<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/NCT03031223</url>
  </required_header>
  <id_info>
    <org_study_id>Uni9</org_study_id>
    <nct_id>NCT03031223</nct_id>
  </id_info>
  <brief_title>Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries</brief_title>
  <official_title>Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries - Protocol for a Randomized, Controlled, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal cord injuries have become increasingly frequent due mainly to the increase in urban&#xD;
      violence. The growing number of automobile collisions and violence-related events merits&#xD;
      particular attention, as such occurrences can lead to death or disability stemming from a&#xD;
      spinal injury. The severity of the consequences depends on the location affected and degree&#xD;
      of destruction of afferent and efferent spinal cord pathways, with higher, more extensive&#xD;
      injuries leading to less physical fitness and functional independence. Unfortunately, injured&#xD;
      neurons of the central nervous system are unable to regenerate following a spinal injury and&#xD;
      spinal cord regeneration is therefore a major challenge to researchers in the fields of&#xD;
      neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system&#xD;
      is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss&#xD;
      and promote, even if partially, the remodeling of remaining synaptic connections, leading to&#xD;
      new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for&#xD;
      the stimulation of the repair process in the central nervous system. It is plausible that&#xD;
      this type of therapy can offer the same benefits previously established in other types of&#xD;
      tissues, the stimulation of bone formation, neovascularization and the regeneration of&#xD;
      peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment&#xD;
      of spinal cord injuries and have demonstrated that laser therapy administered simultaneously&#xD;
      to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the&#xD;
      regeneration process of the injured peripheral nerve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General objective - Evaluate the effect of LLLT on the sensory-motor response in individuals&#xD;
      having suffered a spinal cord injury.&#xD;
&#xD;
      Specific objectives - Investigate the maintenance of the possible sensory-motor response&#xD;
      through electromyographic analyses conducted before LLLT and as well as one, 15, 30, 45 and&#xD;
      60 days after the intervention; evaluate functional independence and quality of life in&#xD;
      individuals having suffered a spinal cord injury.&#xD;
&#xD;
      Trial design - A randomized, controlled, clinical trial is proposed. displays the flowchart&#xD;
      of the development of the study. The trial will be conducted in compliance with the norms&#xD;
      governing research involving human subjects and will be submitted for the approval of the&#xD;
      Institutional Review Board of University Nove de Julho, São Paulo, Brazil. All participants&#xD;
      or their legal guardians will receive clarifications regarding the objectives and procedures&#xD;
      of the study and those agreeing to participate will sign a statement of informed consent.&#xD;
&#xD;
      Methods: Participants, interventions and outcomes&#xD;
&#xD;
      Study setting - Physical Therapy Clinics of University Nove de Julho, São Paulo, Brazil&#xD;
      Exclusion criteria: complete spinal cord injury, cognitive impairment.&#xD;
&#xD;
      Interventions - The volunteers will be randomly allocated to a control group or treatment&#xD;
      group. Evaluations will be conducted before and after the intervention using electromyography&#xD;
      of the myotome corresponding to the injured spinal nerve root. The treatment group will&#xD;
      receive LLLT following the protocol outlined below:&#xD;
&#xD;
      LLLT protocol - Based on Byrnes et al. and Holanda et al., radiance will be administered to&#xD;
      the injury site transcutaneously at a wavelength of 808 nm using a Twin Flex Evolution diode&#xD;
      laser (MMO Equipamento Opto-Eletronicos, Brazil). Twelve sessions will be held (three per&#xD;
      week over four weeks). The dose administered to the surface of the skin will be 983 J/cm2 per&#xD;
      session, with a treatment area of 4.72 W/cm² and total radiant energy of 25 J.&#xD;
&#xD;
      According to the literature, this dose is capable of enhancing functional recovery following&#xD;
      an injury.&#xD;
&#xD;
      Recruitment Individuals will be recruited from the physical therapy clinics of University&#xD;
      Nove de Julho (São Paulo, Brazil) as well as spinal injury associations, if necessary.&#xD;
&#xD;
      Methods: Assignment of interventions (for controlled trials)&#xD;
&#xD;
      Sequence generation The individuals will be allocated to the different groups based on&#xD;
      numbers randomly generated by a computer program.&#xD;
&#xD;
      Allocation concealment mechanism Allocation will be concealed with the use of sealed opaque&#xD;
      envelopes. Each envelope will be numbered on the outside and will contain the name of a&#xD;
      participant on the inside. The envelopes will be randomly selected using a computer program,&#xD;
      with the formation of the control group first, followed by the treatment group.&#xD;
&#xD;
      Implementation The volunteers will be enrolled in the research project of MSc. Fernanda&#xD;
      Cordeiro da Silva and the envelopes will be prepared by researcher Paulo Roberto da Costa&#xD;
      Palácio. Dr. Sandra Kalil Bussadori will head the project and will run the computer program&#xD;
      for the random allocation of the volunteers to the different groups.&#xD;
&#xD;
      Blinding - There will be no blinding.&#xD;
&#xD;
      Methods: Data collection, management and analysis The data will be tabulated and treated&#xD;
      using the SPSS 20.0 program for WindowsTM. The data will be submitted to descriptive&#xD;
      statistical analysis. The chi-square test and Fisher's exact test will be used to establish&#xD;
      the associations of the categorical variables. The Student's t-test will be used for the&#xD;
      comparison of mean electromyographic signals. Pearson's correlation coefficients will be&#xD;
      calculated for the analysis of the correlation of the continuous variables. The level of&#xD;
      significance will be 95% (p &lt; 0.05).&#xD;
