<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/NCT04435561</url>
  </required_header>
  <id_info>
    <org_study_id>UMADryNeed</org_study_id>
    <nct_id>NCT04435561</nct_id>
  </id_info>
  <brief_title>Efficacy of Dry Needling in the Spasticity Post-stroke</brief_title>
  <acronym>DNSpasticity</acronym>
  <official_title>Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaga</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>
      Stroke is a serious clinical condition and one of the leading causes of long-term disability&#xD;
      in the world. One of the most serious complications of this condition is spasticity.&#xD;
      Recently, dry needling has commented to be used as a treatment in muscle spasticity of&#xD;
      chronic patients after a stroke, producing improvements in clinical conditions.&#xD;
&#xD;
      This study evaluates the effectiveness of dry needling technique in the spasticity of the&#xD;
      hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to&#xD;
      measure the spasticity´s improvement after the procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2021</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in spasticity</measure>
    <time_frame>Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.</time_frame>
    <description>The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement.&#xD;
The scale goes from 0 to 4 points. The higher the score, the greater the impact.&#xD;
Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).&#xD;
Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in range of motion</measure>
    <time_frame>Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.</time_frame>
    <description>Active and passive range of motion of the shoulder and ankle will be measure with an standard goniometer. Each movement will be evaluated three times, and the average of theses three results will be performed. The same procedure will be followed to measure both active and passive range of motion of each patient.&#xD;
Experimental group: Range of motion will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).&#xD;
Control group: Range of motion will be measure at the beginning of the week (before usual therapy) and at the end of the week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Motor function of the upper and lower limb</measure>
    <time_frame>Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.</time_frame>
    <description>Fugl-Meyer Scale is one of the most complete quantitative measures designed to measure disability after a stroke. It is divided into five domains and each domain has other elements that are evaluated on an ordinal scale of 0 to 2 points.&#xD;
The upper and lower limb motor assessment will be used, with a maximum of 100 points, 66 and 34 respectively, and a minimum of 0 points. The lower the score, the greater the impact.&#xD;
Fugl-Meyer Arm Motor Assessment will be use to evaluate motor function of the upper hemiparetic limb and the Fugl-Meyer Motor Leg Assessment to evaluate motor function of the lower hemiparetic limb.&#xD;
Experimental group: Motor function will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).&#xD;
Control group: Motor function will be measure at the beginning of the week (before usual therapy) and at the end of the week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Gait</measure>
    <time_frame>Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.</time_frame>
    <description>The gait will be measure with the Wisconsin Gait Scale. Gait in hemiparetic patients after a stroke must be safe and efficient. Wisconsin Gait Scale is an instrument used to measure gait problems experienced by patients who have hemiplegia after a stroke. This scale can be used as a tool to determine the effectiveness of rehabilitation training and observe how the patient develops in the different phases of gait.&#xD;
The maximum score is 42 points and the minimum 13.35 points. The higher the score, the greater the patient´s gait involvement.&#xD;
Experimental group: Gait will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).&#xD;
Control group: Gait will be measure at the beginning of the week (before usual therapy) and at the end of the week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Physical disability</measure>
    <time_frame>Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.</time_frame>
    <description>Barthel Index will be used to measure physical disability. It is a widely used instrument to measure the ability of a person to perform daily activities. This tool assesses the independence of the patient to carry out theses activities with or without help. Thanks to this tool, the dependency´s degree can be estimated quantitatively.&#xD;
The maximum score is 100 points and the minimum is 0. The higher the score, the more independence the subject will have.&#xD;
Experimental group: Physical disability will be measure only before the treatment (is the only one that won´t be measure after each session) of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).&#xD;
Control group: Physical disability will be measure at the beginning of the week (before usual therapy) and at the end of the week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Spasticity, Muscle</condition>
  <arm_group>
    <arm_group_label>Standard physiotherapy rehabilitation and dry needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the usual therapy, the experimental group will receive the application of dry needling technique in the hemiparetic limbs.&#xD;
Dry needling intervention will take place over a period of one and a half months (6 weeks), with a total of 6 sessions. Each session will be performed once a week, where a single puncture will be made in each muscle to be treated, using Hong´s technique and lasting 60 seconds per muscle (or until the muscle is release).&#xD;
The muscles that will receive dry needling are the following ones:&#xD;
Upper limb: infraspinatus, teres minor, pectoralis major, deltoid.&#xD;
Lower limb: gastrocnemius, soleus and anterior tibial muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard physiotherapy rehabilitation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will receive the usual therapy and treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard physiotherapy rehabilitation and dry needling</intervention_name>
    <description>The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.</description>
    <arm_group_label>Standard physiotherapy rehabilitation and dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard physiotherapy rehabilitation</intervention_name>
    <description>This group receives their traditional intervention, without dry needling.</description>
    <arm_group_label>Standard physiotherapy rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First hemiplegic ischemic stroke.&#xD;
&#xD;
          -  Chronic stroke (stroke at least 6 months before the trial).&#xD;
&#xD;
          -  Present a level of spasticity equal or greater than 1 according to the Modified&#xD;
             Asworth Scale.&#xD;
&#xD;
          -  Preserve cognitive capacity.&#xD;
&#xD;
          -  Being able to understand and follow simple instructions.&#xD;
&#xD;
          -  Not afraid of needles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent stroke.&#xD;
&#xD;
          -  Subjects with cognitive disorders.&#xD;
&#xD;
          -  Presenting any medical contraindication for the dry needling procedure or problems&#xD;
             with coagulation or epilepsy.&#xD;
&#xD;
          -  Alteration of sensitivity.&#xD;
&#xD;
          -  Receives nerve block or botulinum toxin treatments in a period equal or less than 6&#xD;
             months, since ir can modify the results.&#xD;
&#xD;
          -  Hemorrhagic stroke.&#xD;
&#xD;
          -  Subjects who do not consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rocío Martin Valero, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Antonio Armenta Peinado, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rocío Martín Valero, PhD</last_name>
    <phone>34 951 95 28 58</phone>
    <email>rovalemas@uma.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angela Ramos Villodres</last_name>
    <email>angeramosvillodres@gmail.com</email>
  </overall_contact_backup>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Rocío Martín Valero</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>dry needling</keyword>
  <keyword>spasticity</keyword>
  <keyword>hypertonia</keyword>
  <keyword>stroke</keyword>
  <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/NCT04435561
org study id: UMADryNeed
nct id: NCT04435561
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stroke is a serious clinical condition and one of the leading causes of long-term disability
      in the world. One of the most serious complications of this condition is spasticity.
