PainNCT05946239
Evaluating the Manage My Pain App in Pain Clinics
A study testing Manage My Pain App in people with Pain, run by University of Alberta at 1 site in Canada.
Trial summary
Chronic Pain is one of the most common reasons adults seek medical care, and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety and depression, and poor perceived health or reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Manage My Pain App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- On the Calgary Pain Clinic waitlist
Who cannot join
- Participants were excluded if they did not meet any of the above criteria
- Patients declining or unable to complete the consent process for the study
- No internet access
- No access to a device or computer to display the app/website
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Pain is one of the most common reasons adults seek medical care, and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety and depression, and poor perceived health or reduced quality of life. Chronic Pain Clinics are an effective solution, however, the resources available and investments have fallen behind the growing needs of patients. Local waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting. Tools and technology that can help patients and healthcare providers understand and manage the patients' pain are needed for the effectiveness of the healthcare system.
In response to this problem, the Manage My Pain (MMP) App, which allows patients to log daily reflections of functionality, pain, and medication use; as well as, provide educational resources is a potential support for patients on the waitlist. This log is intended to support the patient understanding and management of their pain, and share their reports with their circle of care.
This study will assess the impact of MMP on waitlist patients' health outcomes compared to a control group of waitlist patients over 60 days.
Read the detailed description
Chronic Pain is one of the most common reasons adults seek medical care and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety, depression, and poor perceived health or reduced quality of life. Currently, local pain clinic waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting for an appointment. To address this problem, this study assesses the impact of the MMP App to support the health and medication use of patients on the waitlist. Using this approach patients on the waitlist can use this app to report their pain, functionality, reflections, and medication use, as well as read educational resources about pain management.
This study tests the effectiveness of the MMP App versus a control group (i.e., standard practice) on health outcomes and mediation use over 60 days in a randomized control trial (RCT). The primary outcomes are pain, anxiety, pain self-efficacy, and quality of life. Secondary outcome is medication usage. Researchers will use descriptive and regression analysis to assess the data collected.
- Conditions
- Pain
- Being tested
- Manage My Pain App
- Keywords
- pain management, digital health, communication, quality of life, chronic pain, psychology, chronic disease management, anxiety, medication usage, patient oriented research
- Medical subject headings
- Pain, Agnosia, Communication, Chronic Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manage My Pain AppOther
This digital application helps patients measure, track, and manage chronic pain, functionality, and medication use. MMP can also be used to share patient pain experiences with their circle of care via reports and offers educational resources for patients.
| Study group | Role | What they receive |
|---|---|---|
| Manage My Pain App Intervention | Experimental | Participants will have access to the MMP App and standard care for 60 days. Receives: Other: Manage My Pain App |
| Control Group | No intervention | Participants will engage in standard care for 60 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol-5 Dimension-5 Levels (EQ5D5L)
EQ5D5L is a short descriptive questionnaire and a visual analogue scale that are simple to complete and assess five dimensions of quality of life including: mobility, selfcare, usual activities, pain/discomfort, and anxiety and depression (EuroQol, 2019). Each quality of life dimension will be assessed according to the following five level response scale, which varies in degree of severity from: no problem, light problem, moderate problems, severe problems, and unable to / extreme problems (EuroQol, 2019). The respondent will be asked to select the response item that most appropriately matches their current state (EuroQol, 2019). The single item score for each dimension is used assess the dimension, rather than a composite score. This instrument has been proven to be valid, reliable, and responsive in numerous conditions and populations (EuroQol, 2019; Finch et al., 2018).
Measured: 60 days
Generalized Anxiety Disorder (GAD-7)
The GAD-7 is a brief self-report assessment of anxiety severity for clinical practice and research (Spitzer et al., 2006). The GAD-7 consists of 7-items assessing anxiety on a four-point scale with response options including: not at all (score=0), several days (score=1), more than half the days (score=2), and nearly every day (score=3). To obtain the GAD-7 score, all scores are added to develop a total anxiety score. A score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and a score greater than 15 = severe anxiety (Plummer et al., 2016). To screen for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder (Plummer, et al 2016). The GAD-7 has been demonstrated to be a reliable and valid tool to detect generalized anxiety (Spitzer et al., 2006).
Measured: 60 days
Pain (Numeric Pain Rating Scale)
The Pain Numeric Rating Scale (NRS) is an 11 point scale that asks patients to identify the number between 0 (no pain at all) and 10 (the worst pain ever possible) that fits their pain intensity (McCaffery \& Beebe, 1989).
