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

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: LIMFA Therapy®

Study type: Interventional

Funder types: Other

Identifiers

NCT03503760

CESC prot. ELF-925

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups

true-sham

Experimental group

Description:

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.

Treatment:

Device: LIMFA Therapy®

sham-true

Experimental group

Description:

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.

Treatment:

Device: LIMFA Therapy®