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

NCT03503760 | Completed

• 1 other identifier: CESC prot. ELF-925
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PSQI

  12 weeks

• SF-12

  12 weeks

Study Arms (2)

true-sham

EXPERIMENTAL

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®

sham-true

EXPERIMENTAL

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®

Interventions

LIMFA Therapy® DEVICE

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; true-sham

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Related Publications (8)

• 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.

  PMID: 26445775 BACKGROUND

• 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.

  PMID: 20461783 BACKGROUND

• 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.

  PMID: 22526760 BACKGROUND

• 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.

  PMID: 12942697 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 28475205 BACKGROUND

• 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.

  PMID: 10897384 BACKGROUND

• 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.

  PMID: 19369473 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and care provider were unaware of the treatment as the machine does not make any sound or heat during the session. Only the nurse that physically connect the cable to the generator knows if the patient recieve or not the therapy but she was not involved in clinical evaluation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 20, 2018
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 20, 2018

Record last verified: 2018-04