Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients
NCT ID: NCT03503760
Last Updated: 2018-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2016-07-31
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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true-sham
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.
LIMFA Therapy®
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.
sham-true
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.
LIMFA Therapy®
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.
Interventions
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LIMFA Therapy®
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.
Eligibility Criteria
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Inclusion Criteria
* 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 were affected by other painful syndromes or potentially painful syndromes other than fibromyalgia.
* pregnant women
* pace-maker carriers
* oncologic patients
* tuberculotic patients.
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Alvise Martini
MD, Principal Investigator
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CESC prot. ELF-925
Identifier Type: -
Identifier Source: org_study_id
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