<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/NCT03777072</url>
  </required_header>
  <id_info>
    <org_study_id>ARP1</org_study_id>
    <nct_id>NCT03777072</nct_id>
  </id_info>
  <brief_title>New App for Monitoring Postoperative Pain in Total Ankle Replacement</brief_title>
  <official_title>Evaluation of a Novel Web-based Application for Monitoring Postoperative Pain in Patients Underwent Total Ankle Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Galeazzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Galeazzi</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>
      The study evaluates a novel web-based application for monitoring the postoperative pain in&#xD;
      patients undergoing total ankle replacement, from preoperative condition to 30 days&#xD;
      follow-up. The indexes provided by the app in terms of percentages of pain areas are compared&#xD;
      with that obtained with traditional visual analogue scale. Moreover, the relation between the&#xD;
      percentage of pain area and the presence of side effects of the intervention are compared as&#xD;
      well.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      The management of postoperative pain in patients undergoing total ankle replacement is&#xD;
      routinely based on one of the two following drugs: tapentadol and oxycodone/naloxone (Nett,&#xD;
      2010). The drugs are used with similar frequencies. Indeed, previous studies compared the two&#xD;
      drugs in terms of efficacy in reducing postoperative pain and frequency of side effects, in&#xD;
      the field of orthopaedic and trauma surgery (Haeseler, 2017, Hartrick, 2009). The studies&#xD;
      demonstrated that there are no substantial differences.&#xD;
&#xD;
      With regard to pain monitoring, the gold standard is the visual-analogue scale (VAS), which&#xD;
      allows the patient to indicate the pain level as a score ranging from 0 to 10 (from minimum&#xD;
      to maximum) (Campbell, 1990). Recently, a pain monitoring web-based application has been&#xD;
      developed and distributed: 'NavigatePain' (NavigatePain, Aglance Solutions, Denmark). The app&#xD;
      can be used in a simple and intuitive manner by PC, smartphone or tablet devices (Boudreau,&#xD;
      2016; Matthews, 2018). Moreover, physicians can easily schedule postoperative self-monitoring&#xD;
      sessions for the patients (exploiting automatic notification messages sent by e-mail). The&#xD;
      app allows the user to draw the pain areas in the frontal, posterior and lateral body planes,&#xD;
      providing an index that quantifies the percentage of pain area with respect to the total body&#xD;
      area in the considered plane. VAS score and notes reporting side effects can be reported as&#xD;
      well in the app. Compared to VAS score, the pain area index is differentiated in the body&#xD;
      planes and can represent a complementary and more specific source of information in&#xD;
      monitoring postoperative pain.&#xD;
&#xD;
      Aim of the study:&#xD;
&#xD;
      The study evaluates the NavigatePain app for monitoring the postoperative pain in patients&#xD;
      undergoing total ankle replacement, from preoperative condition to 30 days follow-up. The&#xD;
      indexes provided by the app in terms of percentages of pain areas are compared to VAS&#xD;
      reference score. Moreover, the relation between the percentage of pain area and the presence&#xD;
      of side effects of the intervention are compared as well.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      A sample of 70 subjects undergoing total ankle replacement surgery will be consecutively&#xD;
      enrolled. Age range will be 18 to 60 years. A user account will be created in the app for&#xD;
      every subject, allowing to acquire data immediately visible to the physician. Pain areas, VAS&#xD;
      score and presence of side effects will be acquired using the app at the following times: i)&#xD;
      the day before surgery, without drug administration; ii) day 1 after surgery; iii) day 2; iv)&#xD;
      day of hospital discharge (corresponding to day 3); v) day 7; vi) day 15; vii) day 30.&#xD;
      Monitorings from i) to iv) will be acquired during hospitalization using a dedicated tablet&#xD;
      device. In v), vi) and vii), the monitoring sessions will be notified to patients by the&#xD;
      automatic notification service of the app (via e-mail); in these cases, patients will use own&#xD;
      devices (e.g. PC, tablet or smartphone) to connect to account and perform drawing.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      The mean value of pain area index, and of VAS score will be compared over time and tested&#xD;
      according to one way ANOVA for repeated measurements.&#xD;
&#xD;
      The relation between pain area index and VAS will be assessed according to Pearson&#xD;
      correlation coefficient, or Spearman rank correlation in case of not normal distribution.&#xD;
      Statistical significance of the coefficients will be tested according to two-tailed t-test or&#xD;
      permutation distribution test assessing Pearson and Spearman coefficients, respectively.&#xD;
      Linear regression analysis will be performed as well.&#xD;
