<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02231541</url>
  </required_header>
  <id_info>
    <org_study_id>3295/2014</org_study_id>
    <nct_id>NCT02231541</nct_id>
  </id_info>
  <brief_title>Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia</brief_title>
  <official_title>Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the effectiveness of treatment with very low&#xD;
      frequency electromagnetic fields on the reduction of pain in patients with fibromylgia,&#xD;
      disease presenting with widespread musculoskeletal pain usually associated with other&#xD;
      symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Visual Analogue Scale (VAS) from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>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 &quot;pain map&quot;, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks</measure>
    <time_frame>baseline, 4 weeks, 12 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Very low frequency magnetic fields</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Turned off very low frequency magnetic fields</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Very Low Frequency Magnetic Fields</intervention_name>
    <description>The device is set to an analgesic program lasting about 30 minutes.</description>
    <arm_group_label>Very low frequency magnetic fields</arm_group_label>
    <other_name>ELF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Very Low Frequency Magnetic Fields</intervention_name>
    <description>The device is turned off.</description>
    <arm_group_label>Turned off very low frequency magnetic fields</arm_group_label>
    <other_name>ELF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgia diagnosed according to the criteria proposed by the American College of&#xD;
             Rheumatology (ACR 2010)&#xD;
&#xD;
          -  Subjects aged between 18 and 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients with pacemaker or other metal implants&#xD;
&#xD;
          -  Systemic infectious disorders&#xD;
&#xD;
          -  Neoplastic disorders&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Severe heart disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincenzo Maria Saraceni</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umberto I Hospital, Sapienza University of Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Umberto I Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>June 4, 2015</last_update_submitted>
  <last_update_submitted_qc>June 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Teresa Paolucci</investigator_full_name>
    <investigator_title>medical director</investigator_title>
  </responsible_party>
  <keyword>Fibromylgia</keyword>
  <keyword>Magnetic Fields</keyword>
  <keyword>Pain</keyword>
  <keyword>Visual Analogue scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02231541
org study id: 3295/2014
nct id: NCT02231541
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: 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.
measure: Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: 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).
measure: Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: 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.
measure: Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
time frame: baseline, 4 weeks, 12 weeks
description: 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).
arm group label: Very low frequency magnetic fields
arm group type: Experimental
description: 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.
arm group label: Turned off very low frequency magnetic fields
arm group type: Placebo Comparator
description: 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.
intervention type: Device
intervention name: Very Low Frequency Magnetic Fields
description: The device is set to an analgesic program lasting about 30 minutes.
arm group label: Very low frequency magnetic fields
other name: ELF
intervention type: Device
intervention name: Very Low Frequency Magnetic Fields
description: The device is turned off.
arm group label: Turned off very low frequency magnetic fields
other name: ELF
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Vincenzo Maria Saraceni
role: Principal Investigator
affiliation: Umberto I Hospital, Sapienza University of Rome
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Teresa Paolucci
investigator title: medical director
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes