<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/NCT04476381</url>
  </required_header>
  <id_info>
    <org_study_id>MON07</org_study_id>
    <nct_id>NCT04476381</nct_id>
  </id_info>
  <brief_title>Immediate Effect of Dry Needling on Trigger Points</brief_title>
  <official_title>Immediate Effect of Dry Needling on the Viscoelastic Properties of a Trigger Point on the Infraspinatus Muscle Measured With the MyotonPro</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Sherbrooke</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>
      The immediate effects (0-30 minutes) of a dry needling intervention on a trigger point on&#xD;
      their viscoelastic properties (tone, elasticity and stiffness)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To investigate the immediate effects of a dry needling puncture on the&#xD;
      viscoelastic properties (tone, stiffness and elasticity) of a trigger point (TP) located in&#xD;
      the infraspinatus muscle in participants with non-traumatic chronic shoulder pain.&#xD;
&#xD;
      Methods: Forty-eight individuals who presented non-traumatic chronic shoulder pain were&#xD;
      recruited. The presence of a TP in the infraspinatus muscle of the painful side was confirmed&#xD;
      by an experienced physiotherapist with a palpatory exam according to Travell and Simons&#xD;
      criteria. The TP was marked and the viscoelastic properties including tone, stiffness and&#xD;
      elasticity were measured with the MyotonPro device by an evaluator. After the first set of&#xD;
      measurements (T1), an experienced physiotherapist applied a dry needling puncture to the TP&#xD;
      with a pistoning technique to obtain a local twitch response (LTR) with an Optimed 40 x 0.30&#xD;
      mm single use acupuncture needle. The same set of measurements was repeated immediately after&#xD;
      the dry needling (T2) and 30 minutes later (T3). Repeated measures ANOVA and post-hoc tests&#xD;
      were used to assess changes in viscoelastic properties over time with a significant level set&#xD;
      at 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>One group, one measurement of the viscoelastic properties with the MyotonPro of a single trigger point before the dry needle insertion, one measurement with the MyotonPro right after and 30 minutes later</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tone in Hertz measured with a myotonometer on the trigger point</measure>
    <time_frame>baseline</time_frame>
    <description>Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tone in Hertz measured with a myotonometer on the trigger point</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tone in Hertz measured with a myotonometer on the trigger point</measure>
    <time_frame>30 minutes after the intervention</time_frame>
    <description>Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stiffness in N/m with a myotonometer on the trigger point</measure>
    <time_frame>baseline</time_frame>
    <description>Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stiffness in N/m with a myotonometer on the trigger point</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stiffness in N/m with a myotonometer on the trigger point</measure>
    <time_frame>30 minutes after the intervention</time_frame>
    <description>Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point</measure>
    <time_frame>baseline</time_frame>
    <description>Measurement of the elasticity with the MyotonPro</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Measurement of the elasticity with the MyotonPro</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point</measure>
    <time_frame>30 minutes after the intervention</time_frame>
    <description>Measurement of the elasticity with the MyotonPro</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Dry needling of a trigger point in the infraspinatus muscle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion a a acupuncture type needle into a trigger point in the infraspinatus muscle on the painful side to decrease the stiffness and tone and increase the elasticity</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Insertion of a Optimed 40mm x 0.30 single use, sterile acupuncture needle into a active trigger point in the infraspinatus muscle</description>
    <arm_group_label>Dry needling of a trigger point in the infraspinatus muscle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. present with chronic shoulder pain of non-traumatic origin (rated at least 2/10 on a&#xD;
             numeric rating scale (NRS) for more than 3 months. The pain had to be located in the&#xD;
             shoulder area or referred in the area of the infraspinatus as described by Travell and&#xD;
             Simons (1999);&#xD;
&#xD;
          2. have a hyperirritable spot within a palpable tight band that reproduced the&#xD;
             participant's pain when compressed by palpation; and&#xD;
&#xD;
          3. have a body mass index (BMI) lower than 28&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diagnosis of capsulitis, cancer, or metastasis;&#xD;