&#xD;
      Ethics and dissemination&#xD;
&#xD;
      Research ethics approval - The trial will be conducted in compliance with the norms governing&#xD;
      research involving human subjects and will be submitted for the approval of the Institutional&#xD;
      Review Board of University Nove de Julho, São Paulo, Brazil. All participants or their legal&#xD;
      guardians will receive clarifications regarding the objectives and procedures of the study&#xD;
      and those agreeing to participate will sign a statement of informed consent.&#xD;
&#xD;
      Consent or assent - Researchers MSc. Fernanda Cordeiro da Silva and Paulo Roberto da Costa&#xD;
      Palácio will present and explain the statement of informed consent to each volunteer. All&#xD;
      participants will be informed with regard to the voluntary nature of participation and the&#xD;
      possibility of withdrawing from the study at any time with no negative consequences.&#xD;
&#xD;
      Confidentiality - All data collected from the volunteers during the evaluations and&#xD;
      treatments will be stored a hard drive to ensure confidentiality.&#xD;
&#xD;
      Declaration of interests - The authors declare no conflicts of interest. Access to data -&#xD;
      Only the researchers directly involved in the study will have access to the data.&#xD;
&#xD;
      Ancillary and post-trial care - At the end of the study, all volunteers allocated to the&#xD;
      control group will receive LLLT with the same protocol administered to the treatment group to&#xD;
      avoid any inequality regarding treatment among the individuals.&#xD;
&#xD;
      Dissemination policy - The findings will be published in scientific journals and presented at&#xD;
      conferences on the application of laser therapy and treatment for individuals with spinal&#xD;
      injuries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyography</measure>
    <time_frame>15 days after the intervention</time_frame>
    <description>Pre and post-laser electromyography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>low-level laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment group will receive LLLT following the protocol outlined below:&#xD;
LLLT protocol - radiance will be administered to the injury site transcutaneously at a wavelength of 808 nm using a Twin Flex Evolution diode laser (MMO Equipamento Opto-Eletronicos, Brazil). Twelve sessions will be held (three per week over four weeks). The dose administered to the surface of the skin will be 983 J/cm2 per session, with a treatment area of 4.72 W/cm² and total radiant energy of 25 J. According to the literature, this dose is capable of enhancing functional recovery following an injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>laser therapy is applied at low intensity without emitting radiation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>low-level laser therapy</intervention_name>
    <description>low-level laser therapy</description>
    <arm_group_label>low-level laser therapy</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  partial spinal injury;&#xD;
&#xD;
          -  patients with tetraplegia or paraplegia;&#xD;
&#xD;
          -  injury between C3 and L5;&#xD;
&#xD;
          -  up to one year elapsed since injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complete spinal cord injury;&#xD;
&#xD;
          -  cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernanda C. da Silva, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nove de Julho</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fernanda C. da Silva, master</last_name>
    <phone>005511968249579</phone>
    <email>fernandacordeiro@uninove.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sandra K. Bussadori, Doctor</last_name>
    <email>sandra.skb@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidade Nove de Julho</name>
      <address>
        <city>São Paulo</city>
        <state>São Paulo/SP</state>
        <zip>01.504-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernanda C. da Silva, master</last_name>
    </contact>
    <investigator>
      <last_name>Sandra K. Bussadori, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paulo Roberto C. Palácio</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fernanda C. da Silva, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Fernanda Cordeiro da Silva</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Spinal cord injuries</keyword>
  <keyword>low-level laser therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Spinal Injuries</mesh_term>
  </condition_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/NCT03031223
org study id: Uni9
nct id: NCT03031223
lead sponsor: 
has dmc: Yes
Spinal cord injuries have become increasingly frequent due mainly to the increase in urban
      violence. The growing number of automobile collisions and violence-related events merits
      particular attention, as such occurrences can lead to death or disability stemming from a
      spinal injury. The severity of the consequences depends on the location affected and degree
      of destruction of afferent and efferent spinal cord pathways, with higher, more extensive
      injuries leading to less physical fitness and functional independence. Unfortunately, injured
      neurons of the central nervous system are unable to regenerate following a spinal injury and
      spinal cord regeneration is therefore a major challenge to researchers in the fields of
      neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system
      is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss
      and promote, even if partially, the remodeling of remaining synaptic connections, leading to
      new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for
      the stimulation of the repair process in the central nervous system. It is plausible that
      this type of therapy can offer the same benefits previously established in other types of
      tissues, the stimulation of bone formation, neovascularization and the regeneration of
      peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment
      of spinal cord injuries and have demonstrated that laser therapy administered simultaneously
      to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the
      regeneration process of the injured peripheral nerve.
General objective - Evaluate the effect of LLLT on the sensory-motor response in individuals
      having suffered a spinal cord injury.

