<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/NCT02970890</url>
  </required_header>
  <id_info>
    <org_study_id>066490</org_study_id>
    <nct_id>NCT02970890</nct_id>
  </id_info>
  <brief_title>Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty</brief_title>
  <official_title>Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adriane Aver Vanin</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>
      Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear,&#xD;
      causes progressive joint deformity and loss of function leading to the indication of total&#xD;
      hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and&#xD;
      induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue&#xD;
      repair by modulating the inflammatory process and promoting pain relief. It can therefore be&#xD;
      part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain&#xD;
      of patients who underwent total hip arthroplasty. The study consisted of eighteen patients&#xD;
      who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours&#xD;
      after surgery. We divided the patients into two groups (n=9 each) placebo and effective&#xD;
      phototherapy. The patients were evaluated before and after phototherapy with 9 diodes,&#xD;
      applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J&#xD;
      total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the&#xD;
      cytokines TNF-α, IL-6 and IL-8.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Pain (VAS)</measure>
    <time_frame>Change from baseline in VAS to immediately after phototherapy</time_frame>
    <description>A visual analogue scale (VAS) of 100 mm was used for the self-rating of the patients pain intensity, with assistance of a blinded researcher. Pain assessments were performed at baseline, immediately after phototherapy irradiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Cytokines levels (ELISA immunoenzymatic assay)</measure>
    <time_frame>Change from baseline in Cytokines levels to immediately after phototherapy</time_frame>
    <description>Cytokine levels (IL-6, IL-8 and TNF-α) in blood samples collected from patients before and after irradiation of phototherapy were evaluated using the Duo Set kit (BD Biosciences) according to the manufacturer's instructions.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Arthroplasty, Replacement, Hip</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects received placebo therapy. The placebo Portable Pain Away™ device was identical to the active device, displayed the same settings and emitted the same sound regardless of the comparator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBMT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects received active photobiomodulation therapy (PBMT). The active Portable Pain Away™ device was identical to the placebo device, displayed the same settings and emitted the same sound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable Pain Away™</intervention_name>
    <description>Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy</description>
    <arm_group_label>PBMT group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Photobiomodulation therapy (PBMT)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Men and women with clinical diagnosis of OA based on radiological images in the&#xD;
        anteroposterior and profile according to Demur classification.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Men and women with other clinical diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Beneficência Nossa Senhora do Pari</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>03031-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Adriane Aver Vanin</investigator_full_name>
    <investigator_title>MsC, PhD candidate</investigator_title>
  </responsible_party>
  <keyword>Total Hip Arthroplasty (THA)</keyword>
  <keyword>Phototherapy</keyword>
  <keyword>Low-level laser therapy</keyword>
  <keyword>Light-emitting diodes</keyword>
  <!-- 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/NCT02970890
org study id: 066490
nct id: NCT02970890
lead sponsor: 
has dmc: Yes
Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear,
      causes progressive joint deformity and loss of function leading to the indication of total
      hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and
      induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue
      repair by modulating the inflammatory process and promoting pain relief. It can therefore be
      part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain
      of patients who underwent total hip arthroplasty. The study consisted of eighteen patients
      who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours
      after surgery. We divided the patients into two groups (n=9 each) placebo and effective
      phototherapy. The patients were evaluated before and after phototherapy with 9 diodes,
      applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J
      total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the
      cytokines TNF-α, IL-6 and IL-8.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Evaluation of Pain (VAS)
time frame: Change from baseline in VAS to immediately after phototherapy
description: A visual analogue scale (VAS) of 100 mm was used for the self-rating of the patients pain intensity, with assistance of a blinded researcher. Pain assessments were performed at baseline, immediately after phototherapy irradiation.
measure: Evaluation of Cytokines levels (ELISA immunoenzymatic assay)
time frame: Change from baseline in Cytokines levels to immediately after phototherapy
description: Cytokine levels (IL-6, IL-8 and TNF-α) in blood samples collected from patients before and after irradiation of phototherapy were evaluated using the Duo Set kit (BD Biosciences) according to the manufacturer's instructions.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Subjects received placebo therapy. The placebo Portable Pain Away™ device was identical to the active device, displayed the same settings and emitted the same sound regardless of the comparator.
arm group label: PBMT group
arm group type: Active Comparator
description: Subjects received active photobiomodulation therapy (PBMT). The active Portable Pain Away™ device was identical to the placebo device, displayed the same settings and emitted the same sound.
intervention type: Device
intervention name: Portable Pain Away™
description: Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy
arm group label: PBMT group
arm group label: Placebo group
other name: Photobiomodulation therapy (PBMT)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Adriane Aver Vanin
investigator title: MsC, PhD candidate