<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/NCT04454671</url>
  </required_header>
  <id_info>
    <org_study_id>CEIM/HU/2019/26)</org_study_id>
    <nct_id>NCT04454671</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment</brief_title>
  <official_title>Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</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>
      Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12&#xD;
      months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is&#xD;
      an intervention based in an electrical stimulation of a peripheral nerve through a needle&#xD;
      located close to the target nerve by the use of an ultrasound guidance.&#xD;
&#xD;
      Objectives: the primary aim is to determine changes in strength after US-guided PNM or&#xD;
      Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as&#xD;
      well as its effectiveness in changes of muscle function, pain and disability.&#xD;
&#xD;
      Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with&#xD;
      assessment of third parties. 62 adult participants with unilateral mechanical chronic&#xD;
      nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will&#xD;
      randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed&#xD;
      muscle strength, muscle function, pain and disability before, just after, a week and a month&#xD;
      after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain is the third reason for medical consultation in the world. Many treatment&#xD;
      techniques have been proposed. Neuromodulation techniques through the application of an&#xD;
      analgesic electric current using a needle as an electrode, are increasingly used in the&#xD;
      treatment of pain.&#xD;
&#xD;
      In this study, the investigators will compare whether the application of a neuromodulation&#xD;
      technique is more effective than applying the dry needling technique in isolation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 5, 2020</start_date>
  <completion_date type="Anticipated">November 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 15, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Force</measure>
    <time_frame>Change from Baseline force at 1 month</time_frame>
    <description>Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders.&#xD;
Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder Pain</measure>
    <time_frame>Change from Baseline pain at 1 month.</time_frame>
    <description>Pain intensity will be measured using the Visual Analog Scale (VAS) for pain. The VAS is a 100-mm line, oriented horizontally, with one end representing &quot;no pain&quot; and ten the other end representing &quot;worst pain.&quot; Subjects will be asked to rate their current pain with a mark on the scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>Change from Baseline disability at 1 month.</time_frame>
    <description>Disability will be measured by Shoulder Pain and Disability Index (SPADI).The Spanish version of SPADI has high test-retest reliability (ICC 0.89-0.93).The clinically important minimum difference varies between 8 and 13.2. The minimum value is 0 and de maximum value is 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle function</measure>
    <time_frame>Change from Baseline muscle function at 1 month.</time_frame>
    <description>Muscle function will be measured by an ultrasound scanner (VINNO® E35; VINNO ULTRASOUND S.L.U. ©, Barcelona, Spain) with a linear transducer with a frequency range of 6-16MHz (X6-16L, 5cm footprint) will be used. The unit of measurement used will be millimeters. Muscle thickness at rest and contraction will be measured. On the other hand, the percentage of change in thickness will be measured using the equation (Shrinkage thickness - Rest thickness) * 100 / Rest thickness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>ultrasound-guided percutaneous neuromodulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor point. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound-guided dry needling</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound-guided percutaneous neuromodulation (NMPE)</intervention_name>
    <description>It is a technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor site. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve</description>
    <arm_group_label>ultrasound-guided percutaneous neuromodulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound-guided dry needling</intervention_name>
    <description>Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.</description>
    <arm_group_label>Ultrasound-guided dry needling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic mechanical unilateral shoulder pain of non-specific origin of at least 3&#xD;
             months of evolution&#xD;
&#xD;
          -  Weakness in the abduction force and / or external rotation of the shoulder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous shoulder surgery.&#xD;
&#xD;
          -  Previous history of shoulder dislocation&#xD;
&#xD;
          -  Whiplash.&#xD;
&#xD;
          -  Cervical radiculopathy.&#xD;
&#xD;
          -  Total rupture of the rotator cuff.&#xD;
&#xD;
          -  Adhesive capsulitis.&#xD;
&#xD;
          -  Fibromyalgia diagnosis.&#xD;
&#xD;
          -  Diabetes.&#xD;
&#xD;
          -  Needle phobia or some contraindication for dry needling (anticoagulants or psychiatric&#xD;
             disorders).&#xD;
&#xD;
          -  Bilateral shoulder pain.&#xD;
&#xD;
          -  Pregnancy or having received a dry puncture in the shoulder region in the last 6&#xD;
             months&#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>Tomas Gallego-Izquierdo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Alcala University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Pecos-Martín, PhD</last_name>
    <phone>+34 918855142</phone>
    <email>gifyd@uah.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Physiotherapy AND pain</name>
      <address>
        <city>Alcalá De Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Martinez-Merinero, Phd</last_name>
      <phone>683378391</phone>
      <email>info@institutofisioterapiaydolor.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Overall Study Officials</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28807</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laura López-García</last_name>
      <phone>+34 918855142</phone>
      <email>gifyd@uah.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Daniel Pecos Martín</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>Electric Stimulation Therapy</keyword>
  <keyword>Dry Needling</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/NCT04454671
org study id: CEIM/HU/2019/26)
nct id: NCT04454671
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12
      months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is
      an intervention based in an electrical stimulation of a peripheral nerve through a needle
      located close to the target nerve by the use of an ultrasound guidance.

