Effects of Pain Therapeutic Education and Hydrotherapy on Physical Function, Pain and Sleep of Women With Fibromyalgia

November 3, 2020 updated by: Mariana Arias Avila, Universidade Federal de Sao Carlos

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Carlos, SP, Brazil, 13565-905
        • Federal University of São Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinical and medical Fibromyalgia Diagnosis according to ACR Diagnostic criteria 2010 and 2016;
  • Willing to perform hydrotherapy as treatment.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Hydrotherapy

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.
Other: Hydrotherapy
Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.
Experimental: Hydrotherapy and Pain Education

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.
Other: Hydrotherapy
Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.
Other: Pain Education
Together with hydrotherapy, patients will receive pain therapeutic education
Other Names:
  • Pain Neuroscience Education, Pain Therapeutic Education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Number of active myofascial trigger points
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.
Depression clinical symptoms (measured through Hospital Anxiety and Depression Scale)
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.
Anxiety clinical symptoms (measured through Hospital Anxiety and Depression Scale)
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.
Quality of life measured through Revised Fibromyalgia Impact Questionnaire
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.
Quality of life measured through questionnaire Medical Outcomes Sudy 36-item Short-Form Health Survey (sf-36)
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.
Sleep quality measured through two questionnaires: Pittsburgh Quality of Sleep Index and Epworth Sleepiness Scale
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.
For the Pain Therapeutic Education group, index of Pain Neurophysiology learning with an specific questionnaire
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.
Fibromyalgia Knowledge will be measured through Fibromyalgia Knowledge Questionnaire
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.
Appraissal of Self-Care Agency through The Appraisal of Self-Care Agency Scale - Revised (ASAS-R) scores
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.
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.
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.
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.
After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Sao Carlos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mariana A Avila, Ph.D., Ufscar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFSCarFMS
  • 2017/03278-0 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All results shall be disclosed in a form that no individual volunteers shall be identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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