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

University of Roma La Sapienza1 site in 1 country37 target enrollmentSeptember 2014

ConditionsFibromyalgia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: University of Roma La Sapienza
Enrollment: 37
Locations: 1
Primary Endpoint: Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

March 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

University of Roma La Sapienza

Responsible Party

Principal Investigator

Teresa Paolucci

medical director

University of Roma La Sapienza

Eligibility Criteria

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
•Severe heart disease

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change of Fibromylgia Impact Questionnaire (FIQ) 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)
Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)