<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/NCT02250742</url>
  </required_header>
  <id_info>
    <org_study_id>045/11</org_study_id>
    <nct_id>NCT02250742</nct_id>
  </id_info>
  <brief_title>The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients</brief_title>
  <official_title>The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Haifa</source>
  <brief_summary>
    <textblock>
      The study will establish data on the function of trunk muscles in healthy and low back pain&#xD;
      patient's pre and post dry needling treatment. This will help in understanding the underlying&#xD;
      mechanism of this treatment and reveal the effect of dry needling on muscle performance.&#xD;
&#xD;
      Study hypothesis is that an improvement of back muscle function following dry needling&#xD;
      procedure will be found.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry needling of muscles is mainly used for the management of pain in musculoskeletal&#xD;
      disorders. Yet, the association between dry needling and motor performance of muscles is&#xD;
      still unclear.&#xD;
&#xD;
      This study aims to investigate the immediate effect of dry needling on lumbar multifidus&#xD;
      muscles' function in healthy and low back pain subjects.&#xD;
&#xD;
      The sample will be divided into: low back pain group and control (healthy) group. Both groups&#xD;
      will receive dry needling to the lumbar multifidus muscles using a deep insertion technique&#xD;
      with 4 needles (2 on each side of the spine). The needles will be left in situ for 10&#xD;
      minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and&#xD;
      post- procedure during rest in a prone position and during contralateral active straight leg&#xD;
      extension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Multifidus muscle thickness</measure>
    <time_frame>baseline and Immediately after dry needling procedure at the same session</time_frame>
    <description>Multifidus muscle thickness will be measured using diagnostic ultrasound imaging</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>low back pain group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utielized. The needles will be left in situ for 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utilized. The needles will be left in situ for 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dry needling</intervention_name>
    <description>Dry needling uses traditional acupuncture needles without injecting any liquid. Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.</description>
    <arm_group_label>healthy group</arm_group_label>
    <arm_group_label>low back pain group</arm_group_label>
    <other_name>acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-60 years.&#xD;
&#xD;
          -  Healthy individuals or individuals with main complaint of low back pain (LBP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with &quot;red flags&quot; for a serious spinal condition, for example: tumor,&#xD;
             compression fractures, infection, cancer.&#xD;
&#xD;
          -  Signs of nerve root compression (positive straight leg raise &lt;45 degrees, decreased&#xD;
             reflexes, decrease sensation or decreased strength in the lower extremities).&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Previous surgery to the lumbar spine&#xD;
&#xD;
          -  History of congenital lumbar or pelvic anomalies&#xD;
&#xD;
          -  Physical therapy for LBP was provided in the 6 months prior to participation in the&#xD;
             study&#xD;
&#xD;
          -  Patients who are unable to lie prone for 30 minutes.&#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>Gali Dar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Haifa, Department of Physical Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Haifa</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>May 21, 2016</last_update_submitted>
  <last_update_submitted_qc>May 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Haifa</investigator_affiliation>
    <investigator_full_name>Gali Dar</investigator_full_name>
    <investigator_title>PhD, researcher</investigator_title>
  </responsible_party>
  <keyword>ultrasound imaging</keyword>
  <keyword>acupuncture</keyword>
  <keyword>back muscles</keyword>
  <keyword>spine</keyword>
  <keyword>muscle strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low 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/NCT02250742
org study id: 045/11
nct id: NCT02250742
lead sponsor: 
The study will establish data on the function of trunk muscles in healthy and low back pain
      patient's pre and post dry needling treatment. This will help in understanding the underlying
      mechanism of this treatment and reveal the effect of dry needling on muscle performance.

      Study hypothesis is that an improvement of back muscle function following dry needling
      procedure will be found.
Dry needling of muscles is mainly used for the management of pain in musculoskeletal
      disorders. Yet, the association between dry needling and motor performance of muscles is
      still unclear.

      This study aims to investigate the immediate effect of dry needling on lumbar multifidus
      muscles' function in healthy and low back pain subjects.

      The sample will be divided into: low back pain group and control (healthy) group. Both groups
      will receive dry needling to the lumbar multifidus muscles using a deep insertion technique
      with 4 needles (2 on each side of the spine). The needles will be left in situ for 10
      minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and
      post- procedure during rest in a prone position and during contralateral active straight leg
      extension.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Multifidus muscle thickness
time frame: baseline and Immediately after dry needling procedure at the same session
description: Multifidus muscle thickness will be measured using diagnostic ultrasound imaging
arm group label: low back pain group
arm group type: Experimental
description: Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utielized. The needles will be left in situ for 10 minutes.
arm group label: healthy group
arm group type: Active Comparator
description: Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utilized. The needles will be left in situ for 10 minutes.
intervention type: Other
intervention name: dry needling
description: Dry needling uses traditional acupuncture needles without injecting any liquid. Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.
arm group label: healthy group
arm group label: low back pain group
other name: acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gali Dar, PhD
role: Principal Investigator
affiliation: University of Haifa, Department of Physical Therapy
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: University of Haifa
investigator full name: Gali Dar
investigator title: PhD, researcher
mesh term: Back Pain
mesh term: Low Back Pain