Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

June 4, 2015 updated by: Teresa Paolucci, University of Roma La Sapienza

Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

The purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Umberto I Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
  • Subjects aged between 18 and 60 years

Exclusion Criteria:

  • Pregnant patients
  • Patients with pacemaker or other metal implants
  • Systemic infectious disorders
  • Neoplastic disorders
  • Epilepsy
  • Severe heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Very low frequency magnetic fields
The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues.
Device: Very Low Frequency Magnetic Fields
The device is set to an analgesic program lasting about 30 minutes.
Other Names:
  • ELF
Device: Very Low Frequency Magnetic Fields
The device is turned off.
Other Names:
  • ELF
Placebo Comparator: Turned off very low frequency magnetic fields
The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues.
Device: Very Low Frequency Magnetic Fields
The device is set to an analgesic program lasting about 30 minutes.
Other Names:
  • ELF
Device: Very Low Frequency Magnetic Fields
The device is turned off.
Other Names:
  • ELF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
baseline, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
The questionnaire assesses disability and symptoms. It is divided into ten sub-categories that assess the range of symptoms presented by the patient and the response to therapy and structured in twenty questions that assess disability in activities of daily living (ADL), the difficulties in practice, the feeling of general well-being, sleep, severity of symptoms, including pain, fatigue, depression, anxiety and rigidity. The questionnaire is self-administered disease-specific, and each item is based on a metric scale ranging from 0 (no disability) to 10 (maximum disability).
baseline, 4 weeks, 12 weeks
Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
The questionnaire assesses the response to therapy and the progression of the disease. Specifically it evaluates fatigue, sleep disorders and pain. The questionnaire is disease-specific, self-administered and is constituted by a "pain map", called Self-Assessment Pain Scale (SAPS) characterized by a metric scale from 0 to 3 and by two numerical scales for the assessment of fatigue and sleep quality, each characterized by a metric scale between 0 and 106.
baseline, 4 weeks, 12 weeks
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 12 weeks
This questionnaire assesses disability. It is divided into eight domains that assess the dressing, eating, getting up, walking, hygiene, activities of achievement and activities of daily life. The questionnaire is self-administered and each item is based on a metric scale ranging from 0 (no disability) to 3 (maximum disability).
baseline, 4 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

September 1, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3295/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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