<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/NCT03247725</url>
  </required_header>
  <id_info>
    <org_study_id>UJI_PainMonitor</org_study_id>
    <nct_id>NCT03247725</nct_id>
  </id_info>
  <brief_title>Efficacy of Pain Monitor, a Smartphone App for Chronic Pain</brief_title>
  <official_title>Pain Monitor: a Randomized Controlled Trial to Test the Efficacy of a Pain App in the Treatment of Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Jaume I</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitat Jaume I</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 present investigation aims at exploring the effect of including a pain app called Pain&#xD;
      Monitor for chronic pain patients' daily monitoring. Three conditions will be set:&#xD;
&#xD;
        1. usual treatment (waiting list)&#xD;
&#xD;
        2. usual treatment + app (without alarms)&#xD;
&#xD;
        3. usual treatment + app (with alarms)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain is defined as one that lasts for at least three to six months, provided that&#xD;
      this time is greater than the normal healing period of an injury. This pathology has become&#xD;
      an important public health problem due to its high prevalence. In particular, it is estimated&#xD;
      that it affects 20-30% of the adult population around the world. Medical interventions are&#xD;
      the first-line treatment in recent clinical practice guidelines. Unfortunately, the&#xD;
      effectiveness of medical interventions is only modest. Treatments significantly reduce pain&#xD;
      on average, but the effect tends to be small . In addition, the drugs are not effective for a&#xD;
      large percentage of patients.&#xD;
&#xD;
      What these and other research suggest is that focusing only on large sample studies and the&#xD;
      use of average change scores calls into question the usefulness of current patient-centered&#xD;
      treatments. As noted by Dr. Turk, when data are averaged, various pain syndromes, drugs,&#xD;
      surgical procedures, and studies in different countries are often included, which may mask&#xD;
      the efficacy results of different treatments with Different samples. Single case methodology&#xD;
      could be one of the ways to overcome these limitations. The single case investigation is a&#xD;
      type of experimental study that offers experimental control within a single case.&#xD;
&#xD;
      Some studies have already demonstrated the usefulness of these designs in chronic pain. In&#xD;
      fact, the benefits of using this methodology as opposed to large sample studies were&#xD;
      discussed recently during the 10th Congress of the European Pain Federation. These benefits&#xD;
      include the need for a reduced number of participants, the ability to follow clinical&#xD;
      evolution in real time and continuously, the amount of data provided, and applicability when&#xD;
      using a control group is impractical or unethical.&#xD;
&#xD;
      The investigators conducting the present investigation recently conducted a study at the Pain&#xD;
      Unit of the Vall d'Hebron Hospital to explore the effectiveness of current medical&#xD;
      treatments. According to previous investigations, the treatment effect was only small (d =&#xD;
      0.32) and only a percentage of the patients (18.1%) had a clinically significant reduction of&#xD;
      pain (ie a reduction greater than 30% ).&#xD;
&#xD;
      From these results and the literature reviewed, a single case design could be an alternative&#xD;
      method for research in the Pain Unit. However, the implementation of this type of methodology&#xD;
      can be very costly due to the continuous evaluation of the evolution of the patient. In this&#xD;
      sense, several studies have already shown that mobile applications (app) can effectively&#xD;
      control the evolution of a wide range of pathologies in health settings . In fact, a recent&#xD;
      controlled clinical study found that ecological records performed with mobile app had greater&#xD;
      reliability than paper-and-pencil records.&#xD;
&#xD;
      Rosser and Eccleston conducted a comprehensive review of existing apps for pain and the&#xD;
      conclusion was that there was little evidence to support the use of current apps.&#xD;
      Specifically, these authors showed that most apps did not specify whether their content was&#xD;
      validated, did not include psychological components and none had been applied in a clinical&#xD;
      study. In light of these results, Dr. Carlos Suso Ribera and Dr. Ribera Canudas contacted the&#xD;
      research team Labpsitec of Jaume I University, who were developing an application for pain&#xD;
      called &quot;Pain Monitor&quot;. Dr. Carlos Suso Ribera and Dr. Ribera Canudas of the Pain Unit&#xD;
      collaborated with Dr. Azucena García Palacios and Dr. Diana Castilla López of the Universitat&#xD;
      Jaume I in the final development of the application of pain, Following the guidelines of&#xD;
      Rosser and Eccleston.&#xD;
&#xD;
      App content validity and usability was tested in a previous study at the pain unit of the&#xD;
      Vall d'Hebron Hospital (Suso-Ribera et al., in preparation). Thus, the study objective is to&#xD;
      test if the introduction of this tool in the day-to-day work of the pain unit improves pain&#xD;
      management of chronic pain patients. To do this, it is necessary to compare the evolution of&#xD;
      patients who follow the usual treatment at the pain unit (without app) with a group of&#xD;
      patients who do use the Pain Monitor app. In addition, the present study investigators have&#xD;
      created a new utility that allows alarms to be generated by healthcare professionals in the&#xD;
      presence of an undesired event, such as an adverse effect of the medication or a lack of&#xD;
      response to medical treatment. Before determining that both the use of the app and this new&#xD;
      utility (alarms) are beneficial for patient care, it is necessary to perform a clinical trial&#xD;
      comparing the 3 conditions mentioned above:&#xD;
&#xD;
        1. usual treatment (waiting list)&#xD;
&#xD;
        2. usual treatment + app (without alarms)&#xD;
&#xD;
        3. usual treatment + app (with alarms) Therefore, this is a clinical trial without drugs.&#xD;
           This is not an observational study since the physicians of patients in the app + alarms&#xD;
           condition will be asked to react to an alarm (i.e., if the patient has nausea for 3&#xD;
           consecutive days) by calling the patient and changing the treatment telematically, if&#xD;
           necessary, so that the patient can collect the prescription at his primary care center.&#xD;
&#xD;
      If the condition app with alarms results in a better treatment of chronic pain patients,&#xD;
      participants of the other two conditions will be offered the possibility to use the app with&#xD;
      alarms at the end of the study.&#xD;
&#xD;
      The study will be conducted at the Pain Unit of the Vall d'Hebron Hospital. All study&#xD;
      procedures have been approved by the ethical committee of the Vall d'Hebron Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>
