<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/NCT03248986</url>
  </required_header>
  <id_info>
    <org_study_id>1.0</org_study_id>
    <nct_id>NCT03248986</nct_id>
  </id_info>
  <brief_title>Dry Needling in Stroke to Improve the Upper Limb Functionality</brief_title>
  <official_title>Effectiveness of Dry Needling in Improving the Functionality of the Affected Arm in the Patient With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guadarrama Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of San Jorge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guadarrama Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A single-center, observational, prospective, single dynamic cohort study with before-after&#xD;
      design. Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for&#xD;
      Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with&#xD;
      stroke. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS),&#xD;
      functionality with the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom&#xD;
      Stages Scale (BSS) and upper limb spasticity pattern (ULP), pain by 10-points Numerical&#xD;
      Rating Scale (NRS10) and the quality of life with the Euro QoL 5D survey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once each patient has signed the informed consent document and it has been verified that the&#xD;
      inclusion criteria are met, it will be assigned the same identification number (ID) that is&#xD;
      related to its Clinical History (CH) by simple coding; custody of the file with the&#xD;
      relationship of each ID with its CH will be the responsibility of the principal investigator.&#xD;
&#xD;
      Patients admitted to the Guadarrama Hospital with the diagnosis of stroke and who meet the&#xD;
      eligibility criteria will be treated by their usual physiotherapist, who will administer the&#xD;
      standard dry needling intervention.&#xD;
&#xD;
      Patients will receive 6 sessions of DNHS® technique with an interval of 1 week between each&#xD;
      session (1st to 4th sessions) and every 15 days (5th and 6th sessions). The procedure will be&#xD;
      applied according to the corresponding protocols established in the NWPs (Normalized Work&#xD;
      Plans) used in the usual clinical practice in the Guadarrama Hospital.&#xD;
&#xD;
      The DNHS® technique is specifically indicated for the treatment of spasticity. This technique&#xD;
      differs from that usually used to relieve pain and deactivate myofascial trigger points&#xD;
      (MTPs). The muscles to be treated are placed in a submaximum stretching position; the&#xD;
      evaluation criteria when defining the needle insertion zone are based on finding an increase&#xD;
      in modularity and muscle activity in the area when the muscle undergoes rapid stretching.&#xD;
      Once the area to be treated is located, the needle is inserted and moves between 0.5 and 1 cm&#xD;
      in / deep and fan out / surface to cause a local or global spasm reaction. Treatment ceases&#xD;
      when the frequency of these responses decreases markedly or disappears. If the patient feels&#xD;
      &quot;not tolerable&quot; pain (some discomfort from the dry needling is usual), you can stop the&#xD;
      treatment at any time.&#xD;
&#xD;
      Before and after each dry needling session patients will be evaluated by their usual&#xD;
      physiotherapist, using the upper limb block of the Fugl-Meyer scale that assesses motor&#xD;
      skills and sensitivity of the affected arm, evaluation of pain through NRS10 and assessment&#xD;
      of spasticity of muscles to be treated by MMAS. Also, at the beginning, in the 4th session&#xD;
      and at the end of the study, the Euro-QoL 5D-5L quality of life survey will be administered,&#xD;
      with a license for use. In adition BSS and ULP will be evaluated at the begining and at the&#xD;
      end of the study. In each dry needling session, the caliber of the needle used, the number of&#xD;
      fast-in and fast-out of the needle and the number of the spasm reactions caused for the&#xD;
      purpose of establishing the dose pattern shall be recorded for each treated muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>8 Weeks</target_duration>
  <primary_outcome>
    <measure>Fugl-Meyer Upper Limb Scale.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Evaluation of the functionality of the affected arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modification of Modified Ashworth Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessment of spasticity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euro QoL 5D quality of life scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Quiality of life evaluation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Numerical Rating Scale 10-points scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Pain evaluation</description>
  </other_outcome>
  <other_outcome>
    <measure>Brunnstrom Recovery Stages</measure>
    <time_frame>8 weeks</time_frame>
    <description>Upper limb motor recovery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Upper limb pattern</measure>
    <time_frame>8 weeks</time_frame>
    <description>Upper limb spastic pattern.</description>
  </other_outcome>
  <enrollment type="Actual">51</enrollment>
  <condition>Spasticity, Muscle</condition>
  <condition>Functionality</condition>
  <condition>Quality of Life</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Dry needling of the spastic muscles of the affected arm through DNHS®.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with the diagnosis of stroke entering for the first time at the Hospital&#xD;
        Guadarrama&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  They must voluntarily understand and sign the relevant informed consent documents and&#xD;
             information sheet, before any evaluation / procedure related to the study is&#xD;
             conducted.&#xD;
&#xD;
          -  Male or female, ≥ 18 years old at the time of consent.&#xD;
&#xD;
          -  Have the diagnosis of hemispheric ischemic or hemorrhagic stroke without excluding&#xD;
             other causes (surgical, traumatic, etc ...).&#xD;
&#xD;
          -  Show spasticity in the affected upper limb, with an MMAS score of 1-3 in one of the&#xD;
             following muscle groups: finger flexors, wrist flexors, elbow flexors, forearm&#xD;
             pronators, adductors, or internal rotators of the shoulder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of stiffness (score of 4 in MMAS) or hypotonia (MMAS of 0).&#xD;
&#xD;
          -  Severe cognitive impairment, severe language problems, severe vision or hearing&#xD;
             impairments that prevent compression and active patient collaboration during&#xD;
             evaluation tests.&#xD;
&#xD;
          -  Have received treatment by injection of TBA in the 2 months prior to the start of the&#xD;
             study.&#xD;
&#xD;
          -  Any medical condition that contraindicates dry needling.&#xD;
&#xD;
          -  Present some contraindication for the application of dry puncture: Pregnancy,&#xD;
             insurmountable fear of needles, allergy to metals (nickel), presence of lesions in the&#xD;
             puncture area, scars, tattoos...&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Nicolas Cuenca Zaldivar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guadarrama Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>J.Nicolas Cuenca Zaldivar</name>
      <address>
        <city>Guadarrama</city>
        <state>Madrid</state>
        <zip>28440</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guadarrama Hospital</investigator_affiliation>
    <investigator_full_name>J. Nicolas Cuenca Zaldivar</investigator_full_name>
    <investigator_title>Rehabilitation Service Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</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/NCT03248986
org study id: 1.0
nct id: NCT03248986
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A single-center, observational, prospective, single dynamic cohort study with before-after
      design. Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for
      Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with
      stroke. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS),
      functionality with the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom
      Stages Scale (BSS) and upper limb spasticity pattern (ULP), pain by 10-points Numerical
      Rating Scale (NRS10) and the quality of life with the Euro QoL 5D survey.
Once each patient has signed the informed consent document and it has been verified that the
      inclusion criteria are met, it will be assigned the same identification number (ID) that is
      related to its Clinical History (CH) by simple coding; custody of the file with the
      relationship of each ID with its CH will be the responsibility of the principal investigator.

