<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/NCT03251521</url>
  </required_header>
  <id_info>
    <org_study_id>38RC17.251</org_study_id>
    <nct_id>NCT03251521</nct_id>
  </id_info>
  <brief_title>Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment</brief_title>
  <acronym>DOLOTOX</acronym>
  <official_title>Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      The aim of the study was to analyze which step of the procedure of toxin botulinum injection&#xD;
      is the most painful between skin break-in, electric stimulation, injection and needle&#xD;
      withdrawal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-stroke spasticity management by botulinum toxin injections may be limited by pain or&#xD;
      discomfort at the injection side.&#xD;
&#xD;
      Particularly tracking by electrostimulation, but also skin puncture, toxin injection or&#xD;
      needle withdrawal may be painful.&#xD;
&#xD;
      The objective of this study is to define an individual injection strategy in order to limit&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of pain intensity during injection with botulinum toxin</measure>
    <time_frame>30 min</time_frame>
    <description>Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoesthesia</measure>
    <time_frame>30 min</time_frame>
    <description>Semmes Weinstein Monofilament Evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic pain</measure>
    <time_frame>30 min</time_frame>
    <description>DN4 (Neuropathic pain 4 questions)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Post-stroke Spasticity</condition>
  <arm_group>
    <arm_group_label>spasticity post-stroke</arm_group_label>
    <description>pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pain rating during injection with botulinum toxin</intervention_name>
    <description>The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection</description>
    <arm_group_label>spasticity post-stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients were assessed during routine botulinum toxin injection in the day&#xD;
        clinic of our department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke&#xD;
&#xD;
          -  severe upper or lower limb spasticity (Ashworth score ≥ 2 for at least one muscle)&#xD;
&#xD;
          -  patients requiring a treatment by botulinum toxin&#xD;
&#xD;
          -  patients refusing analgesia for injections.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe aphasia (severity subscore of the BDAE &lt;3)&#xD;
&#xD;
          -  cognitive impairment or psychiatric disease altering the reliability of pain&#xD;
             evaluation&#xD;
&#xD;
          -  patient medically unstable.&#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>Dominic PERENNOU, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>spasticity</keyword>
  <keyword>stroke</keyword>
  <keyword>injection</keyword>
  <keyword>botulinum toxin A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_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/NCT03251521
org study id: 38RC17.251
nct id: NCT03251521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to analyze which step of the procedure of toxin botulinum injection
      is the most painful between skin break-in, electric stimulation, injection and needle
      withdrawal.
Post-stroke spasticity management by botulinum toxin injections may be limited by pain or
      discomfort at the injection side.

      Particularly tracking by electrostimulation, but also skin puncture, toxin injection or
      needle withdrawal may be painful.

      The objective of this study is to define an individual injection strategy in order to limit
      pain.
observational model: Case-Only
time perspective: Retrospective
measure: Evolution of pain intensity during injection with botulinum toxin
time frame: 30 min
description: Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.
measure: Hypoesthesia
time frame: 30 min
description: Semmes Weinstein Monofilament Evaluation
measure: Neuropathic pain
time frame: 30 min
description: DN4 (Neuropathic pain 4 questions)
arm group label: spasticity post-stroke
description: pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale
intervention type: Other
intervention name: pain rating during injection with botulinum toxin
description: The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection
arm group label: spasticity post-stroke
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominic PERENNOU, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Stroke
mesh term: Botulinum Toxins
sharing ipd: No