Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231541
• Other study ID #: 3295/2014
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: June 4, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Very Low Frequency Magnetic Fields
The device is set to an analgesic program lasting about 30 minutes.
• Very Low Frequency Magnetic Fields
The device is turned off.

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 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	Yes
Secondary	Change of Fibromylgia Assessment Status (FAS) from baseline to 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	Yes
Secondary	Change of Health Assessment Questionnaire (HAQ) from baseline to 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	Yes