    <intervention_model_description>Three conditions. Patients will be randomly assigned to one of the three conditions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients will be informed of the condition they have been assigned to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain intensity</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>A numerical rating scale (0-10 range) will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in side effects</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>A list of the most frequent side effects of pain medication was created</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain intensity</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>A numerical rating scale (0-10 range) will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in side effects</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>A list of the most frequent side effects of pain medication was created</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mood</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>Questionnaire on mood validated against the Profile of Mood States</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>Questionnaire on mood validated against the Profile of Mood States</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in rescue medication use</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>Amount of rescue medication will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in rescue medication use</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>Amount of rescue medication will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain interference</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>Interference of pain with patient's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain interference</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>Interference of pain with patient's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general health</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>A general health item was validated against the phsyical health scale of the Short Form 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general health</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>A general health item was validated against the phsyical health scale of the Short Form 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fear of pain</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>2 items validated against the Fear Avoidance Beliefs Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fear of pain</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>2 items validated against the Fear Avoidance Beliefs Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain acceptance</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>2 items validated against the Chronic Pain Acceptance Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain acceptance</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>2 items validated against the Chronic Pain Acceptance Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain catastrophizing</measure>
    <time_frame>Dialy during 30 days (app condition) in the app condition (with and without alarm)</time_frame>
    <description>3 items validated against the Pain Catastrophizing Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain catastrophizing</measure>
    <time_frame>Twice (first day of study and 30 days after, at the end of study) in the TAU condition</time_frame>
    <description>3 items validated against the Pain Catastrophizing Scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Treatment as usual (waiting list)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients at this condition will receive the usual medical treatment at the pain unit, but they will not be monitored daily using the app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual + app (without alarm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Because alarms will not be generated, physicians will not know if an undesired event is occuring despite the app is actually collecting data.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual + app (with alarm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Alarms will be generated in the face of certain preestablished events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pain app</intervention_name>
    <description>Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.</description>
    <arm_group_label>Treatment as usual + app (with alarm)</arm_group_label>
    <arm_group_label>Treatment as usual + app (without alarm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual (medical)</intervention_name>
    <description>Patients will be offered the usual treatment for their pain, which is not changed by study participation</description>
    <arm_group_label>Treatment as usual (waiting list)</arm_group_label>
    <arm_group_label>Treatment as usual + app (with alarm)</arm_group_label>
    <arm_group_label>Treatment as usual + app (without alarm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is over 18 years of age&#xD;
&#xD;
          -  The patient has a mobile phone with Android operating system&#xD;
&#xD;
          -  The patient has the physical ability to use the application&#xD;
&#xD;
          -  The patient does not present psychological and / or cognitive alterations or problems&#xD;
             with language that make their participation difficult&#xD;
&#xD;
          -  The patient voluntarily wants to participate and signs the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is under 18 years&#xD;
&#xD;
          -  The patient does not have a mobile phone or has a mobile phone in which Android is not&#xD;
             the operating system (the app is currently only available for Android for economic&#xD;
             reasons)&#xD;
&#xD;
          -  The patient does not have the physical capacity to use the application&#xD;
&#xD;
          -  The patient does not have the capacity to participate due to psychological and / or&#xD;
             cognitive alterations or problems with language&#xD;
&#xD;
          -  The patient does not want to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ángela Mesas Idáñez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Staff Doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vall d'Hebron Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Rosser BA, Eccleston C. Smartphone applications for pain management. J Telemed Telecare. 2011;17(6):308-12. doi: 10.1258/jtt.2011.101102. Epub 2011 Aug 15.</citation>
    <PMID>21844177</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitat Jaume I</investigator_affiliation>
    <investigator_full_name>Carlos Suso Ribera</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>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only the two principal investigators, Dr. Mesas and Dr. Suso, will be able to access to individual participant data.</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/NCT03247725
org study id: UJI_PainMonitor
nct id: NCT03247725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present investigation aims at exploring the effect of including a pain app called Pain
      Monitor for chronic pain patients' daily monitoring. Three conditions will be set:

