- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641495
Pain Education and Therapeutic Exercise for Fibromyalgia
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Soria, Spain, 42004
- Sandra Jiménez del Barrio
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity: VAS
Time Frame: Baseline
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The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline
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Baseline
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Pain Intensity: VAS
Time Frame: through study completion, an average 10 weeks
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The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
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through study completion, an average 10 weeks
|
Fibromyalgia Impact Questionnaire
Time Frame: Baseline
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The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline
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Baseline
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Fibromyalgia Impact Questionnaire
Time Frame: through study completion, an average 10 weeks
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The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention
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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
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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
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The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline
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Baseline
|
Fatigue
Time Frame: through study completion, an average 10 weeks
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The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention
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through study completion, an average 10 weeks
|
Quality of Sleep: Pittsburg Sleeping Questionnaire
Time Frame: through study completion, an average 10 weeks
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The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention
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through study completion, an average 10 weeks
|
Functional Capacity
Time Frame: Baseline
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The investigators measure the functional capacity with Senior Fitness Test at baseline
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Baseline
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Functional Capacity
Time Frame: through study completion, an average 10 weeks
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The investigators measure the functional capacity with Senior Fitness Test at the end of treatment
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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
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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
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The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline
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Baseline
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Anxiety and Depression
Time Frame: through study completion, an average 10 weeks
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The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention
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through study completion, an average 10 weeks
|
kinesiophobia
Time Frame: baseline
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The investigators measure the kinesiophobia with TAMPA questionnaire at baseline
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baseline
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kinesiophobia
Time Frame: through study completion, an average 10 weeks
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The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment
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through study completion, an average 10 weeks
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Quality of life: HAQ
Time Frame: baseline
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The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline
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baseline
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Quality of life: HAQ
Time Frame: through study completion, an average 10 weeks
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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
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The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
|
baseline
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Central sensitization
Time Frame: through study completion, an average 10 weeks
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The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment
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through study completion, an average 10 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Valladolid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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