&#xD;
          2. previous shoulder or thorax surgery or a mastectomy;&#xD;
&#xD;
          3. shoulder girdle bone fracture;&#xD;
&#xD;
          4. C4-C5 or C6 radiculopathy;&#xD;
&#xD;
          5. known osteoporotic profile (positive bone densitometry);&#xD;
&#xD;
          6. apparent atrophy of the infraspinatus fossa (visual interpretation) and&#xD;
&#xD;
          7. contraindications to receive a DN intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathaly Gaudreault, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Université de Sherbrooke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRCHUS-Physius Lab</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Mélanie Roch</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>myofascial trigger points,</keyword>
  <keyword>dry needling,</keyword>
  <keyword>stiffness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT04476381
org study id: MON07
nct id: NCT04476381
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The immediate effects (0-30 minutes) of a dry needling intervention on a trigger point on
      their viscoelastic properties (tone, elasticity and stiffness)
Objectives: To investigate the immediate effects of a dry needling puncture on the
      viscoelastic properties (tone, stiffness and elasticity) of a trigger point (TP) located in
      the infraspinatus muscle in participants with non-traumatic chronic shoulder pain.

      Methods: Forty-eight individuals who presented non-traumatic chronic shoulder pain were
      recruited. The presence of a TP in the infraspinatus muscle of the painful side was confirmed
      by an experienced physiotherapist with a palpatory exam according to Travell and Simons
      criteria. The TP was marked and the viscoelastic properties including tone, stiffness and
      elasticity were measured with the MyotonPro device by an evaluator. After the first set of
      measurements (T1), an experienced physiotherapist applied a dry needling puncture to the TP
      with a pistoning technique to obtain a local twitch response (LTR) with an Optimed 40 x 0.30
      mm single use acupuncture needle. The same set of measurements was repeated immediately after
      the dry needling (T2) and 30 minutes later (T3). Repeated measures ANOVA and post-hoc tests
      were used to assess changes in viscoelastic properties over time with a significant level set
      at 0.05.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: One group, one measurement of the viscoelastic properties with the MyotonPro of a single trigger point before the dry needle insertion, one measurement with the MyotonPro right after and 30 minutes later
primary purpose: Treatment
masking: None (Open Label)
measure: Tone in Hertz measured with a myotonometer on the trigger point
time frame: baseline
description: Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point
measure: Tone in Hertz measured with a myotonometer on the trigger point
time frame: immediately after the intervention
description: Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point
measure: Tone in Hertz measured with a myotonometer on the trigger point
time frame: 30 minutes after the intervention
description: Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point
measure: Stiffness in N/m with a myotonometer on the trigger point
time frame: baseline
description: Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point
measure: Stiffness in N/m with a myotonometer on the trigger point
time frame: immediately after the intervention
description: Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point
measure: Stiffness in N/m with a myotonometer on the trigger point
time frame: 30 minutes after the intervention
description: Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point
measure: Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point
time frame: baseline
description: Measurement of the elasticity with the MyotonPro
measure: Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point
time frame: immediately after the intervention
description: Measurement of the elasticity with the MyotonPro
measure: Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point
time frame: 30 minutes after the intervention
description: Measurement of the elasticity with the MyotonPro
arm group label: Dry needling of a trigger point in the infraspinatus muscle
arm group type: Experimental
description: Insertion a a acupuncture type needle into a trigger point in the infraspinatus muscle on the painful side to decrease the stiffness and tone and increase the elasticity
intervention type: Procedure
intervention name: Dry needling
description: Insertion of a Optimed 40mm x 0.30 single use, sterile acupuncture needle into a active trigger point in the infraspinatus muscle
arm group label: Dry needling of a trigger point in the infraspinatus muscle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nathaly Gaudreault, PhD
role: Study Director
affiliation: Université de Sherbrooke
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Mélanie Roch
investigator title: Principal Investigator
mesh term: Shoulder Pain