Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

NCT ID: NCT02231541

Last Updated: 2015-06-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Very Low Frequency Magnetic Fields

Intervention Type DEVICE

The device is set to an analgesic program lasting about 30 minutes.

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.

Group Type PLACEBO_COMPARATOR

Very Low Frequency Magnetic Fields

Intervention Type DEVICE

The device is turned off.

Interventions

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Very Low Frequency Magnetic Fields

The device is set to an analgesic program lasting about 30 minutes.

Intervention Type DEVICE

Very Low Frequency Magnetic Fields

The device is turned off.

Intervention Type DEVICE

Other Intervention Names

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ELF ELF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Teresa Paolucci

medical director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Maria Saraceni

Role: PRINCIPAL_INVESTIGATOR

Umberto I Hospital, Sapienza University of Rome

Locations

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Umberto I Hospital

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 28475205 (View on PubMed)

Other Identifiers

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3295/2014

Identifier Type: -

Identifier Source: org_study_id

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