      Specific objectives - Investigate the maintenance of the possible sensory-motor response
      through electromyographic analyses conducted before LLLT and as well as one, 15, 30, 45 and
      60 days after the intervention; evaluate functional independence and quality of life in
      individuals having suffered a spinal cord injury.

      Trial design - A randomized, controlled, clinical trial is proposed. displays the flowchart
      of the development of the study. The trial will be conducted in compliance with the norms
      governing research involving human subjects and will be submitted for the approval of the
      Institutional Review Board of University Nove de Julho, São Paulo, Brazil. All participants
      or their legal guardians will receive clarifications regarding the objectives and procedures
      of the study and those agreeing to participate will sign a statement of informed consent.

      Methods: Participants, interventions and outcomes

      Study setting - Physical Therapy Clinics of University Nove de Julho, São Paulo, Brazil
      Exclusion criteria: complete spinal cord injury, cognitive impairment.

      Interventions - The volunteers will be randomly allocated to a control group or treatment
      group. Evaluations will be conducted before and after the intervention using electromyography
      of the myotome corresponding to the injured spinal nerve root. The treatment group will
      receive LLLT following the protocol outlined below:

      LLLT protocol - Based on Byrnes et al. and Holanda et al., radiance will be administered to
      the injury site transcutaneously at a wavelength of 808 nm using a Twin Flex Evolution diode
      laser (MMO Equipamento Opto-Eletronicos, Brazil). Twelve sessions will be held (three per
      week over four weeks). The dose administered to the surface of the skin will be 983 J/cm2 per
      session, with a treatment area of 4.72 W/cm² and total radiant energy of 25 J.

      According to the literature, this dose is capable of enhancing functional recovery following
      an injury.

