Explain Pain in Fibromyalgia Patients

Study Overview
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Brief Summary
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Education of pain physiology is described as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. There is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance in chronic musculoskeletal pain disorders. Although pain physiology education has been studied in patients with chronic low back pain, chronic whiplash, and chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM) are limited to a 2013 study with limited results. The investigators propose a study with a higher dose of education of pain physiology (i.e. a higher number of educational sessions and total education time) to study if this generates a larger treatment effect in patients with fibromyalgia.

Official Title
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Explain Pain in Fibromyalgia Patients

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American College of Rheumatology classification criteria for FM, both 1990 and 2010 Reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries On stable doses of medications for FM ≥ 4 weeks Exclusion Criteria: Suffer from an inflammatory rheumatic conditions Have a planned elective surgery during the study period Have ongoing unresolved disability claims Experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis Do not speak Spanish fluently

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Educational program Control Group<br>6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: talk about medical issues (drugs, nutrition, importance of sleep...) | Other: Educational program<br>* Patients in experimental groups will receive different educational sessions (contents and duration)<br>|
| Experimental: Educational program High Dose Group<br>6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises | Other: Educational program<br>* Patients in experimental groups will receive different educational sessions (contents and duration)<br>|
| Experimental: Educational program Diluted Low Dose Group<br>6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises | Other: Educational program<br>* Patients in experimental groups will receive different educational sessions (contents and duration)<br>|
| Experimental: Educational program Concentrated Low Dose Group<br>6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: educational sessions about the neurophysiology of pain | Other: Educational program<br>* Patients in experimental groups will receive different educational sessions (contents and duration)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale | On this continuous, horizontal scale used, where 0 is ''no pain and 100 is ''worst possible pain (0-100 mm line), subjects will be asked to mark the line with a cross somewhere between both extremes that best reflect their sensation | Baseline - 6 weeks - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fibromyalgia Impact Questionnaire | A validated self-reported questionnaire developed for FM (scores range from 0 to 100, average FM patients score about 50 and severely affected patients score >70) wich measures multidimensional function/health-related quality of life. | Baseline - 6 weeks - 3 months | 
| Change in Pressure Pain Threshold | The Pressure Pain Threshold (PPT) is defined as the lowest pressure that, using standardized testing conditions, needs to be applied in order to cause the slightest sensation of pain. It is a reliable and widely used measure. PPTs will be the average intensity of three consecutive measurements, applied every 30 seconds, measured using an analogue Wagner algometer (Wagner Instruments, Greenwich, CT) fitted with a 1 cm2 pressure, with an approximate rate of pressure increase of 1 Kg/s. | Baseline - 6 weeks - 3 months | 
| Change in Medical Outcomes Study Short Form 36 (SF-36) | The Physical Component Summary score of the Medical Outcomes Study Short Form 36 [SF-36] will be used. More than 10% improvement in SF-36 physical function has been identified as a responder-to-treatment definition for FM clinical trials | Baseline - 6 weeks - 3 months | 
| Change in Patient Global Impression of Change Scale | The patient global impression of change scale (PGIC) is recommended for evaluating participant ratings of overall improvement in pain treatment trials. The PGIC uses a 7-point Likert scale that varies from 1 very much improved to 7 very much worse to quantify patient global response to treatment and have been previously used in FM treatment trials. | Baseline - 6 weeks - 3 months | 
| Change in Depression subscale of the Hospital Anxiety and Depression Scale | The Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) includes 7 items to assess depressive symptoms, with each item answered on a four-point (0 to 3) scale so that possible scores range from 0 to 21 with higher scores indicating more severe symptoms. An analysis of data from three pregabalin FM trials supports diagnostic validity of the HADS by showing that, using a standard cutoff score of ≥11 on the HADS-D to identify patients with major depressive disorder | Baseline - 6 weeks - 3 months | 
| Change in Fatigue Severity Scale | The Fatigue Severity Scale (FSS)20 is a 9-item unidimensional measure of fatigue that has been demonstrated to be valid and reliabile in FM patients. The FSS measures fatigue by quantifying the impact of fatigue on specific types of functioning. Each item is scored on a 7-point rating scale, and the FSS score is derived by averaging all items to yield a score from 1 to 7 with higher scores indicating more severe fatigue symptoms. | Baseline - 6 weeks - 3 months | 
| Change in Jenkins Sleep Scale | The Jenkins Sleep Scale (JSS) is a 4-item self-report questionnaire designed to measure how often a subject has experienced sleep problems in the past month and has been studied in FM patients and found to be valid, reliable, and able to detect change after treatment. JSS items evaluate trouble falling asleep, staying asleep, waking up several times, and awakening unrefreshed with each item scored on a 5-point Likert scale from 0 = not at all to 5 = 22-31 days. Scores vary from 0 to 20 with higher scores indicating more frequent sleep problems. | Baseline - 6 weeks - 3 months | 
| Change in Manual Tender Point Survey | The Manual Tender Point Survey (MTPS) is a standardized approach to performing the tender point exam in which FM patients rate pain severity upon digital palpation of each tender point on a verbal 11 point number rating scale. Pain severity ratings from the 18 tender points are averaged to yield a Fibromyalgia Intensity Score (FIS) that varies from 0 to 10 with higher scores indicating more severe tenderness. Change in the severity of pain at tender point sites has been shown to be a better measure of tenderness than change in the number of tender points. | Baseline - 6 weeks - 3 months | 
| Change in Neurophysiology of Pain Test | The Neurophysiology of Pain Test-patient version consists of 19 true-false choice items (scores ranging from 0 to 19, with high scores representing a better knowledge regarding pain neurophysiology). This test evaluates whether patients can understand currently accurate information about the neurophysiology of pain. | Baseline - 6 weeks - 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Patient education, Central sensitization