<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/NCT01734577</url>
  </required_header>
  <id_info>
    <org_study_id>UNLVPT-4059</org_study_id>
    <nct_id>NCT01734577</nct_id>
  </id_info>
  <brief_title>Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals</brief_title>
  <official_title>The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of&#xD;
      musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine&#xD;
      for a neurophysiological effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consenting adults will be taught how to contract their abdominal muscles, and to contract&#xD;
      transversus abdominis in particular. They will then have real time ultrasound measurements of&#xD;
      the resting and contracted thickness of their left transversus abdominis muscle. After this,&#xD;
      they will receive actual or sham needling to their left multifidus muscle by another&#xD;
      researchers blinded to the real time ultrasound measurements. After needling or sham&#xD;
      intervention is complete, the original researchers will return to re-measure transversus&#xD;
      abdominis. They will be blind to intervention allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thickness of transversus abdominis at rest and during contraction</measure>
    <time_frame>1 day</time_frame>
    <description>Real time ultrasound measurement</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Monofilament needles will be inserted into each subject's left multifidus muscle and stimulated mechanically for a local twitch response</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham needling</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Monofilament tubes will be pressed into the left multifidus muscle and mechanically manipulated to give the sensation that needling is occuring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Sterile monofilament needles</description>
    <arm_group_label>Dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham needling</intervention_name>
    <description>Applicator tubes from the sterile monofilament needles</description>
    <arm_group_label>Sham needling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age, absence of back pain or symptoms for greater than 6 months and ability to perform&#xD;
             DCC. Subjects must also report they are comfortable with being 'needled'.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of back pain or symptoms within the last 6 months, history of: abdominal or&#xD;
             spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia,&#xD;
             active ankylosing spondylitis. If a subject reports a fear of needles.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniella Morton, BSc</last_name>
    <role>Study Director</role>
    <affiliation>University of Nevada Las Vegas Physical Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Buckingham, BSc</last_name>
    <role>Study Director</role>
    <affiliation>University of Nevada Las Vegas Physical Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Crystal Montoya, BSc</last_name>
    <role>Study Director</role>
    <affiliation>Univesity of Nevada Las Vegas Physical Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nevada Las Vegas - Department of Physical Therapy</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>June 17, 2013</last_update_submitted>
  <last_update_submitted_qc>June 17, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Emilio</investigator_full_name>
    <investigator_title>Dr. Emilio J. Puentedura</investigator_title>
  </responsible_party>
  <keyword>Back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</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/NCT01734577
org study id: UNLVPT-4059
nct id: NCT01734577
lead sponsor: 
has dmc: No
Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of
      musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine
      for a neurophysiological effect.
Consenting adults will be taught how to contract their abdominal muscles, and to contract
      transversus abdominis in particular. They will then have real time ultrasound measurements of
      the resting and contracted thickness of their left transversus abdominis muscle. After this,
      they will receive actual or sham needling to their left multifidus muscle by another
      researchers blinded to the real time ultrasound measurements. After needling or sham
      intervention is complete, the original researchers will return to re-measure transversus
      abdominis. They will be blind to intervention allocation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Thickness of transversus abdominis at rest and during contraction
time frame: 1 day
description: Real time ultrasound measurement
arm group label: Dry needling
arm group type: Active Comparator
description: Monofilament needles will be inserted into each subject's left multifidus muscle and stimulated mechanically for a local twitch response
arm group label: Sham needling
arm group type: Sham Comparator
description: Monofilament tubes will be pressed into the left multifidus muscle and mechanically manipulated to give the sensation that needling is occuring.
intervention type: Procedure
intervention name: Dry needling
description: Sterile monofilament needles
arm group label: Dry needling
intervention type: Procedure
intervention name: Sham needling
description: Applicator tubes from the sterile monofilament needles
arm group label: Sham needling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniella Morton, BSc
role: Study Director
affiliation: University of Nevada Las Vegas Physical Therapy
last name: Sarah Buckingham, BSc
role: Study Director
affiliation: University of Nevada Las Vegas Physical Therapy
last name: Crystal Montoya, BSc
role: Study Director
affiliation: Univesity of Nevada Las Vegas Physical Therapy
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Emilio
investigator title: Dr. Emilio J. Puentedura
mesh term: Back Pain