<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/NCT04457466</url>
  </required_header>
  <id_info>
    <org_study_id>10042017</org_study_id>
    <nct_id>NCT04457466</nct_id>
  </id_info>
  <brief_title>Assessment of the Effects of Extensive Somatosensory Training on Pain Processing</brief_title>
  <official_title>Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish National Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University</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>
      Persistent pain may lead to several alterations in the brain activity and sensory perception&#xD;
      (i.e. pain). Around 80% of professional musicians experience prolonged episodes of&#xD;
      musculoskeletal pain throughout their careers, a percentage that is four times higher than in&#xD;
      the general population. With this background, the intended experiment aims at understanding&#xD;
      the role of several biological factors associated to sensorimotor training that can lead to&#xD;
      alteration of the brain activity and, consequently, pain processing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Covid-19&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Pain rating</measure>
    <time_frame>Changes from baseline measured at day 3 and day 8</time_frame>
    <description>Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortical Sensory Evoked Potentials</measure>
    <time_frame>Changes from baseline measured at day 3 and day 8</time_frame>
    <description>Electrical stimulation will be elicited to record sensory evoked potentials using electroencephalography (EEG)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor Evoked Potentials</measure>
    <time_frame>Changes from baseline measured at day 3 and day 8</time_frame>
    <description>Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain connectivity</measure>
    <time_frame>Changes from baseline measured at day 3 and day 8</time_frame>
    <description>Continuous electroencephalography recording will be used to explore connectivity between brain areas</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaires</measure>
    <time_frame>Changes from baseline measured at day 3 and day 8</time_frame>
    <description>Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain thresholds</measure>
    <time_frame>Changes from baseline measured at day 3 and day 8</time_frame>
    <description>Pressure applied to the surface of the skin using a handheld algometer</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Healthy musicians</arm_group_label>
    <description>Men and women aged 18-60, who must be enrolled in a music conservatory performance program or be professionally active, and must speak and understand English.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy non-musicians</arm_group_label>
    <description>Men and women aged 18-60, must speak and understand English and not have any kind of musical training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Musicians with chronic pain</arm_group_label>
    <description>Men and women aged 18-60 with chronic and idiopathic musculoskeletal upper limb and/or neck pain lasting more than 6 months. They must be enrolled in a music conservatory performance program or be professionally active and must speak and understand English.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-musicians with chronic pain</arm_group_label>
    <description>Men and women aged 18-60 with chronic and idiopathic musculoskeletal upper limb and/or neck pain lasting more than 6 months. They must not have any kind of musical training and must speak and understand English.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nerve Growth Factor</intervention_name>
    <description>Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.</description>
    <arm_group_label>Healthy musicians</arm_group_label>
    <arm_group_label>Healthy non-musicians</arm_group_label>
    <arm_group_label>Musicians with chronic pain</arm_group_label>
    <arm_group_label>Non-musicians with chronic pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy men and women Speak and understand English.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy men and women Speak and understand English.&#xD;
&#xD;
        General exclusion criteria are:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Drug addiction defined as the use of cannabis, opioids or other drugs&#xD;
&#xD;
          -  Previous neurologic or mental illnesses&#xD;
&#xD;
          -  Presence of a history of trauma or neurologic entrapment syndromes to the arm regions.&#xD;
&#xD;
          -  Lack of ability to cooperate&#xD;
&#xD;
          -  Frequent computer gamer ( &gt; 9 hours/week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aalborg University</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Anna M. Zamorano</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04457466
org study id: 10042017
nct id: NCT04457466
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Persistent pain may lead to several alterations in the brain activity and sensory perception
      (i.e. pain). Around 80% of professional musicians experience prolonged episodes of
      musculoskeletal pain throughout their careers, a percentage that is four times higher than in
      the general population. With this background, the intended experiment aims at understanding
      the role of several biological factors associated to sensorimotor training that can lead to
      alteration of the brain activity and, consequently, pain processing.
observational model: Cohort
time perspective: Prospective
measure: Pain rating
time frame: Changes from baseline measured at day 3 and day 8
description: Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
measure: Cortical Sensory Evoked Potentials
time frame: Changes from baseline measured at day 3 and day 8
description: Electrical stimulation will be elicited to record sensory evoked potentials using electroencephalography (EEG)
measure: Motor Evoked Potentials
time frame: Changes from baseline measured at day 3 and day 8
description: Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs)
measure: Brain connectivity
time frame: Changes from baseline measured at day 3 and day 8
description: Continuous electroencephalography recording will be used to explore connectivity between brain areas
measure: Questionnaires
time frame: Changes from baseline measured at day 3 and day 8
description: Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance)
measure: Pressure pain thresholds
time frame: Changes from baseline measured at day 3 and day 8
description: Pressure applied to the surface of the skin using a handheld algometer
arm group label: Healthy musicians
description: Men and women aged 18-60, who must be enrolled in a music conservatory performance program or be professionally active, and must speak and understand English.
arm group label: Healthy non-musicians
description: Men and women aged 18-60, must speak and understand English and not have any kind of musical training.
arm group label: Musicians with chronic pain
description: Men and women aged 18-60 with chronic and idiopathic musculoskeletal upper limb and/or neck pain lasting more than 6 months. They must be enrolled in a music conservatory performance program or be professionally active and must speak and understand English.
arm group label: Non-musicians with chronic pain
description: Men and women aged 18-60 with chronic and idiopathic musculoskeletal upper limb and/or neck pain lasting more than 6 months. They must not have any kind of musical training and must speak and understand English.
intervention type: Drug
intervention name: Nerve Growth Factor
description: Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.
arm group label: Healthy musicians
arm group label: Healthy non-musicians
arm group label: Musicians with chronic pain
arm group label: Non-musicians with chronic pain
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Anna M. Zamorano
investigator title: Principal Investigator
mesh term: Musculoskeletal Pain
mesh term: Mitogens
sharing ipd: Undecided