&#xD;
      The relation between pain area index and presence of side effects (expressed as dichotomic&#xD;
      variable: 1 in case of reported effects, 0 otherwise) will be tested according to point&#xD;
      biserial correlation coefficient.&#xD;
&#xD;
      Correlation coefficient and linear regression will be evaluated in each time session. The&#xD;
      results will be compared among the consecutive times in order to assess the potential&#xD;
      dependence on the follow-up time.&#xD;
&#xD;
      The sample size of 70 subjects has been verified to guarantee identifying statistically&#xD;
      significant differences in the mean value along the follow-up times (ANOVA test, one group,&#xD;
      seven repetitions, 0.05 level alpha, power 95%, expected correlation 0.5, effect size 0.15).&#xD;
      Moreover, the sample size guarantees identifying as significantly different from zero a&#xD;
      correlation value larger than 0.7 (i.e. strong correlation), by t-test at 0.05 level alpha&#xD;
      and power 95% (G*Power software, Universitat Dusseldorf, Germany).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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 area index</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Quantifies the percentage of pain area with respect to the total body area in the considered plane</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS score</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Continuous value ranging from 0 (minimum) to 10 (maximum), indicating the pain level reported by patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of side effects</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Dichotomic variable. Equal to 1 in case of reported side effects, 0 otherwise.</description>
  </primary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Ankle Osteoarthritis</condition>
  <condition>Pain, Postoperative</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects undergoing first implant of total ankle replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age from 18 to 60 years&#xD;
&#xD;
          -  ankle arthrosis grade 3 or 4, according to Kellgren-Lawrence classification&#xD;
&#xD;
          -  subject undergoing first implant of total ankle replacement&#xD;
&#xD;
          -  skeletal maturity&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous ankle replacement implants or ipsilateral ankle arthrodesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federico Federico, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Ortopedico Galeazzi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tito Bassani, PhD</last_name>
    <phone>+390266214939</phone>
    <email>tito.bassani@grupposandonato.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Federico Usuelli, MD</last_name>
    <phone>+39‭3357351838‬</phone>
    <email>fusuelli@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Irccs Istituto Ortopedico Galeazzi</name>
      <address>
        <city>Milan</city>
        <state>Milano</state>
        <zip>20156</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federico Usuelli, MD</last_name>
      <phone>+39‭3357351838‬</phone>
      <email>fusuelli@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Federico Usuelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Boudreau SA, Badsberg S, Christensen SW, Egsgaard LL. Digital Pain Drawings: Assessing Touch-Screen Technology and 3D Body Schemas. Clin J Pain. 2016 Feb;32(2):139-45. doi: 10.1097/AJP.0000000000000230.</citation>
    <PMID>25756558</PMID>
  </reference>
  <reference>
    <citation>Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.</citation>
    <PMID>2278111</PMID>
  </reference>
  <reference>
    <citation>Haeseler G, Schaefers D, Prison N, Ahrens J, Liu X, Karch A. Combatting pain after orthopedic/trauma surgery- perioperative oral extended-release tapentadol vs. extended-release oxycodone/naloxone. BMC Anesthesiol. 2017 Jul 11;17(1):91. doi: 10.1186/s12871-017-0383-6.</citation>
    <PMID>28693439</PMID>
  </reference>
  <reference>
    <citation>Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.</citation>
    <PMID>19302899</PMID>
  </reference>
  <reference>
    <citation>Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018.</citation>
    <PMID>29568700</PMID>
  </reference>
  <reference>
    <citation>Nett MP. Postoperative pain management. Orthopedics. 2010 Sep;33(9 Suppl):23-6. doi: 10.3928/01477447-20100722-60.</citation>
    <PMID>20839719</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Ankle Replacement</keyword>
  <keyword>Pain Measurement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03777072
org study id: ARP1
nct id: NCT03777072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates a novel web-based application for monitoring the postoperative pain in
      patients undergoing total ankle replacement, from preoperative condition to 30 days
      follow-up. The indexes provided by the app in terms of percentages of pain areas are compared
      with that obtained with traditional visual analogue scale. Moreover, the relation between the
      percentage of pain area and the presence of side effects of the intervention are compared as
      well.
Background:

