Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

Study Overview
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Brief Summary
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This study evaluates the effects of a pain neuroscience education (PNE) and physical exercise (PE) program in women with fibromyalgia. The intervention group receives PNE and PE program supervised by a physiotherapist and a Family Doctor and the control group standard care, in primary care.

Detailed Description
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Objectives: To evaluate the effectiveness of a PNE and PE in patients with fibromyalgia (FM). Design: Quasi-experimental, controlled, non-randomized study, in Primary Care facilities. Intervention: 6 weekly sessions (2 hours each), and a reminder session one month later. Main measurements: Compliance with FM criteria, assessed using the Widespread Pain Index (WPI) and the Severity of Symptoms (SS) questionnaires, impact of FM in daily life (Fibromyalgia Impact Questionnaire: FIQ) and quality of live. Assessments are made at baseline, one month following the 6th session, and during the 6- and 12-month follow-up.

Official Title
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Effectiveness of a Group Intervention Through Education in Pain Neurophysiology and Exercise in Women With Fibromyalgia: a Quasi-experimental Study in Primary Care

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Pain Neuroscience Education and Physical Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with FM (2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia) Women ≥ 18 years Agree to participate in the study and sign informed consent. Exclusion Criteria: Oncological pain Motor control alteration that prevents the execution of the planned PE program Patients with associated pathologies that make it impossible to perform physical exercise program Any disabling mental illness or intellectual deficit that prevents understanding the contents of PNE program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental, controlled, non-randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later | Other: Pain Neuroscience Education and Physical Exercise<br>* Patients assigned to the experimental group perform a PNE program consisting of seven sessions, with therapeutic PE. PNE is a health education intervention aims to provide up-to-date information on neuroscience advances in the field of chronic pain.<br>|
| No Intervention: Control<br>Standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fulfillment of diagnostic criteria for fibromyalgia | 2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia: dichotomous variable (complies or does not comply). A patient satisfies diagnostic criteria for fibromyalgia if the following 3 conditions are met: Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9. Symptoms have been present at a similar level for at least 3 months. The patient does not have a disorder that would otherwise explain the pain. WPI: number of areas in which the patient has had pain over the last week (score between 0 and 19), with 0 = fully active and 5 = dead). SS: sum of the severity of 3 symptoms (fatigue, waking unrefreshed, cognitive symptoms) plus the extent (severity) of somatic symptoms in general (final score between 0 and 12: higher scores mean a worse outcome) | Change from baseline to 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of fibromyalgia on daily life | Evaluation of physical functionality, global impact and severity of symptoms: Fibromyalgia Impact Questionnaire (FIQ), which ranges from 0 to 100, with higher scores indicating worse outcome | Change from baseline to 12 months follow-up | 
| Catastrophism | Pain-related catastrophizing behaviours and cognitions of individuals: Pain Catastrophizing Scale (PCS), which ranges from 0 to 52, with higher scores indicating worse outcome | Change from baseline to 12 months follow-up | 
| Anxiety | Anxiety sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome | Change in score from baseline to 12 months follow-up | 
| Depression | Depression sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome | Change in score of both subscales from baseline to 12 months follow-up | 
| Pain intensity | Pain intensity sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-40, with higher scores indicating worse outcome | Change from baseline to 12 months follow-up | 
| Impact of pain in person's daily performance | Pain impact sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-70, with higher scores indicating worse outcome | Change from baseline to 12 months follow-up | 
| Functional capacity | Difficulty in performing activities of daily living: Health Assessment Questionnaire (HAQ), which ranges from 0 to 60, with higher scores indicating worse outcome | Change from baseline to 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Nervous System Sensitization, Chronic pain, Fibromyalgia, Neuroscience, Patient education