Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

Study Overview
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Brief Summary
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The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.

Detailed Description
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At present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . This has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called Pain Neuroscience Education (PNE), having shown evidence in the treatment of pain, disability, catastrophism and physical performance. But despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. Fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. It is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. Scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process. Objectives: To assess the effectiveness of Pain Neuroscience Education and Strength Training to decrease pain and disability; and increasing quality of life and functionality in patients with Fibromyalgia.

Official Title
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Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
* Procedure: USUAL CARE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with fibromyalgia. Duration of pain greater than one year. Generalized or present pain in more than two body regions. Not having participated in pain neuroscience education program. Not having participated in physical exercise programs in the last three months. Exclusion Criteria: Presence of other diseases not related to the musculoskeletal system. Being under medical treatment not related to pain. being under physiotherapeutic treatment related to pain. Unavailability to carry out a physical exercise program. Pregnant or puerperium women. Inability to perform or complete the necessary tests to measure the study variables.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING<br>Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE) sessions and 12 weeks (3 times/week) of STRENGTH TRAINING (ST) | Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING<br>* The subjects of this group will receive an amount of six sessions that will be applied within 12 weeks. Every 15 days, the subjects will come for a consultation to receive a PNE session and review of the exercise program, which will be carried out 3 times a week for 12 weeks.<br>|
| Active Comparator: USUAL CARE<br>The subjects of this group will receive Usual Care. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients, and recommendation of aerobic and flexibility exercise | Procedure: USUAL CARE<br>* Aerobic exercises will consist of a standard table of low intensity stretching exercises, commonly prescribed to fibromyalgia patients. There will be three series of 30 seconds of each stretch, having a total duration of approximately 40 minutes. Each session will be held twice a week, following the recommendations of the American College of Sport Medicine. Monitoring will be performed every 15 days by a physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Self-report Pain Intensity | Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity | at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week). | 
| Change from Central Sensitization symptoms | Measured by the Central Sensitization Inventory (CSI). The total CSI score is between 0-100 points. Scores equal to or greater than 40 points are considered positive for Central Sensitization. | at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week) | 
| Change from Disability | Measured by the Fibromyalgia Impact Questionnaire (FIQ). The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state. | at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from viscoelastic properties. | Measured by the Myoton®. | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | 
| Change from Autonomic Disfunction symptoms | Measured by the Heart Rate Variability. | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | 
| Change from Nerve Conduction Velocity | Measured by the Sensory Nerve Action Potential (SNAP). | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | 
| Change from grip strength | Measure by the dynamometer. | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | 
| Change from the pressure pain threshold | Measure by the pressure algometer. | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Education, Strength training