<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/NCT04489784</url>
  </required_header>
  <id_info>
    <org_study_id>Ballet</org_study_id>
    <nct_id>NCT04489784</nct_id>
  </id_info>
  <brief_title>Infrared Laser and Classical Ballerinas' Feet</brief_title>
  <official_title>Effects of the Infrared Laser on Classical Ballerinas' Feet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      Overuse injuries and painful symptoms in athletes and dancers (especially classical&#xD;
      ballerinas) may lead to reduced functional performance. However, laser application may reduce&#xD;
      pain and increase physical conditioning. The aim of the current study was to evaluate the&#xD;
      immediate and long-term effects of infrared laser on classical ballerinas' feet. The&#xD;
      hypothesis investigators was that the infrared laser would be able to reduce pain perception&#xD;
      and enhance functional performance in ballerinas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High risk of injuries and painful symptoms in athletes and dancers (especially classical&#xD;
      ballerinas) may lead to reduced functional performance. The use of photobiomodulation may&#xD;
      improve functional performance in ballerinas that are affected by foot pain. An aluminum&#xD;
      gallium arsenide (AlGaAs) diode laser device was uded. Infrared laser (808 nm) was applied on&#xD;
      ballerina's feet twice a week during three months. Thermography, algometry and unipodal&#xD;
      static standing balance test were performed. There were pain relief and improvement of&#xD;
      functional performance in ballerinas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 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>To evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of pain for feet by algometry</measure>
    <time_frame>3 months</time_frame>
    <description>Pressure pain thresholds (PPT) were assessed with an electronic algometer. The pressure was applied and the ballerinas were instructed to ask to say &quot;stop&quot; when the sensation changed from pressure to pain. Three PPT measurements were performed to obtain an average.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of pain for feet by the visual analogue pain intensity scale</measure>
    <time_frame>3 months</time_frame>
    <description>A continuous scale comprised of a horizontal line with 10 centimeters in length was used. All ballerinas were instructed to make a mark with a pen at any point on the line between 2 verbal descriptors, one for each symptom extreme [&quot;No pain&quot; (score=0) and &quot;as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score=10)].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance Test</measure>
    <time_frame>3 months</time_frame>
    <description>Static Standing Balance Test was performed. Ballerinas were instructed to stand on one foot to a maximum of one minute. The time was measured in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thermal Analysis</measure>
    <time_frame>3 months</time_frame>
    <description>Cutaneous temperatures of ballerina's feet were analyzed by thermography.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser treatment on ballerina's feet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Infrared Laser</intervention_name>
    <description>An aluminum gallium arsenide (AlGaAs) diode laser device (Twin laser, MMOptics, São Carlos, SP, Brazil) was used. The irradiation parameters were as follows: infrared laser (808 nm wavelength) with a spot area of 0.04 cm2, and an average optical power of 100 mW operated in a continuous mode during 1 minute per point, leading to an irradiance of 2,500 mW/cm2, energy of 6 J and fluence of 125 J/cm2 per point. The laser was applied on ballerina's feet twice a week during three months.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Female adults who perform classical ballet training and feel pain in their foot&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - The occurrence of injuries in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fernanda Rossi Paolillo</name>
      <address>
        <city>São Carlos</city>
        <state>São Paulo</state>
        <zip>13569600</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.</citation>
    <PMID>19731300</PMID>
  </reference>
  <reference>
    <citation>Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, Bagnato VS. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018 May;38(5):785-793. doi: 10.1007/s00296-018-4000-x. Epub 2018 Feb 26.</citation>
    <PMID>29480363</PMID>
  </reference>
  <reference>
    <citation>Adabbo M, Paolillo FR, Bossini PS, Rodrigues NC, Bagnato VS, Parizotto NA. Effects of Low-Level Laser Therapy Applied Before Treadmill Training on Recovery of Injured Skeletal Muscle in Wistar Rats. Photomed Laser Surg. 2016 May;34(5):187-93. doi: 10.1089/pho.2015.4031. Epub 2016 Apr 8.</citation>
    <PMID>27058781</PMID>
  </reference>
  <reference>
    <citation>Shah S. Determining a young dancer's readiness for dancing on pointe. Curr Sports Med Rep. 2009 Nov-Dec;8(6):295-9. doi: 10.1249/JSR.0b013e3181c1ddf1.</citation>
    <PMID>19904068</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Fernanda Rossi Paolillo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Feet</keyword>
  <keyword>Ballerinas</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan</ipd_description>
  </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/NCT04489784
org study id: Ballet
nct id: NCT04489784
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Overuse injuries and painful symptoms in athletes and dancers (especially classical
      ballerinas) may lead to reduced functional performance. However, laser application may reduce
      pain and increase physical conditioning. The aim of the current study was to evaluate the
      immediate and long-term effects of infrared laser on classical ballerinas' feet. The
      hypothesis investigators was that the infrared laser would be able to reduce pain perception
      and enhance functional performance in ballerinas.