      The management of postoperative pain in patients undergoing total ankle replacement is
      routinely based on one of the two following drugs: tapentadol and oxycodone/naloxone (Nett,
      2010). The drugs are used with similar frequencies. Indeed, previous studies compared the two
      drugs in terms of efficacy in reducing postoperative pain and frequency of side effects, in
      the field of orthopaedic and trauma surgery (Haeseler, 2017, Hartrick, 2009). The studies
      demonstrated that there are no substantial differences.

      With regard to pain monitoring, the gold standard is the visual-analogue scale (VAS), which
      allows the patient to indicate the pain level as a score ranging from 0 to 10 (from minimum
      to maximum) (Campbell, 1990). Recently, a pain monitoring web-based application has been
      developed and distributed: 'NavigatePain' (NavigatePain, Aglance Solutions, Denmark). The app
      can be used in a simple and intuitive manner by PC, smartphone or tablet devices (Boudreau,
      2016; Matthews, 2018). Moreover, physicians can easily schedule postoperative self-monitoring
      sessions for the patients (exploiting automatic notification messages sent by e-mail). The
      app allows the user to draw the pain areas in the frontal, posterior and lateral body planes,
      providing an index that quantifies the percentage of pain area with respect to the total body
      area in the considered plane. VAS score and notes reporting side effects can be reported as
      well in the app. Compared to VAS score, the pain area index is differentiated in the body
      planes and can represent a complementary and more specific source of information in
      monitoring postoperative pain.

      Aim of the study:

      The study evaluates the NavigatePain app for monitoring the postoperative pain in patients
      undergoing total ankle replacement, from preoperative condition to 30 days follow-up. The
      indexes provided by the app in terms of percentages of pain areas are compared to VAS
      reference score. Moreover, the relation between the percentage of pain area and the presence
      of side effects of the intervention are compared as well.

      Methods:

      A sample of 70 subjects undergoing total ankle replacement surgery will be consecutively
      enrolled. Age range will be 18 to 60 years. A user account will be created in the app for
      every subject, allowing to acquire data immediately visible to the physician. Pain areas, VAS
      score and presence of side effects will be acquired using the app at the following times: i)
      the day before surgery, without drug administration; ii) day 1 after surgery; iii) day 2; iv)
      day of hospital discharge (corresponding to day 3); v) day 7; vi) day 15; vii) day 30.
      Monitorings from i) to iv) will be acquired during hospitalization using a dedicated tablet
      device. In v), vi) and vii), the monitoring sessions will be notified to patients by the
      automatic notification service of the app (via e-mail); in these cases, patients will use own
      devices (e.g. PC, tablet or smartphone) to connect to account and perform drawing.

      Outcomes:

      The mean value of pain area index, and of VAS score will be compared over time and tested
      according to one way ANOVA for repeated measurements.

      The relation between pain area index and VAS will be assessed according to Pearson
      correlation coefficient, or Spearman rank correlation in case of not normal distribution.
      Statistical significance of the coefficients will be tested according to two-tailed t-test or
      permutation distribution test assessing Pearson and Spearman coefficients, respectively.
      Linear regression analysis will be performed as well.

      The relation between pain area index and presence of side effects (expressed as dichotomic
      variable: 1 in case of reported effects, 0 otherwise) will be tested according to point
      biserial correlation coefficient.

      Correlation coefficient and linear regression will be evaluated in each time session. The
      results will be compared among the consecutive times in order to assess the potential
      dependence on the follow-up time.

      The sample size of 70 subjects has been verified to guarantee identifying statistically
      significant differences in the mean value along the follow-up times (ANOVA test, one group,
      seven repetitions, 0.05 level alpha, power 95%, expected correlation 0.5, effect size 0.15).
      Moreover, the sample size guarantees identifying as significantly different from zero a
      correlation value larger than 0.7 (i.e. strong correlation), by t-test at 0.05 level alpha
      and power 95% (G*Power software, Universitat Dusseldorf, Germany).
observational model: Cohort
time perspective: Prospective
measure: Pain area index
time frame: Through study completion, an average of 18 months
description: Quantifies the percentage of pain area with respect to the total body area in the considered plane
measure: VAS score
time frame: Through study completion, an average of 18 months
description: Continuous value ranging from 0 (minimum) to 10 (maximum), indicating the pain level reported by patient.
measure: Presence of side effects
time frame: Through study completion, an average of 18 months
description: Dichotomic variable. Equal to 1 in case of reported side effects, 0 otherwise.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Federico Federico, MD
role: Principal Investigator
affiliation: IRCCS Istituto Ortopedico Galeazzi
last name: Tito Bassani, PhD
phone: +390266214939
email: tito.bassani@grupposandonato.it
last name: Federico Usuelli, MD
phone: +39‭3357351838‬
email: fusuelli@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Boudreau SA, Badsberg S, Christensen SW, Egsgaard LL. Digital Pain Drawings: Assessing Touch-Screen Technology and 3D Body Schemas. Clin J Pain. 2016 Feb;32(2):139-45. doi: 10.1097/AJP.0000000000000230.
PMID: 25756558
citation: Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.
PMID: 2278111
citation: Haeseler G, Schaefers D, Prison N, Ahrens J, Liu X, Karch A. Combatting pain after orthopedic/trauma surgery- perioperative oral extended-release tapentadol vs. extended-release oxycodone/naloxone. BMC Anesthesiol. 2017 Jul 11;17(1):91. doi: 10.1186/s12871-017-0383-6.
PMID: 28693439
citation: Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.
PMID: 19302899
citation: Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018.
PMID: 29568700
citation: Nett MP. Postoperative pain management. Orthopedics. 2010 Sep;33(9 Suppl):23-6. doi: 10.3928/01477447-20100722-60.
PMID: 20839719
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No