xml: <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/NCT06023823</url>
    </required_header>
    <id_info>
      <org_study_id>07/04/2023; 2011-KAEK-50;88</org_study_id>
      <nct_id>NCT06023823</nct_id>
    </id_info>
    <brief_title>The Role of Dry Needling in Hallux Valgus</brief_title>
    <official_title>Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Training and Research Hospital</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>
        Forty Hallux valgus patients between the ages of 25-65 years, who are admitted to the&#xD;
        Physical Medicine and Rehabilitation clinic with the complaint of 1st Metatarsophalangeal&#xD;
        (MTF) pain and who meet the inclusion and exclusion criteria will be included. Hallux valgus&#xD;
        (HV) angles will be measured by dorsoplantar radiography before the patients start the study.&#xD;
        The HV angle was measured as the angle between the bisection line of the first metatarsal&#xD;
        bone and the first proximal phalanx. Demographic data (age, gender, body mass index) will be&#xD;
        recorded at the beginning of the study. Then, the initial Foot Functional Index (FFI) and&#xD;
        Visual Analog Scale (VAS) scales were completed. The 1st MTF joint angle was also measured&#xD;
        with a goniometer and recorded before starting the study. The patients were divided into two&#xD;
        groups. The first group will be given 3 sessions of dry needling with Seirin branded 0.6*50&#xD;
        mm acupuncture needles for trigger point in the abductor hallucis muscle and toe-spread-out&#xD;
        exercise. The second group will receive only toe-spread-out exercises. After starting the&#xD;
        treatment, FFI and VAS scores and 1st MTF angles will be measured and recorded weekly with a&#xD;
        goniometer. At the end of the 3-week treatment, the FFI and VAS scores of the participants&#xD;
        will be re-evaluated after 1 week and 1 month, and the participants will be re-evaluated with&#xD;
        a goniometer. The hallux valgus angle will be re-evaluated with X-ray 4 weeks after the end&#xD;
        of the treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">September 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Does dry needling make an additional contribution to the spread out exercise in the pain management of hallux valgus?</measure>
      <time_frame>Baseline, 3 week, 7 week</time_frame>
      <description>Pain assessment was performed with (Visual Analog Scale) VAS score at baseline, 3.w and 8.w.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Does dry needling make an additional contribution to the spread out exercise in the functional management of hallux valgus?</measure>
      <time_frame>Baseline, 3 week, 7 week</time_frame>
      <description>Function assessment was performed with (Foot Functional INdex) FFI score at baseline, 3.w and 8.w.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Does dry needling provide an additional contribution to the spread out exercise in the hallux valgus angle?</measure>
      <time_frame>Baseline, 7 week</time_frame>
      <description>The hallux valgus angle will be measured at baseline and 7.w on direct radiographs.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hallux Valgus</condition>
    <condition>Myofascial Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>Toe spread out treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry needling</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Toe spread out</intervention_name>
      <description>toe-spread-out exercise.</description>
      <arm_group_label>Toe spread out treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dry needling+Toe spread out</intervention_name>
      <description>The group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger pointe in the abductor hallucis muscle and additionally toe-spread-out exercise.</description>
      <arm_group_label>Dry needling</arm_group_label>
      <arm_group_label>Toe spread out treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  25-65 years old with pain for more than 4 weeks&#xD;
  &#xD;
            -  Hallux valgus angle between 20-40 degrees&#xD;
  &#xD;
            -  VAS value above 4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with rheumatologic diseases&#xD;
  &#xD;
            -  Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney&#xD;
               failure&#xD;
  &#xD;
            -  Those who received anti-inflammatory-analgesic treatment in the last 1 week&#xD;
  &#xD;
            -  Diagnosed with inflammatory rheumatic disease&#xD;
  &#xD;
            -  Those with a history of foot surgery&#xD;
  &#xD;
            -  Those with mid or hindfoot deformity&#xD;
  &#xD;
            -  Those with 1st MTF joint problems other than hallux valgus&#xD;
  &#xD;
            -  Those with a history of orthotic use&#xD;
  &#xD;
