<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/NCT04400825</url>
  </required_header>
  <id_info>
    <org_study_id>CEIm1955</org_study_id>
    <nct_id>NCT04400825</nct_id>
  </id_info>
  <brief_title>Dry Needling Versus Stretching for Muscle Extensibility</brief_title>
  <official_title>Comparing Dry Needling and Stretching for the Management of Muscle Extensibility in Patients With Hip Osteoarthritis: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>No</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>
      Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently&#xD;
      several authors have shown the presence of active myofascial trigger points (MTrP) in the&#xD;
      muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.&#xD;
&#xD;
      Despite of the beneficial effects that have shown may conservative non-pharmacological&#xD;
      treatments, there is a lack of studies evaluating the effects of the conservative treatments&#xD;
      on muscle extensibility.&#xD;
&#xD;
      According to the new paradigm about the presence of MTrPs, the investigators decided to&#xD;
      conduct a randomized clinical trial to compare the effects of DN intervention and stretching&#xD;
      protocol on muscle extensibility in patients with hip OA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">July 19, 2020</completion_date>
  <primary_completion_date type="Actual">July 19, 2020</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>
    <intervention_model_description>randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>single-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>muscle extensibility</measure>
    <time_frame>Baseline</time_frame>
    <description>the examiners assess the muscle extensibility using an inclinomenter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle extensibility</measure>
    <time_frame>up to 3 weeks</time_frame>
    <description>the examiners assess the muscle extensibility using an inclinomenter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stiffness</measure>
    <time_frame>Baseline</time_frame>
    <description>the examiners assess the stiffness using the WOMAC stiffness subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stiffness</measure>
    <time_frame>up to 3 weeks</time_frame>
    <description>the examiners assess the stiffness using the WOMAC stiffness subscale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dry needling of 3 active MTrPs at most.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stretching of the main hip flexors (rectus femoris, iliopsoas and tensor fasciae latae)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Dry needling of the active MTrPs following the technique described by Hong et al (1994,1995)</description>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_label>Stretching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral hip OA diagnosed medically with a X-Ray tess and following the American&#xD;
             College of Rheumatology Criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic&#xD;
             disease, congenital diseases etc.&#xD;
&#xD;
          -  Vascular or neurological disease.&#xD;
&#xD;
          -  Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs&#xD;
&#xD;
          -  DN contraindications or fear of needles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Luis Ceballos Laita</name>
      <address>
        <city>Soria</city>
        <zip>42004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>Luis Ceballos Laita</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <keyword>physiotherapy</keyword>
  <keyword>stretching</keyword>
  <keyword>dry needling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04400825
org study id: CEIm1955
nct id: NCT04400825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently
      several authors have shown the presence of active myofascial trigger points (MTrP) in the
      muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.

      Despite of the beneficial effects that have shown may conservative non-pharmacological
      treatments, there is a lack of studies evaluating the effects of the conservative treatments
      on muscle extensibility.

      According to the new paradigm about the presence of MTrPs, the investigators decided to
      conduct a randomized clinical trial to compare the effects of DN intervention and stretching
      protocol on muscle extensibility in patients with hip OA.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized clinical trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: single-blind
measure: muscle extensibility
time frame: Baseline
description: the examiners assess the muscle extensibility using an inclinomenter
measure: muscle extensibility
time frame: up to 3 weeks
description: the examiners assess the muscle extensibility using an inclinomenter
measure: Stiffness
time frame: Baseline
description: the examiners assess the stiffness using the WOMAC stiffness subscale
measure: Stiffness
time frame: up to 3 weeks
description: the examiners assess the stiffness using the WOMAC stiffness subscale
arm group label: Dry needling
arm group type: Experimental
description: Dry needling of 3 active MTrPs at most.
arm group label: Stretching
arm group type: Active Comparator
description: Stretching of the main hip flexors (rectus femoris, iliopsoas and tensor fasciae latae)
intervention type: Other
intervention name: Dry needling
description: Dry needling of the active MTrPs following the technique described by Hong et al (1994,1995)
arm group label: Dry needling
arm group label: Stretching
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: Luis Ceballos Laita
investigator title: Ph.D
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
sharing ipd: No