Pain Education and Therapeutic Exercise for Fibromyalgia

March 23, 2021 updated by: Sandra Jiménez, Universidad de Zaragoza

Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia

Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

The objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.

For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.

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.

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.
32

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

  • Spain
      • Soria, Spain, 42004
        • Sandra Jiménez del Barrio

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed medically with Fibromyalgia
  • Diagnosed according to the American College of Rheumatology criteria
  • Agreement to attend to treatment sessions

Exclusion Criteria:

  • Any kind of contraindications for physical activity
  • Other kind of diseases that could limit the intervention
  • Previous surgery last year
  • Medication modifications in the last 3 months

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.
Experimental: Pain education plus exercise therapy (PE + ET)

Pain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
Other: PE+ET

To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain.

To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Active Comparator: Exercise therapy (ET)
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
Other: ET
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

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
Pain Intensity: VAS
Time Frame: Baseline
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline
Baseline
Pain Intensity: VAS
Time Frame: through study completion, an average 10 weeks
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
through study completion, an average 10 weeks
Fibromyalgia Impact Questionnaire
Time Frame: Baseline
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline
Baseline
Fibromyalgia Impact Questionnaire
Time Frame: through study completion, an average 10 weeks
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention
through study completion, an average 10 weeks

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
Quality of Sleep
Time Frame: Baseline
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Baseline
Pressure pain threshold
Time Frame: through study completion, an average 10 weeks
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment
through study completion, an average 10 weeks
Fatigue
Time Frame: Baseline
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline
Baseline
Fatigue
Time Frame: through study completion, an average 10 weeks
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention
through study completion, an average 10 weeks
Quality of Sleep: Pittsburg Sleeping Questionnaire
Time Frame: through study completion, an average 10 weeks
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention
through study completion, an average 10 weeks
Functional Capacity
Time Frame: Baseline
The investigators measure the functional capacity with Senior Fitness Test at baseline
Baseline
Functional Capacity
Time Frame: through study completion, an average 10 weeks
The investigators measure the functional capacity with Senior Fitness Test at the end of treatment
through study completion, an average 10 weeks
body strength
Time Frame: baseline
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline
baseline
body strength
Time Frame: through study completion, an average 10 weeks
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment
through study completion, an average 10 weeks
Pressure pain threshold
Time Frame: baseline
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline
baseline
Anxiety and Depression
Time Frame: Baseline
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline
Baseline
Anxiety and Depression
Time Frame: through study completion, an average 10 weeks
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention
through study completion, an average 10 weeks
kinesiophobia
Time Frame: baseline
The investigators measure the kinesiophobia with TAMPA questionnaire at baseline
baseline
kinesiophobia
Time Frame: through study completion, an average 10 weeks
The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment
through study completion, an average 10 weeks
Quality of life: HAQ
Time Frame: baseline
The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline
baseline
Quality of life: HAQ
Time Frame: through study completion, an average 10 weeks
The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment
through study completion, an average 10 weeks
Central sensitization
Time Frame: baseline
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
baseline
Central sensitization
Time Frame: through study completion, an average 10 weeks
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment
through study completion, an average 10 weeks

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.
Universidad de Zaragoza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Valladolid

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.
September 3, 2018

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.
January 30, 2019

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.
January 30, 2019

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).
August 16, 2018

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.
August 21, 2018

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.
August 22, 2018

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.
March 26, 2021

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.
March 23, 2021

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.
March 1, 2021

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.
  • University of Valladolid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The patient data were confidential and were assigned a number to each patient to maintain confidentiality

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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