Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients

Study Overview
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Brief Summary
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This is a randomized double-blind crossover study. The investigators applied ELF with a device named LIMFA Therapy® to 48 fibromyalgic patients, assigned in two groups (true-sham and sham-true). Fibromyalgia severity was assessed with the Fibromyalgia Impact Questionnaire (FIQ), quality of sleep with the Pittsburgh Sleep Quality Index (PSQI) questionnaire and global quality of life with Short Form-12 of Physical and Mental Health Summary (SF-12) questionnaire.

Detailed Description
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In the first part of the protocol the group true-sham received 6 twice a week sessions of true ELF therapy of 1 hour, following the antinflammatory, analgesic and biorhythm settings of the device LIMFA Therapy®. The sham-true group patients received 6 twice a week sessions of sham therapy (no therapy). During the second part of the protocol, the true-sham group received the sham therapy twice a week for 3 weeks and the sham-true group received the actual true therapy twice a week for 3 weeks. For the assessment of pain, sleep quality and global quality of life, a set of questionnaires were administrated at specific stages of the protocol. Questionnaires were administrated every three weeks: before the first therapy, after the first course of therapy, after the washout period, after the second course of therapy, and 3 weeks after the end of treatment.

Official Title
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Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients: Effect on Symptoms Severity, Sleep and Quality of Life.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: LIMFA Therapy®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with an established fibromyalgia diagnosis of at least three months according to American College of Rheumatology 2010 modified criteria and no responsive to their current therapy. patients were not responsive to amitryptiline, selective serotonin reuptake inhibitor (SSRI) or duloxetine and pregabalin (with a pain reduction below 50% compared to pre-therapy or intolerant to these drugs) patients with a pain level measured with Visual Analogue Scale for Pain (VAS) > 50/100. patients that had been taking other drugs or food supplements for the treatment of fibromyalgia for at least 6 months. Exclusion Criteria: patients that completed either physiotherapy or acupuncture or behavioral treatment in the last 6 months patients that were affected by other painful syndromes or potentially painful syndromes other than fibromyalgia. pregnant women pace-maker carriers oncologic patients tuberculotic patients.
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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients have been randomized in two groups using Research randomizer avaliable at www.randomizer.org. The first group of patients true-sham received 6 twice a week sessions of true ELF therapy of one hour with LIMFA Therapy®, following the antinflammatory, analgesic and biorhythm settings of the device. Then, after a wash-out period (three weeks), it received the sham therapy (no therapy) twice a week for three weeks. The second group sham-true received 6 twice a week sessions of sham therapy (no therapy) and then, after the wash-out period (three weeks), it received 6 session of true ELF therapy twice a week for three weeks. A set of questionnaires were administrated: before first session, after first session, after the wash-out period, after second session and after three week follow-up in both groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: true-sham<br>Patients first received the true LIMFA Therapy® treatment for 3 weeks followed by 3 weeks of washout and then six sham sessions for 3 weeks more. | Device: LIMFA Therapy®<br>* It applies a packages of magneto-electric field sequences having variable geometry, with frequencies and intensities that vary in a range of 0-80 Hertz and 0-100 microTesla, respectively.<br>|
| Experimental: sham-true<br>Patients first received the sham treatment for 3 weeks followed by 3 weeks of washout and then six true LIMFA Therapy® sessions for 3 weeks more. | Device: LIMFA Therapy®<br>* It applies a packages of magneto-electric field sequences having variable geometry, with frequencies and intensities that vary in a range of 0-80 Hertz and 0-100 microTesla, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIQ | Fibromyalgia Impact Questionnaire is a comprehensive questionnaire for evaluation of fibromyalgia severity. The scale range is from 0 to100 and higher values are considered worse outcomes. In the severity analysis a FIQ score from 0 to 38 represents a mild condition, from 39 to 58 represents a moderate condition, and from 59 to 100 a severe condition. A reduction of FIQ between 10 and 20% is related to a clinically significative intervention. (Bennett, R. et al.(2009)) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSQI | Pittsburgh Sleep Quality Index questionnaire measures the quality of sleep. The scale range is from 0 to 21. Higher scores are related to worse sleep condition and the best cut-off score is 5: starting from it, people are identified as affected by sleep disorders. A significant reduction of sleep impairment after treatment is one of the secondary outcome. | 12 weeks | 
| SF-12 | Short Form-12 of Physical and Mental Health Summary measures global quality of life. The results consist of two index: Physical Component Summary(PCS) and Mental Component Summary(MCS). The lower outcomes represent a worse physical and mental condition. A significant improvement of quality of life after treatment is one of the secondary outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extremely low magnetic field (ELF), Fibromyalgia impact questionnaire (FIQ), Pittsburgh Sleep Quality Index (PSQI), Short Form-12 of Physical and Mental Health Summary (SF-12), LIMFA Therapy® machine from Eywa Srl system