Pain Education and Therapeutic Exercise for Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: PE+ET
* Other: ET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain education plus exercise therapy (PE + ET)<br>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<br>* 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.<br>|
| Active Comparator: Exercise therapy (ET)<br>Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations. | Other: ET<br>* To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity: VAS | The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline | Baseline | 
| Pain Intensity: VAS | 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 | The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline | Baseline | 
| Fibromyalgia Impact Questionnaire | 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 |
| --- | --- | --- |
| Fatigue | The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline | Baseline | 
| Fatigue | 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 | The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline | Baseline | 
| Quality of Sleep: Pittsburg Sleeping Questionnaire | 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 | The investigators measure the functional capacity with Senior Fitness Test at baseline | Baseline | 
| Functional Capacity | The investigators measure the functional capacity with Senior Fitness Test at the end of treatment | through study completion, an average 10 weeks | 
| body strength | The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline | baseline | 
| body strength | 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 | 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 | 
| Pressure pain threshold | 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 | 
| Anxiety and Depression | The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline | Baseline | 
| Anxiety and Depression | 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 | The investigators measure the kinesiophobia with TAMPA questionnaire at baseline | baseline | 
| kinesiophobia | The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment | through study completion, an average 10 weeks | 
| Quality of life: HAQ | The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline | baseline | 
| Quality of life: HAQ | 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 | The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline | baseline | 
| Central sensitization | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, therapeutic exercise, physiotherapy