      Objectives: the primary aim is to determine changes in strength after US-guided PNM or
      Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as
      well as its effectiveness in changes of muscle function, pain and disability.

      Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with
      assessment of third parties. 62 adult participants with unilateral mechanical chronic
      nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will
      randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed
      muscle strength, muscle function, pain and disability before, just after, a week and a month
      after the intervention.
Shoulder pain is the third reason for medical consultation in the world. Many treatment
      techniques have been proposed. Neuromodulation techniques through the application of an
      analgesic electric current using a needle as an electrode, are increasingly used in the
      treatment of pain.

      In this study, the investigators will compare whether the application of a neuromodulation
      technique is more effective than applying the dry needling technique in isolation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Muscle Force
time frame: Change from Baseline force at 1 month
description: Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders.
Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55
measure: Shoulder Pain
time frame: Change from Baseline pain at 1 month.
description: Pain intensity will be measured using the Visual Analog Scale (VAS) for pain. The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
measure: Disability
time frame: Change from Baseline disability at 1 month.
description: Disability will be measured by Shoulder Pain and Disability Index (SPADI).The Spanish version of SPADI has high test-retest reliability (ICC 0.89-0.93).The clinically important minimum difference varies between 8 and 13.2. The minimum value is 0 and de maximum value is 100
measure: Muscle function
time frame: Change from Baseline muscle function at 1 month.
description: Muscle function will be measured by an ultrasound scanner (VINNO® E35; VINNO ULTRASOUND S.L.U. ©, Barcelona, Spain) with a linear transducer with a frequency range of 6-16MHz (X6-16L, 5cm footprint) will be used. The unit of measurement used will be millimeters. Muscle thickness at rest and contraction will be measured. On the other hand, the percentage of change in thickness will be measured using the equation (Shrinkage thickness - Rest thickness) * 100 / Rest thickness.
arm group label: ultrasound-guided percutaneous neuromodulation
arm group type: Experimental
description: Technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor point. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve
arm group label: Ultrasound-guided dry needling
arm group type: Placebo Comparator
description: Dry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve.
intervention type: Other
intervention name: Ultrasound-guided percutaneous neuromodulation (NMPE)
description: It is a technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor site. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve
arm group label: ultrasound-guided percutaneous neuromodulation
intervention type: Other
intervention name: Ultrasound-guided dry needling
description: Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.
arm group label: Ultrasound-guided dry needling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tomas Gallego-Izquierdo, PhD
role: Study Chair
affiliation: Alcala University
last name: Daniel Pecos-Martín, PhD
phone: +34 918855142
email: gifyd@uah.es
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Prof. Dr. Daniel Pecos Martín
investigator title: Clinical professor
mesh term: Shoulder Pain