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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: LIMFA Therapy®

• Registration Number: NCT03503760
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Study First Submitted: 2018-03-20
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-11
• Last Update Submitted: 2018-04-11
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sham-true	LIMFA Therapy®	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.
true-sham	LIMFA Therapy®	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.

Primary Outcome Measures

Name	Time	Method
FIQ	12 weeks	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))

Secondary Outcome Measures

Name	Time	Method
PSQI	12 weeks	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.
SF-12	12 weeks	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.