<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/NCT01725295</url>
  </required_header>
  <id_info>
    <org_study_id>NST</org_study_id>
    <nct_id>NCT01725295</nct_id>
  </id_info>
  <brief_title>Neurostructural Integration Technique for Fibromyalgia</brief_title>
  <acronym>NST</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University College Dublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College Dublin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have&#xD;
      found that our patients seem to benefit from a soft tissue physical therapy called&#xD;
      neurostructural integration therapy (NST). The purpose of this study was to compare NST to&#xD;
      hydrotherapy which is already used to manage fibromyalgia symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty female patients who met the American College of Rheumatology diagnostic criteria for&#xD;
      the classification of FM were enrolled in the study. Patients were randomly allocated to&#xD;
      receive either hydrotherapy or NST. Patient evaluations were performed at baseline, six&#xD;
      weeks, three months, and six months. Primary outcome measures included the SF-36 quality of&#xD;
      life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score.&#xD;
      Duration of morning stiffness and duration of weekly aerobic exercise as reported by the&#xD;
      participants were secondary outcome measures. Statistics analysis was performed by standard&#xD;
      parametric and non parametric methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2003</start_date>
  <completion_date type="Actual">April 2004</completion_date>
  <primary_completion_date type="Actual">April 2004</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single</masking>
  </study_design_info>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>NST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A form of physical therapy to relieve symptoms of fibromyalgia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An alternate form of physical therapy to relieve symptoms of fibromyalgia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NST</intervention_name>
    <description>A form of physical therapy</description>
    <arm_group_label>NST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydrotherapy</intervention_name>
    <arm_group_label>Hydrotherapy</arm_group_label>
    <other_name>A form of physical therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who fulfills ACR diagnostic criteria for fibromyalgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with established ischemic heart disease, uncontrolled hypertension or&#xD;
             diabetes, hypothyroidism, severe depression&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mater Misericordiae Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Dublin</investigator_affiliation>
    <investigator_full_name>Professor Geraldine McCarthy</investigator_full_name>
    <investigator_title>Consultant Rheumatologist</investigator_title>
  </responsible_party>
  <keyword>fibromyalgia treatment</keyword>
  <keyword>physical therapy</keyword>
  <keyword>hydrotherapy</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/NCT01725295
org study id: NST
nct id: NCT01725295
lead sponsor: 
has dmc: No
Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have
      found that our patients seem to benefit from a soft tissue physical therapy called
      neurostructural integration therapy (NST). The purpose of this study was to compare NST to
      hydrotherapy which is already used to manage fibromyalgia symptoms.
Twenty female patients who met the American College of Rheumatology diagnostic criteria for
      the classification of FM were enrolled in the study. Patients were randomly allocated to
      receive either hydrotherapy or NST. Patient evaluations were performed at baseline, six
      weeks, three months, and six months. Primary outcome measures included the SF-36 quality of
      life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score.
      Duration of morning stiffness and duration of weekly aerobic exercise as reported by the
      participants were secondary outcome measures. Statistics analysis was performed by standard
      parametric and non parametric methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
arm group label: NST
arm group type: Experimental
description: A form of physical therapy to relieve symptoms of fibromyalgia
arm group label: Hydrotherapy
arm group type: Active Comparator
description: An alternate form of physical therapy to relieve symptoms of fibromyalgia
intervention type: Other
intervention name: NST
description: A form of physical therapy
arm group label: NST
intervention type: Other
intervention name: Hydrotherapy
arm group label: Hydrotherapy
other name: A form of physical therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University College Dublin
investigator full name: Professor Geraldine McCarthy
investigator title: Consultant Rheumatologist
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes