Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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The purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.

Official Title
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Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Very Low Frequency Magnetic Fields
* Device: Very Low Frequency Magnetic Fields


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010) Subjects aged between 18 and 60 years Exclusion Criteria: Pregnant patients Patients with pacemaker or other metal implants Systemic infectious disorders Neoplastic disorders Epilepsy Severe heart disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very low frequency magnetic fields<br>The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. | Device: Very Low Frequency Magnetic Fields<br>* The device is set to an analgesic program lasting about 30 minutes.<br>* Other names: ELF;|
| Placebo Comparator: Turned off very low frequency magnetic fields<br>The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. | Device: Very Low Frequency Magnetic Fields<br>* The device is turned off.<br>* Other names: ELF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual Analogue Scale (VAS) from baseline to 12 weeks | It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements. | baseline, 4 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks | The questionnaire assesses disability and symptoms. It is divided into ten sub-categories that assess the range of symptoms presented by the patient and the response to therapy and structured in twenty questions that assess disability in activities of daily living (ADL), the difficulties in practice, the feeling of general well-being, sleep, severity of symptoms, including pain, fatigue, depression, anxiety and rigidity. The questionnaire is self-administered disease-specific, and each item is based on a metric scale ranging from 0 (no disability) to 10 (maximum disability). | baseline, 4 weeks, 12 weeks | 
| Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks | The questionnaire assesses the response to therapy and the progression of the disease. Specifically it evaluates fatigue, sleep disorders and pain. The questionnaire is disease-specific, self-administered and is constituted by a pain map, called Self-Assessment Pain Scale (SAPS) characterized by a metric scale from 0 to 3 and by two numerical scales for the assessment of fatigue and sleep quality, each characterized by a metric scale between 0 and 106. | baseline, 4 weeks, 12 weeks | 
| Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks | This questionnaire assesses disability. It is divided into eight domains that assess the dressing, eating, getting up, walking, hygiene, activities of achievement and activities of daily life. The questionnaire is self-administered and each item is based on a metric scale ranging from 0 (no disability) to 3 (maximum disability). | baseline, 4 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromylgia, Magnetic Fields, Pain, Visual Analogue scale