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FibromyalgiaNCT03503760

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

A study testing LIMFA Therapy® in people with Fibromyalgia, run by Azienda Ospedaliera Universitaria Integrata Verona.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Fibromyalgia
What is being tested?
LIMFA Therapy®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
Jul 2016to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients: Effect on Symptoms Severity, Sleep and Quality of Life.

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.

Read the 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.

Conditions
Fibromyalgia
Being tested
LIMFA Therapy®
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
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03503760
Study groupRoleWhat they receive
true-shamExperimentalPatients 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.
Receives: Device: LIMFA Therapy®
sham-trueExperimentalPatients 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.
Receives: Device: LIMFA Therapy®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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))

    Measured: 12 weeks

Secondary outcomes (2)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study startJul 2016
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
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
Double blind
Who is masked
Participant, Care provider
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503760
Sponsor's protocol ID
CESC prot. ELF-925
Status last verified
Apr 2018
First submitted
20 Mar 2018
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26445775

  • 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.

    PubMed 20461783

  • 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.

    PubMed 22526760

  • 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.

    PubMed 12942697

  • 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.

    PubMed 8628042

  • 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.

    PubMed 28475205

  • 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.

    PubMed 10897384

  • 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.

    PubMed 19369473

Questions about this trial

What is this clinical trial studying?

A study testing LIMFA Therapy® in people with Fibromyalgia, run by Azienda Ospedaliera Universitaria Integrata Verona.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FIQ (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503760, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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