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Efficacy of Pain Monitor, a Smartphone App for Chronic Pain

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ClinicalTrials.gov Identifier: NCT03247725
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Carlos Suso Ribera, Universitat Jaume I

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Chronic Pain Other: pain app Other: Treatment as usual (medical) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three conditions. Patients will be randomly assigned to one of the three conditions.
Masking: None (Open Label)
Masking Description: Patients will be informed of the condition they have been assigned to.
Primary Purpose: Treatment
Official Title: Pain Monitor: a Randomized Controlled Trial to Test the Efficacy of a Pain App in the Treatment of Chronic Pain
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Treatment as usual (waiting list)
Patients at this condition will receive the usual medical treatment at the pain unit, but they will not be monitored daily using the app.
Other: Treatment as usual (medical)
Patients will be offered the usual treatment for their pain, which is not changed by study participation

Experimental: Treatment as usual + app (without alarm)
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.
Other: pain app
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.

Other: Treatment as usual (medical)
Patients will be offered the usual treatment for their pain, which is not changed by study participation

Experimental: Treatment as usual + app (with alarm)
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.
Other: pain app
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.

Other: Treatment as usual (medical)
Patients will be offered the usual treatment for their pain, which is not changed by study participation




Primary Outcome Measures :
  1. Change in pain intensity [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    A numerical rating scale (0-10 range) will be used.

  2. Change in side effects [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    A list of the most frequent side effects of pain medication was created

  3. Change in pain intensity [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    A numerical rating scale (0-10 range) will be used.

  4. Change in side effects [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    A list of the most frequent side effects of pain medication was created


Secondary Outcome Measures :
  1. Change in mood [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    Questionnaire on mood validated against the Profile of Mood States

  2. Change in mood [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    Questionnaire on mood validated against the Profile of Mood States

  3. Change in rescue medication use [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    Amount of rescue medication will be assessed

  4. 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 ]
    Amount of rescue medication will be assessed

  5. Change in pain interference [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    Interference of pain with patient's life

  6. Change in pain interference [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    Interference of pain with patient's life

  7. Change in general health [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    A general health item was validated against the phsyical health scale of the Short Form 12

  8. Change in general health [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    A general health item was validated against the phsyical health scale of the Short Form 12

  9. Change in fear of pain [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    2 items validated against the Fear Avoidance Beliefs Scale

  10. 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 ]
    2 items validated against the Fear Avoidance Beliefs Scale

  11. Change in pain acceptance [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    2 items validated against the Chronic Pain Acceptance Questionnaire

  12. Change in pain acceptance [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    2 items validated against the Chronic Pain Acceptance Questionnaire

  13. Change in pain catastrophizing [ Time Frame: Dialy during 30 days (app condition) in the app condition (with and without alarm) ]
    3 items validated against the Pain Catastrophizing Scale

  14. Change in pain catastrophizing [ Time Frame: Twice (first day of study and 30 days after, at the end of study) in the TAU condition ]
    3 items validated against the Pain Catastrophizing Scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is over 18 years of age
  • The patient has a mobile phone with Android operating system
  • The patient has the physical ability to use the application
  • The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult
  • The patient voluntarily wants to participate and signs the informed consent

Exclusion Criteria:

  • The patient is under 18 years
  • The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons)
  • The patient does not have the physical capacity to use the application
  • The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language
  • The patient does not want to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247725


Locations
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Spain
Vall d'Hebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Universitat Jaume I
Investigators
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Principal Investigator: Ángela Mesas Idáñez, MD Staff Doctor

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlos Suso Ribera, Principal Investigator, Universitat Jaume I
ClinicalTrials.gov Identifier: NCT03247725     History of Changes
Other Study ID Numbers: UJI_PainMonitor
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the two principal investigators, Dr. Mesas and Dr. Suso, will be able to access to individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms