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

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

LIMFA Therapy®

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring 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

Eligibility Criteria

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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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

true-sham

sham-true

Arm 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.

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.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

PSQI

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

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.

Full Information

NCT ID

NCT03503760

First Posted

March 20, 2018

Last Updated

April 11, 2018

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

1. Study Identification

Unique Protocol Identification Number

NCT03503760

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

ParticipantCare Provider

Masking Description

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.

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

true-sham

Arm Type

Experimental

Arm 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.

Arm Title

sham-true

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

LIMFA Therapy®

Intervention Description

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.

Primary Outcome Measure Information:

Title

FIQ

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

PSQI

Description

Time Frame

12 weeks

Title

SF-12

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

26445775

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.

Results Reference

background

PubMed Identifier

20461783

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.

Results Reference

background

PubMed Identifier

22526760

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.

Results Reference

background

PubMed Identifier

12942697

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.

Results Reference

background

PubMed Identifier

8628042

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.

Results Reference

background

PubMed Identifier

28475205

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.

Results Reference

background

PubMed Identifier

10897384

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.

Results Reference

background

PubMed Identifier

19369473

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.

Results Reference

background

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

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