            -  Previous history of central or peripheral nerve damage, lower extremity neuropathy&#xD;
  &#xD;
            -  Those diagnosed with Diabetes Mellitus&#xD;
  &#xD;
            -  Those with cognitive impairment&#xD;
  &#xD;
            -  Unassisted mobilization&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Burak Tayyip Dede</last_name>
      <role>Principal Investigator</role>
      <affiliation>İstanbul Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Burak Tayyip Dede</last_name>
      <phone>05393426668</phone>
      <email>drbrk22.94@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Burak Tayyip Dede</last_name>
      <phone>+90 539 342 66 68</phone>
      <email>drbrk22.94@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istanbul Training and Resarch Hospital</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Burak Tayyip DEDE</last_name>
        <phone>05393426668</phone>
        <email>drbrk22.94@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Burak Tayyip Dede</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Hallux Valgus</mesh_term>
      <mesh_term>Bunion</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023823
  org study id: 07/04/2023; 2011-KAEK-50;88
  nct id: NCT06023823
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Forty Hallux valgus patients between the ages of 25-65 years, who are admitted to the
        Physical Medicine and Rehabilitation clinic with the complaint of 1st Metatarsophalangeal
        (MTF) pain and who meet the inclusion and exclusion criteria will be included. Hallux valgus
        (HV) angles will be measured by dorsoplantar radiography before the patients start the study.
        The HV angle was measured as the angle between the bisection line of the first metatarsal
        bone and the first proximal phalanx. Demographic data (age, gender, body mass index) will be
        recorded at the beginning of the study. Then, the initial Foot Functional Index (FFI) and
        Visual Analog Scale (VAS) scales were completed. The 1st MTF joint angle was also measured
        with a goniometer and recorded before starting the study. The patients were divided into two
        groups. The first group will be given 3 sessions of dry needling with Seirin branded 0.6*50
        mm acupuncture needles for trigger point in the abductor hallucis muscle and toe-spread-out
        exercise. The second group will receive only toe-spread-out exercises. After starting the
        treatment, FFI and VAS scores and 1st MTF angles will be measured and recorded weekly with a
        goniometer. At the end of the 3-week treatment, the FFI and VAS scores of the participants
        will be re-evaluated after 1 week and 1 month, and the participants will be re-evaluated with
        a goniometer. The hallux valgus angle will be re-evaluated with X-ray 4 weeks after the end
        of the treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Does dry needling make an additional contribution to the spread out exercise in the pain management of hallux valgus?
  time frame: Baseline, 3 week, 7 week
  description: Pain assessment was performed with (Visual Analog Scale) VAS score at baseline, 3.w and 8.w.
  measure: Does dry needling make an additional contribution to the spread out exercise in the functional management of hallux valgus?
  time frame: Baseline, 3 week, 7 week
  description: Function assessment was performed with (Foot Functional INdex) FFI score at baseline, 3.w and 8.w.
  measure: Does dry needling provide an additional contribution to the spread out exercise in the hallux valgus angle?
  time frame: Baseline, 7 week
  description: The hallux valgus angle will be measured at baseline and 7.w on direct radiographs.
  arm group label: Toe spread out treatment
  arm group type: Active Comparator
  arm group label: Dry needling
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Toe spread out
  description: toe-spread-out exercise.
  arm group label: Toe spread out treatment
  intervention type: Other
  intervention name: Dry needling+Toe spread out
  description: The group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger pointe in the abductor hallucis muscle and additionally toe-spread-out exercise.
  arm group label: Dry needling
  arm group label: Toe spread out treatment
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Burak Tayyip Dede
  role: Principal Investigator
  affiliation: İstanbul Training and Research Hospital
  last name: Burak Tayyip Dede
  phone: 05393426668
  email: drbrk22.94@gmail.com
  last name: Burak Tayyip Dede
  phone: +90 539 342 66 68
  email: drbrk22.94@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Training and Research Hospital
  investigator full name: Burak Tayyip Dede
  investigator title: Medical Doctor
  mesh term: Myofascial Pain Syndromes
  mesh term: Fibromyalgia
  mesh term: Hallux Valgus
  mesh term: Bunion
  sharing ipd: Yes