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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • 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

      • 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

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
Intervention / Treatment
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.

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.
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

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

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.

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)

September 3, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

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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