Clinical trial NCT03503760: Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients
Official title: Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients: Effect on Symptoms Severity, Sleep and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: 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
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: FIQ
timeFrame: 12 weeks
Secondary outcomes:
measure: PSQI
timeFrame: 12 weeks
measure: SF-12
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Borchers AT, Gershwin ME. Fibromyalgia: A Critical and Comprehensive Review. Clin Rev Allergy Immunol. 2015 Oct;49(2):100-51. doi: 10.1007/s12016-015-8509-4.
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
citation: Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
citation: Sarzi-Puttini P, Atzeni F, Fiorini T, Panni B, Randisi G, Turiel M, Carrabba M. Validation of an Italian version of the Fibromyalgia Impact Questionnaire (FIQ-I). Clin Exp Rheumatol. 2003 Jul-Aug;21(4):459-64.
citation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
citation: Paolucci T, Piccinini G, Iosa M, Piermattei C, de Angelis S, Grasso MR, Zangrando F, Saraceni VM. Efficacy of extremely low-frequency magnetic field in fibromyalgia pain: A pilot study. J Rehabil Res Dev. 2016;53(6):1023-1034. doi: 10.1682/JRRD.2015.04.0061.
citation: Quittan M, Schuhfried O, Wiesinger GF, Fialka-Moser V. [Clinical effectiveness of magnetic field therapy--a review of the literature]. Acta Med Austriaca. 2000;27(3):61-8. doi: 10.1046/j.1563-2571.2000.270210.x. German.
citation: Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.