<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/NCT04421521</url>
  </required_header>
  <id_info>
    <org_study_id>2717</org_study_id>
    <nct_id>NCT04421521</nct_id>
  </id_info>
  <brief_title>Acunpuncture for Fibromyalgia Syndrome</brief_title>
  <official_title>Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      patients suffering from fibromyalgia syndrome according to the criteria of the American&#xD;
      College of Rheumatology 2010 will be enrolled. All fibromyalgic patients will be subjected to&#xD;
      a further ambulatory visit and if an energy deficiency in the Liver and Spleen Meridians will&#xD;
      be identified, according to the Traditional Chinese Medicine rules, acupuncture will be&#xD;
      planned. If not, a standard therapy with analgesic drugs will be started. Acupuncture&#xD;
      treatment will consist of six weekly sessions. Tricyclic antidepressants, anti-epileptic&#xD;
      drugs, selective serotonin reuptake inhibitors and opioids will be used as standard strategy.&#xD;
      Pain Scores and Fatigue Impact Scale will be assessed before any treatment and after a 28&#xD;
      days follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Score</measure>
    <time_frame>28 days after the completion of the treatment</time_frame>
    <description>Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Acupuncture</condition>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Acupuncture Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Therapy Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture with disposable needles will be implemented</description>
    <arm_group_label>Acupuncture Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        clinical diagnosis of Fibromyalgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04421521
org study id: 2717
nct id: NCT04421521
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
patients suffering from fibromyalgia syndrome according to the criteria of the American
      College of Rheumatology 2010 will be enrolled. All fibromyalgic patients will be subjected to
      a further ambulatory visit and if an energy deficiency in the Liver and Spleen Meridians will
      be identified, according to the Traditional Chinese Medicine rules, acupuncture will be
      planned. If not, a standard therapy with analgesic drugs will be started. Acupuncture
      treatment will consist of six weekly sessions. Tricyclic antidepressants, anti-epileptic
      drugs, selective serotonin reuptake inhibitors and opioids will be used as standard strategy.
      Pain Scores and Fatigue Impact Scale will be assessed before any treatment and after a 28
      days follow-up.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Score
time frame: 28 days after the completion of the treatment
description: Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )
arm group label: Acupuncture Group
arm group type: Experimental
arm group label: Standard Therapy Group
arm group type: No Intervention
intervention type: Procedure
intervention name: Acupuncture
description: Acupuncture with disposable needles will be implemented
arm group label: Acupuncture Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes