Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

NCT02231541 | Completed DMC

• 1 other identifier: 3295/2014
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromylgia; Magnetic Fields; Pain; Visual Analogue scale

Outcome Measures

Primary Outcomes (1)

• Change of Visual Analogue Scale (VAS) from baseline to 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 Outcomes (3)

• Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

• Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

• Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

Study Arms (2)

Very low frequency magnetic fields

EXPERIMENTAL

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

Turned off very low frequency magnetic fields

PLACEBO COMPARATOR

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

Interventions

Very Low Frequency Magnetic Fields DEVICE

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

Also known as: ELF

Very low frequency magnetic fields

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincenzo Maria Saraceni

  Umberto I Hospital, Sapienza University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical director

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2014-09

Locations

IT (1)