      Patients admitted to the Guadarrama Hospital with the diagnosis of stroke and who meet the
      eligibility criteria will be treated by their usual physiotherapist, who will administer the
      standard dry needling intervention.

      Patients will receive 6 sessions of DNHS® technique with an interval of 1 week between each
      session (1st to 4th sessions) and every 15 days (5th and 6th sessions). The procedure will be
      applied according to the corresponding protocols established in the NWPs (Normalized Work
      Plans) used in the usual clinical practice in the Guadarrama Hospital.

      The DNHS® technique is specifically indicated for the treatment of spasticity. This technique
      differs from that usually used to relieve pain and deactivate myofascial trigger points
      (MTPs). The muscles to be treated are placed in a submaximum stretching position; the
      evaluation criteria when defining the needle insertion zone are based on finding an increase
      in modularity and muscle activity in the area when the muscle undergoes rapid stretching.
      Once the area to be treated is located, the needle is inserted and moves between 0.5 and 1 cm
      in / deep and fan out / surface to cause a local or global spasm reaction. Treatment ceases
      when the frequency of these responses decreases markedly or disappears. If the patient feels
      "not tolerable" pain (some discomfort from the dry needling is usual), you can stop the
      treatment at any time.

      Before and after each dry needling session patients will be evaluated by their usual
      physiotherapist, using the upper limb block of the Fugl-Meyer scale that assesses motor
      skills and sensitivity of the affected arm, evaluation of pain through NRS10 and assessment
      of spasticity of muscles to be treated by MMAS. Also, at the beginning, in the 4th session
      and at the end of the study, the Euro-QoL 5D-5L quality of life survey will be administered,
      with a license for use. In adition BSS and ULP will be evaluated at the begining and at the
      end of the study. In each dry needling session, the caliber of the needle used, the number of
      fast-in and fast-out of the needle and the number of the spasm reactions caused for the
      purpose of establishing the dose pattern shall be recorded for each treated muscle.
observational model: Cohort
time perspective: Prospective
measure: Fugl-Meyer Upper Limb Scale.
time frame: 8 weeks
description: Evaluation of the functionality of the affected arm
measure: Modification of Modified Ashworth Scale
time frame: 8 weeks
description: Assessment of spasticity
measure: Euro QoL 5D quality of life scale
time frame: 8 weeks
description: Quiality of life evaluation
measure: Numerical Rating Scale 10-points scale
time frame: 8 weeks
description: Pain evaluation
measure: Brunnstrom Recovery Stages
time frame: 8 weeks
description: Upper limb motor recovery.
measure: Upper limb pattern
time frame: 8 weeks
description: Upper limb spastic pattern.
intervention type: Other
intervention name: Dry needling
description: Dry needling of the spastic muscles of the affected arm through DNHS®.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: J. Nicolas Cuenca Zaldivar
role: Principal Investigator
affiliation: Guadarrama Hospital
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Guadarrama Hospital
investigator full name: J. Nicolas Cuenca Zaldivar
investigator title: Rehabilitation Service Principal Investigator
mesh term: Muscle Spasticity
sharing ipd: No