High risk of injuries and painful symptoms in athletes and dancers (especially classical
      ballerinas) may lead to reduced functional performance. The use of photobiomodulation may
      improve functional performance in ballerinas that are affected by foot pain. An aluminum
      gallium arsenide (AlGaAs) diode laser device was uded. Infrared laser (808 nm) was applied on
      ballerina's feet twice a week during three months. Thermography, algometry and unipodal
      static standing balance test were performed. There were pain relief and improvement of
      functional performance in ballerinas.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: To evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet.
primary purpose: Treatment
masking: None (Open Label)
measure: Analysis of pain for feet by algometry
time frame: 3 months
description: Pressure pain thresholds (PPT) were assessed with an electronic algometer. The pressure was applied and the ballerinas were instructed to ask to say "stop" when the sensation changed from pressure to pain. Three PPT measurements were performed to obtain an average.
measure: Analysis of pain for feet by the visual analogue pain intensity scale
time frame: 3 months
description: A continuous scale comprised of a horizontal line with 10 centimeters in length was used. All ballerinas were instructed to make a mark with a pen at any point on the line between 2 verbal descriptors, one for each symptom extreme ["No pain" (score=0) and "as bad as it could be" or "worst imaginable pain" (score=10)].
measure: Balance Test
time frame: 3 months
description: Static Standing Balance Test was performed. Ballerinas were instructed to stand on one foot to a maximum of one minute. The time was measured in seconds.
measure: Thermal Analysis
time frame: 3 months
description: Cutaneous temperatures of ballerina's feet were analyzed by thermography.
arm group label: Treatment
arm group type: Experimental
description: Laser treatment on ballerina's feet.
intervention type: Device
intervention name: Infrared Laser
description: An aluminum gallium arsenide (AlGaAs) diode laser device (Twin laser, MMOptics, São Carlos, SP, Brazil) was used. The irradiation parameters were as follows: infrared laser (808 nm wavelength) with a spot area of 0.04 cm2, and an average optical power of 100 mW operated in a continuous mode during 1 minute per point, leading to an irradiance of 2,500 mW/cm2, energy of 6 J and fluence of 125 J/cm2 per point. The laser was applied on ballerina's feet twice a week during three months.
arm group label: Treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Brazil
citation: Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
PMID: 19731300
citation: Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, Bagnato VS. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018 May;38(5):785-793. doi: 10.1007/s00296-018-4000-x. Epub 2018 Feb 26.
PMID: 29480363
citation: Adabbo M, Paolillo FR, Bossini PS, Rodrigues NC, Bagnato VS, Parizotto NA. Effects of Low-Level Laser Therapy Applied Before Treadmill Training on Recovery of Injured Skeletal Muscle in Wistar Rats. Photomed Laser Surg. 2016 May;34(5):187-93. doi: 10.1089/pho.2015.4031. Epub 2016 Apr 8.
PMID: 27058781
citation: Shah S. Determining a young dancer's readiness for dancing on pointe. Curr Sports Med Rep. 2009 Nov-Dec;8(6):295-9. doi: 10.1249/JSR.0b013e3181c1ddf1.
PMID: 19904068
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Fernanda Rossi Paolillo
investigator title: Professor
sharing ipd: No
ipd description: No plan