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/NCT06023836</url>
    </required_header>
    <id_info>
      <org_study_id>07/04/2023; 2011-KAEK-50;89</org_study_id>
      <nct_id>NCT06023836</nct_id>
    </id_info>
    <brief_title>Myofascial Pain Syndrome and Plantar Fasciitis Treatment</brief_title>
    <official_title>Myofascial Pain Syndrome in Plantar Fasciitis; Comparison of Dry Needling and Extracorporeal Shockwave Therapy (ESWT) Effects on Pain and Function</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>
        Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical&#xD;
        Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and&#xD;
        exclusion criteria will be included in the study. Demographic data (age, gender, body mass&#xD;
        index, symptom duration) will be recorded at the beginning of the study. Then, Foot&#xD;
        Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants&#xD;
        will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will&#xD;
        receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3&#xD;
        sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week&#xD;
        intervals for the trigger point detected by manual palpation in the medial gastrocnemius,&#xD;
        lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis&#xD;
        brevis muscles. Patients in the 2nd group will receive 3 sessions of ESWT (MASTERPLUS MP 200&#xD;
        ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a&#xD;
        week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal&#xD;
        shares of 2500 pulses.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">September 8, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 28, 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>
      <intervention_model_description>Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain was evaluated with a Visual analog scale (VAS) score.</measure>
      <time_frame>5 months</time_frame>
      <description>VAS score ranges from 0 to 10.&#xD;
  Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Function was evaluated with (Foot Functional Index) FFI score.</measure>
      <time_frame>5 months</time_frame>
      <description>Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Plantar Fascitis</condition>
    <condition>Myofascial Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>group 1: ESWT treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this group will only receive ESWT treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry needling</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this group will only receive Dry needling treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ESWT</intervention_name>
      <description>Patients in the group will receive 3 sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal shares of 2500 pulses.</description>
      <arm_group_label>group 1: ESWT treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dry needling</intervention_name>
      <description>Dry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group.</description>
      <arm_group_label>Dry needling</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 25-65 years with heel pain for more than 6 weeks&#xD;
  &#xD;
            -  tenderness on palpation in the medial calcaneal region&#xD;
  &#xD;
            -  aggravation of symptoms while standing and in the first hours of the morning&#xD;
  &#xD;
            -  who agreed not to receive anti-inflammatory treatment during the study period&#xD;
  &#xD;
            -  fascia thickness &gt;4mm measured by ultrasound.&#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;
            -  Anti-inflammatory-analgesic treatment within the last 1 month&#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;
            -  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;
  &#xD;
            -  Those with bleeding disorders&#xD;
  &#xD;
            -  Pregnant women&#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>+90 539 342 66 68</phone>
      <email>drbrk22.94@gmail.com</email>
    </overall_contact>
    <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 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 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>
    <keyword>plantar fasciitis</keyword>
    <keyword>ESWT</keyword>
    <keyword>dry needling</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fasciitis</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
      <mesh_term>Fasciitis, Plantar</mesh_term>
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06023836
  org study id: 07/04/2023; 2011-KAEK-50;89
  nct id: NCT06023836
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical
        Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and
        exclusion criteria will be included in the study. Demographic data (age, gender, body mass
        index, symptom duration) will be recorded at the beginning of the study. Then, Foot
        Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants
        will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will
        receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3
        sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week
        intervals for the trigger point detected by manual palpation in the medial gastrocnemius,
        lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis
        brevis muscles. Patients in the 2nd group will receive 3 sessions of ESWT (MASTERPLUS MP 200
        ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a
        week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal
        shares of 2500 pulses.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain was evaluated with a Visual analog scale (VAS) score.
  time frame: 5 months
  description: VAS score ranges from 0 to 10.
  Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis
  measure: Function was evaluated with (Foot Functional Index) FFI score.
  time frame: 5 months
  description: Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis
  arm group label: group 1: ESWT treatment
  arm group type: Active Comparator
  description: Participants in this group will only receive ESWT treatment
  arm group label: Dry needling
  arm group type: Active Comparator
  description: Participants in this group will only receive Dry needling treatment
  intervention type: Device
  intervention name: ESWT
  description: Patients in the group will receive 3 sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal shares of 2500 pulses.
  arm group label: group 1: ESWT treatment
  intervention type: Procedure
  intervention name: Dry needling
  description: Dry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group.
  arm group label: Dry needling
  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: +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: Fasciitis
  mesh term: Myofascial Pain Syndromes
  mesh term: Fasciitis, Plantar
  mesh term: Fibromyalgia
  mesh term: Syndrome
  mesh term: Somatoform Disorders