        1. usual treatment (waiting list)

        2. usual treatment + app (without alarms)

        3. usual treatment + app (with alarms)
Chronic pain is defined as one that lasts for at least three to six months, provided that
      this time is greater than the normal healing period of an injury. This pathology has become
      an important public health problem due to its high prevalence. In particular, it is estimated
      that it affects 20-30% of the adult population around the world. Medical interventions are
      the first-line treatment in recent clinical practice guidelines. Unfortunately, the
      effectiveness of medical interventions is only modest. Treatments significantly reduce pain
      on average, but the effect tends to be small . In addition, the drugs are not effective for a
      large percentage of patients.

      What these and other research suggest is that focusing only on large sample studies and the
      use of average change scores calls into question the usefulness of current patient-centered
      treatments. As noted by Dr. Turk, when data are averaged, various pain syndromes, drugs,
      surgical procedures, and studies in different countries are often included, which may mask
      the efficacy results of different treatments with Different samples. Single case methodology
      could be one of the ways to overcome these limitations. The single case investigation is a
      type of experimental study that offers experimental control within a single case.

      Some studies have already demonstrated the usefulness of these designs in chronic pain. In
      fact, the benefits of using this methodology as opposed to large sample studies were
      discussed recently during the 10th Congress of the European Pain Federation. These benefits
      include the need for a reduced number of participants, the ability to follow clinical
      evolution in real time and continuously, the amount of data provided, and applicability when
      using a control group is impractical or unethical.

      The investigators conducting the present investigation recently conducted a study at the Pain
      Unit of the Vall d'Hebron Hospital to explore the effectiveness of current medical
      treatments. According to previous investigations, the treatment effect was only small (d =
      0.32) and only a percentage of the patients (18.1%) had a clinically significant reduction of
      pain (ie a reduction greater than 30% ).

      From these results and the literature reviewed, a single case design could be an alternative
      method for research in the Pain Unit. However, the implementation of this type of methodology
      can be very costly due to the continuous evaluation of the evolution of the patient. In this
      sense, several studies have already shown that mobile applications (app) can effectively
      control the evolution of a wide range of pathologies in health settings . In fact, a recent
      controlled clinical study found that ecological records performed with mobile app had greater
      reliability than paper-and-pencil records.

      Rosser and Eccleston conducted a comprehensive review of existing apps for pain and the
      conclusion was that there was little evidence to support the use of current apps.
      Specifically, these authors showed that most apps did not specify whether their content was
      validated, did not include psychological components and none had been applied in a clinical
      study. In light of these results, Dr. Carlos Suso Ribera and Dr. Ribera Canudas contacted the
      research team Labpsitec of Jaume I University, who were developing an application for pain
      called "Pain Monitor". Dr. Carlos Suso Ribera and Dr. Ribera Canudas of the Pain Unit
      collaborated with Dr. Azucena García Palacios and Dr. Diana Castilla López of the Universitat
      Jaume I in the final development of the application of pain, Following the guidelines of
      Rosser and Eccleston.