      Recently, dry needling has commented to be used as a treatment in muscle spasticity of
      chronic patients after a stroke, producing improvements in clinical conditions.

      This study evaluates the effectiveness of dry needling technique in the spasticity of the
      hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to
      measure the spasticity´s improvement after the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Changes in spasticity
time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
description: The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement.
The scale goes from 0 to 4 points. The higher the score, the greater the impact.
Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.
measure: Changes in range of motion
time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
description: Active and passive range of motion of the shoulder and ankle will be measure with an standard goniometer. Each movement will be evaluated three times, and the average of theses three results will be performed. The same procedure will be followed to measure both active and passive range of motion of each patient.
Experimental group: Range of motion will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Range of motion will be measure at the beginning of the week (before usual therapy) and at the end of the week.
measure: Changes in Motor function of the upper and lower limb
time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
description: Fugl-Meyer Scale is one of the most complete quantitative measures designed to measure disability after a stroke. It is divided into five domains and each domain has other elements that are evaluated on an ordinal scale of 0 to 2 points.
The upper and lower limb motor assessment will be used, with a maximum of 100 points, 66 and 34 respectively, and a minimum of 0 points. The lower the score, the greater the impact.
Fugl-Meyer Arm Motor Assessment will be use to evaluate motor function of the upper hemiparetic limb and the Fugl-Meyer Motor Leg Assessment to evaluate motor function of the lower hemiparetic limb.
Experimental group: Motor function will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Motor function will be measure at the beginning of the week (before usual therapy) and at the end of the week.
measure: Changes in Gait
time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
description: The gait will be measure with the Wisconsin Gait Scale. Gait in hemiparetic patients after a stroke must be safe and efficient. Wisconsin Gait Scale is an instrument used to measure gait problems experienced by patients who have hemiplegia after a stroke. This scale can be used as a tool to determine the effectiveness of rehabilitation training and observe how the patient develops in the different phases of gait.
The maximum score is 42 points and the minimum 13.35 points. The higher the score, the greater the patient´s gait involvement.
Experimental group: Gait will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Gait will be measure at the beginning of the week (before usual therapy) and at the end of the week.
measure: Changes in Physical disability
time frame: Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.
description: Barthel Index will be used to measure physical disability. It is a widely used instrument to measure the ability of a person to perform daily activities. This tool assesses the independence of the patient to carry out theses activities with or without help. Thanks to this tool, the dependency´s degree can be estimated quantitatively.
The maximum score is 100 points and the minimum is 0. The higher the score, the more independence the subject will have.
Experimental group: Physical disability will be measure only before the treatment (is the only one that won´t be measure after each session) of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Physical disability will be measure at the beginning of the week (before usual therapy) and at the end of the week.
arm group label: Standard physiotherapy rehabilitation and dry needling
arm group type: Experimental
description: In addition to the usual therapy, the experimental group will receive the application of dry needling technique in the hemiparetic limbs.
Dry needling intervention will take place over a period of one and a half months (6 weeks), with a total of 6 sessions. Each session will be performed once a week, where a single puncture will be made in each muscle to be treated, using Hong´s technique and lasting 60 seconds per muscle (or until the muscle is release).
The muscles that will receive dry needling are the following ones:
Upper limb: infraspinatus, teres minor, pectoralis major, deltoid.
Lower limb: gastrocnemius, soleus and anterior tibial muscles.
arm group label: Standard physiotherapy rehabilitation
arm group type: Other
description: The control group will receive the usual therapy and treatment.
intervention type: Other
intervention name: Standard physiotherapy rehabilitation and dry needling
description: The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.
arm group label: Standard physiotherapy rehabilitation and dry needling
intervention type: Other
intervention name: Standard physiotherapy rehabilitation
description: This group receives their traditional intervention, without dry needling.
arm group label: Standard physiotherapy rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rocío Martin Valero, PhD
role: Principal Investigator
affiliation: University of Malaga
last name: Juan Antonio Armenta Peinado, PhD
role: Study Director
affiliation: University of Malaga
last name: Rocío Martín Valero, PhD
phone: 34 951 95 28 58
email: rovalemas@uma.es
last name: Angela Ramos Villodres
email: angeramosvillodres@gmail.com
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Rocío Martín Valero
investigator title: PhD
mesh term: Muscle Spasticity
sharing ipd: No