Measured: 60 days
Pain self-efficacy (PSEQ-4)
PSEQ-4 is an instrument to assess pain self-efficacy for clinical and research purposes (Chiarotto et al., 2016). The PSEQ-4 includes four items scored on a 7-point Likert scale ranging from not at all confident (score=0) to completely confident (score=6). Pain self-efficacy is calculated by summing the scores to determine a total score ranging from 0 to 24 (Chiarotto et al., 2016). High scores indicate greater pain self-efficacy. A systematic review has found that the PSEQ-4 has demonstrated excellent validity, reliability, and responsiveness among chronic lower back pain patients (Dubé et al., 2021). The PSEQ-4 may replace the full PSEQ and have similar responsiveness (Chiarotto et al., 2016).
Measured: 60 days
Secondary outcomes (1)
Medication Usage
A medication usage questionnaire used in pain clinics was modified with clinicians for this study. The survey asks if any of the listed medication (i.e.,Tramadol, Acetaminophen/ Codeine (Tylenol No 3, Hydromorphone, Hydromorphone Contin, Oxycodone 5mg/ Acetaminophen 325mg (Percocet), Oxycodone 5mg/Naloxone 10mg (Targin), Oxycodone, Oxycontin, Codeine, Morphine, Morphine Contin, Oxycodone, Oxycontin, Methadone, Fentanyl, Buprenorphine, Other Opioid) were taken in the last 7 days. If the medication was taken, the dose and frequency of administration was recorded.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start10 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial (RCT) using quantitative approaches will be undertaken to assess the impact of MMP on chronic pain clinic waitlist patient health outcomes prior to attending their first pain clinic appointment. This study will have 1 intervention group (access to MMP + standard care) and 1 control group (standard care). Participants will be randomly assigned to the intervention group or control group at a 2:1 ratio to account for variations in App usage.
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Bioscience Innovation Organization, Alberta Health services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946239
- Sponsor's protocol ID
- Pro00126058
- Status last verified
- Jan 2024
- First submitted
- 7 Jul 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima E Sa Resende F, Ostelo RW, Pillastrini P. Responsiveness and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. 2016 Jun;17(6):707-18. doi: 10.1016/j.jpain.2016.02.012. Epub 2016 Mar 11.
PubMed 26975193Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.
PubMed 34963996Finch AP, Brazier JE, Mukuria C. What is the evidence for the performance of generic preference-based measures? A systematic overview of reviews. Eur J Health Econ. 2018 May;19(4):557-570. doi: 10.1007/s10198-017-0902-x. Epub 2017 May 30.
PubMed 28560520Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
PubMed 16320034Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.
PubMed 26719105Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Pain: clinical manual for nursing practice Pain: clinical manual for nursing practice Margo McCaffery Alexander Beebe Mosby Yearbook UK pound17.25 0 7234 1992 2. Nurs Stand. 1994 Dec 7;9(11):55. doi: 10.7748/ns.9.11.55.s69.
PubMed 27527475
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Manage My Pain App in Pain Clinics
- ClinicalTrials.gov ID
- NCT05946239
- Acronym / sponsor ID
- Pro00126058
- Conditions
- Pain
- Keywords
- pain management, digital health, communication, quality of life, chronic pain, psychology, chronic disease management, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Ontario Bioscience Innovation Organization, Alberta Health services
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Pain is one of the most common reasons adults seek medical care, and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety and depression, and poor perceived health or reduced quality of life. Chronic Pain Clinics are an effective solution, however, the resources available and investments have fallen behind the growing needs of patients. Local waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting. Tools and technology that can help patients and healthcare providers understand and manage the patients' pain are needed for the effectiveness of the healthcare system.
In response to this problem, the Manage My Pain (MMP) App, which allows patients to log daily reflections of functionality, pain, and medication use; as well as, provide educational resources is a potential support for patients on the waitlist. This log is intended to support the patient understanding and management of their pain, and share their reports with their circle of care.
This study will assess the impact of MMP on waitlist patients' health outcomes compared to a control group of waitlist patients over 60 days.
Detailed description
Chronic Pain is one of the most common reasons adults seek medical care and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety, depression, and poor perceived health or reduced quality of life. Currently, local pain clinic waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting for an appointment. To address this problem, this study assesses the impact of the MMP App to support the health and medication use of patients on the waitlist. Using this approach patients on the waitlist can use this app to report their pain, functionality, reflections, and medication use, as well as read educational resources about pain management.