      App content validity and usability was tested in a previous study at the pain unit of the
      Vall d'Hebron Hospital (Suso-Ribera et al., in preparation). Thus, the study objective is to
      test if the introduction of this tool in the day-to-day work of the pain unit improves pain
      management of chronic pain patients. To do this, it is necessary to compare the evolution of
      patients who follow the usual treatment at the pain unit (without app) with a group of
      patients who do use the Pain Monitor app. In addition, the present study investigators have
      created a new utility that allows alarms to be generated by healthcare professionals in the
      presence of an undesired event, such as an adverse effect of the medication or a lack of
      response to medical treatment. Before determining that both the use of the app and this new
      utility (alarms) are beneficial for patient care, it is necessary to perform a clinical trial
      comparing the 3 conditions mentioned above:

        1. usual treatment (waiting list)

        2. usual treatment + app (without alarms)

        3. usual treatment + app (with alarms) Therefore, this is a clinical trial without drugs.
           This is not an observational study since the physicians of patients in the app + alarms
           condition will be asked to react to an alarm (i.e., if the patient has nausea for 3
           consecutive days) by calling the patient and changing the treatment telematically, if
           necessary, so that the patient can collect the prescription at his primary care center.

      If the condition app with alarms results in a better treatment of chronic pain patients,
      participants of the other two conditions will be offered the possibility to use the app with
      alarms at the end of the study.

      The study will be conducted at the Pain Unit of the Vall d'Hebron Hospital. All study
      procedures have been approved by the ethical committee of the Vall d'Hebron Hospital.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three conditions. Patients will be randomly assigned to one of the three conditions.
primary purpose: Treatment
masking: None (Open Label)
masking description: Patients will be informed of the condition they have been assigned to.
measure: Change in pain intensity
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: A numerical rating scale (0-10 range) will be used.
measure: Change in side effects
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: A list of the most frequent side effects of pain medication was created
measure: Change in pain intensity
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: A numerical rating scale (0-10 range) will be used.
measure: Change in side effects
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: A list of the most frequent side effects of pain medication was created
measure: Change in mood
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: Questionnaire on mood validated against the Profile of Mood States
measure: Change in mood
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: Questionnaire on mood validated against the Profile of Mood States
measure: Change in rescue medication use
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: Amount of rescue medication will be assessed
measure: Change in rescue medication use
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: Amount of rescue medication will be assessed
measure: Change in pain interference
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: Interference of pain with patient's life
measure: Change in pain interference
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: Interference of pain with patient's life
measure: Change in general health
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: A general health item was validated against the phsyical health scale of the Short Form 12
measure: Change in general health
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: A general health item was validated against the phsyical health scale of the Short Form 12
measure: Change in fear of pain
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: 2 items validated against the Fear Avoidance Beliefs Scale
measure: Change in fear of pain
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: 2 items validated against the Fear Avoidance Beliefs Scale
measure: Change in pain acceptance
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: 2 items validated against the Chronic Pain Acceptance Questionnaire
measure: Change in pain acceptance
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: 2 items validated against the Chronic Pain Acceptance Questionnaire
measure: Change in pain catastrophizing
time frame: Dialy during 30 days (app condition) in the app condition (with and without alarm)
description: 3 items validated against the Pain Catastrophizing Scale
measure: Change in pain catastrophizing
time frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition
description: 3 items validated against the Pain Catastrophizing Scale
arm group label: Treatment as usual (waiting list)
arm group type: Active Comparator
description: Patients at this condition will receive the usual medical treatment at the pain unit, but they will not be monitored daily using the app.
arm group label: Treatment as usual + app (without alarm)
arm group type: Experimental
description: Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Because alarms will not be generated, physicians will not know if an undesired event is occuring despite the app is actually collecting data.
arm group label: Treatment as usual + app (with alarm)
arm group type: Experimental
description: Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Alarms will be generated in the face of certain preestablished events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.
intervention type: Other
intervention name: pain app
description: Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.
arm group label: Treatment as usual + app (with alarm)
arm group label: Treatment as usual + app (without alarm)
intervention type: Other
intervention name: Treatment as usual (medical)
description: Patients will be offered the usual treatment for their pain, which is not changed by study participation
arm group label: Treatment as usual (waiting list)
arm group label: Treatment as usual + app (with alarm)
arm group label: Treatment as usual + app (without alarm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ángela Mesas Idáñez, MD
role: Principal Investigator
affiliation: Staff Doctor
facility: 
country: Spain
citation: Rosser BA, Eccleston C. Smartphone applications for pain management. J Telemed Telecare. 2011;17(6):308-12. doi: 10.1258/jtt.2011.101102. Epub 2011 Aug 15.
PMID: 21844177
responsible party type: Principal Investigator
investigator affiliation: Universitat Jaume I
investigator full name: Carlos Suso Ribera
investigator title: Principal Investigator
mesh term: Chronic Pain
sharing ipd: No
ipd description: Only the two principal investigators, Dr. Mesas and Dr. Suso, will be able to access to individual participant data.