether with hydrotherapy, patients will receive pain therapeutic education | Other | Hydrotherapy and Pain Education |
| HydrotherapyHydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks. | Other | Hydrotherapy, Hydrotherapy and Pain Education |
Primary outcome
Changes in Pain throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Visual Analogue Scale (VAS - 100mm) for pain
11 secondary outcomes
Changes in number of active myofascial trigger points throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in depression throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in anxiety throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Impact of Fibromyalgia in Quality of life throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Quality of life throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Sleep throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Pain neurophysiology learning throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in knowledge of Fibromyalgia throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Appraisal of Self-Care Agency throughout time
Time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Pacient satisfaction with the intervention
Time frame: After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Patient's perception of change
Time frame: After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
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 4 Nov 2020.
- Background: PubMed 23801009Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013 Aug;17(8):356. doi: 10.1007/s11916-013-0356-5.
- Background: PubMed 20536907Ortega E, Bote ME, Giraldo E, Garcia JJ. Aquatic exercise improves the monocyte pro- and anti-inflammatory cytokine production balance in fibromyalgia patients. Scand J Med Sci Sports. 2012 Feb;22(1):104-12. doi: 10.1111/j.1600-0838.2010.01132.x. Epub 2010 Jun 1.
- Derived from this study: PubMed 37070715Sousa AP, Almeida LA, Lourenco BP, Alvares LD, Avila MA. Pain neuroscience education improves quality of life when added to aquatic exercise therapy for women with fibromyalgia: randomized controlled clinical trial. Disabil Rehabil. 2024 Apr;46(8):1559-1569. doi: 10.1080/09638288.2023.2201510. Epub 2023 Apr 18.
- Individual participant dataSharing planned: No. All results shall be disclosed in a form that no individual volunteers shall be identified.
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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.
Mariana A Avila, Ph.D. principal investigator
UFSCar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Education and Hydrotherapy in people with Fibromyalgia, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 2 inclusion and 6 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 4 Nov 2020. 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 Brazil. 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?
Changes in Pain throughout time (time frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.). 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 NCT03073642, which also lists 3 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 4 Nov 2020.