This study tests the effectiveness of the MMP App versus a control group (i.e., standard practice) on health outcomes and mediation use over 60 days in a randomized control trial (RCT). The primary outcomes are pain, anxiety, pain self-efficacy, and quality of life. Secondary outcome is medication usage. Researchers will use descriptive and regression analysis to assess the data collected.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial (RCT) using quantitative approaches will be undertaken to assess the impact of MMP on chronic pain clinic waitlist patient health outcomes prior to attending their first pain clinic appointment. This study will have 1 intervention group (access to MMP + standard care) and 1 control group (standard care). Participants will be randomly assigned to the intervention group or control group at a 2:1 ratio to account for variations in App usage.
| Arm | Type | Receives |
|---|---|---|
| Manage My Pain App Intervention | Experimental | Other: Manage My Pain AppParticipants will have access to the MMP App and standard care for 60 days. |
| Control Group | No intervention | –Participants will engage in standard care for 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- On the Calgary Pain Clinic waitlist
Key exclusion criteria (4 listed)
- Participants were excluded if they did not meet any of the above criteria
- Patients declining or unable to complete the consent process for the study
- No internet access
- No access to a device or computer to display the app/website
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manage My Pain AppThis digital application helps patients measure, track, and manage chronic pain, functionality, and medication use. MMP can also be used to share patient pain experiences with their circle of care via reports and offers educational resources for patients. | Other | Manage My Pain App Intervention |
Primary outcome
EuroQol-5 Dimension-5 Levels (EQ5D5L)
Time frame: 60 days
EQ5D5L is a short descriptive questionnaire and a visual analogue scale that are simple to complete and assess five dimensions of quality of life including: mobility, selfcare, usual activities, pain/discomfort, and anxiety and depression (EuroQol, 2019). Each quality of life dimension will be assessed according to the following five level response scale, which varies in degree of severity from: no problem, light problem, moderate problems, severe problems, and unable to / extreme problems (EuroQol, 2019). The respondent will be asked to select the response item that most appropriately matches their current state (EuroQol, 2019). The single item score for each dimension is used assess the dimension, rather than a composite score. This instrument has been proven to be valid, reliable, and responsive in numerous conditions and populations (EuroQol, 2019; Finch et al., 2018).
Generalized Anxiety Disorder (GAD-7)
Time frame: 60 days
The GAD-7 is a brief self-report assessment of anxiety severity for clinical practice and research (Spitzer et al., 2006). The GAD-7 consists of 7-items assessing anxiety on a four-point scale with response options including: not at all (score=0), several days (score=1), more than half the days (score=2), and nearly every day (score=3). To obtain the GAD-7 score, all scores are added to develop a total anxiety score. A score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and a score greater than 15 = severe anxiety (Plummer et al., 2016). To screen for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder (Plummer, et al 2016). The GAD-7 has been demonstrated to be a reliable and valid tool to detect generalized anxiety (Spitzer et al., 2006).
Pain (Numeric Pain Rating Scale)
Time frame: 60 days
The Pain Numeric Rating Scale (NRS) is an 11 point scale that asks patients to identify the number between 0 (no pain at all) and 10 (the worst pain ever possible) that fits their pain intensity (McCaffery \& Beebe, 1989).
Pain self-efficacy (PSEQ-4)
Time frame: 60 days
PSEQ-4 is an instrument to assess pain self-efficacy for clinical and research purposes (Chiarotto et al., 2016). The PSEQ-4 includes four items scored on a 7-point Likert scale ranging from not at all confident (score=0) to completely confident (score=6). Pain self-efficacy is calculated by summing the scores to determine a total score ranging from 0 to 24 (Chiarotto et al., 2016). High scores indicate greater pain self-efficacy. A systematic review has found that the PSEQ-4 has demonstrated excellent validity, reliability, and responsiveness among chronic lower back pain patients (Dubé et al., 2021). The PSEQ-4 may replace the full PSEQ and have similar responsiveness (Chiarotto et al., 2016).
1 secondary outcome
Medication Usage
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 26975193Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima E Sa Resende F, Ostelo RW, Pillastrini P. Responsiveness and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. 2016 Jun;17(6):707-18. doi: 10.1016/j.jpain.2016.02.012. Epub 2016 Mar 11.
- Background: PubMed 34963996Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.
- Background: PubMed 28560520Finch AP, Brazier JE, Mukuria C. What is the evidence for the performance of generic preference-based measures? A systematic overview of reviews. Eur J Health Econ. 2018 May;19(4):557-570. doi: 10.1007/s10198-017-0902-x. Epub 2017 May 30.
- Background: PubMed 16320034Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
- Background: PubMed 26719105Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 27527475Pain: clinical manual for nursing practice Pain: clinical manual for nursing practice Margo McCaffery Alexander Beebe Mosby Yearbook UK pound17.25 0 7234 1992 2. Nurs Stand. 1994 Dec 7;9(11):55. doi: 10.7748/ns.9.11.55.s69.
- EuroQol Research Foundation. (2019). EQ5D5L User GuideLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manage My Pain App in people with Pain, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol-5 Dimension-5 Levels (EQ5D5L) (time frame: 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05946239, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.