      Recruitment Individuals will be recruited from the physical therapy clinics of University
      Nove de Julho (São Paulo, Brazil) as well as spinal injury associations, if necessary.

      Methods: Assignment of interventions (for controlled trials)

      Sequence generation The individuals will be allocated to the different groups based on
      numbers randomly generated by a computer program.

      Allocation concealment mechanism Allocation will be concealed with the use of sealed opaque
      envelopes. Each envelope will be numbered on the outside and will contain the name of a
      participant on the inside. The envelopes will be randomly selected using a computer program,
      with the formation of the control group first, followed by the treatment group.

      Implementation The volunteers will be enrolled in the research project of MSc. Fernanda
      Cordeiro da Silva and the envelopes will be prepared by researcher Paulo Roberto da Costa
      Palácio. Dr. Sandra Kalil Bussadori will head the project and will run the computer program
      for the random allocation of the volunteers to the different groups.

      Blinding - There will be no blinding.

      Methods: Data collection, management and analysis The data will be tabulated and treated
      using the SPSS 20.0 program for WindowsTM. The data will be submitted to descriptive
      statistical analysis. The chi-square test and Fisher's exact test will be used to establish
      the associations of the categorical variables. The Student's t-test will be used for the
      comparison of mean electromyographic signals. Pearson's correlation coefficients will be
      calculated for the analysis of the correlation of the continuous variables. The level of
      significance will be 95% (p < 0.05).

      Ethics and dissemination

      Research ethics approval - The trial will be conducted in compliance with the norms governing
      research involving human subjects and will be submitted for the approval of the Institutional
      Review Board of University Nove de Julho, São Paulo, Brazil. All participants or their legal
      guardians will receive clarifications regarding the objectives and procedures of the study
      and those agreeing to participate will sign a statement of informed consent.

      Consent or assent - Researchers MSc. Fernanda Cordeiro da Silva and Paulo Roberto da Costa
      Palácio will present and explain the statement of informed consent to each volunteer. All
      participants will be informed with regard to the voluntary nature of participation and the
      possibility of withdrawing from the study at any time with no negative consequences.

      Confidentiality - All data collected from the volunteers during the evaluations and
      treatments will be stored a hard drive to ensure confidentiality.

      Declaration of interests - The authors declare no conflicts of interest. Access to data -
      Only the researchers directly involved in the study will have access to the data.

      Ancillary and post-trial care - At the end of the study, all volunteers allocated to the
      control group will receive LLLT with the same protocol administered to the treatment group to
      avoid any inequality regarding treatment among the individuals.

      Dissemination policy - The findings will be published in scientific journals and presented at
      conferences on the application of laser therapy and treatment for individuals with spinal
      injuries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Electromyography
time frame: 15 days after the intervention
description: Pre and post-laser electromyography
arm group label: low-level laser therapy
arm group type: Experimental
description: The treatment group will receive LLLT following the protocol outlined below:
LLLT protocol - radiance will be administered to the injury site transcutaneously at a wavelength of 808 nm using a Twin Flex Evolution diode laser (MMO Equipamento Opto-Eletronicos, Brazil). Twelve sessions will be held (three per week over four weeks). The dose administered to the surface of the skin will be 983 J/cm2 per session, with a treatment area of 4.72 W/cm² and total radiant energy of 25 J. According to the literature, this dose is capable of enhancing functional recovery following an injury.
arm group label: placebo
arm group type: Placebo Comparator
description: laser therapy is applied at low intensity without emitting radiation.
intervention type: Radiation
intervention name: low-level laser therapy
description: low-level laser therapy
arm group label: low-level laser therapy
arm group label: placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Fernanda C. da Silva, master
role: Principal Investigator
affiliation: University of Nove de Julho
last name: Fernanda C. da Silva, master
phone: 005511968249579
email: fernandacordeiro@uninove.br
last name: Sandra K. Bussadori, Doctor
email: sandra.skb@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Fernanda Cordeiro da Silva
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Spinal Injuries
sharing ipd: Undecided