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Completed

NCT Number: NCT02231541

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very Low Frequency Magnetic Fields

Device

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

Other names: ELF

Primary outcomes

  1. 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

  1. 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).

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 4, 2014
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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