Virtual Stepped Care Program for Chronic Pain

Recruiting at 10 trial locations

Overseen By Chitra Lalloo, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Cognitive impairments, Untreated psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online tool called the Power over Pain Portal, designed to help young people manage chronic pain. Chronic pain can lead to long-term mental health issues, and the trial aims to determine if the portal can improve access to care and reduce pain and mental health problems. The study involves Canadian youth with chronic pain who are waiting for specialist care. Participants must have internet access and be willing to use the portal for four months. This trial will assess the portal's effectiveness before it becomes widely available to all Canadian youth with chronic pain. As an unphased trial, it offers participants the chance to contribute to innovative research that could significantly improve chronic pain management for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an online program to help manage chronic pain, so you may not need to change your medication routine.

What prior data suggests that this virtual stepped care program is safe for youth with chronic pain?

Research shows that the Power over Pain Portal safely manages chronic pain. This online tool offers resources to help users manage pain and improve mental health. Studies have found that it provides easy access to useful information without known safety risks. Users report that it is easy to use and helps manage symptoms. No reports of negative effects have surfaced, making it a well-tolerated option for those with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Power over Pain Portal is unique because it uses a virtual stepped care approach to manage chronic pain. Traditional treatments often rely on medications like opioids or physical therapy, which can have limitations and side effects. This portal offers an innovative, digital solution that empowers patients to actively engage in their pain management through personalized, interactive content and resources. Researchers are excited about this approach because it has the potential to enhance accessibility, reduce reliance on medication, and provide tailored support to improve patient outcomes.

What evidence suggests that the Power over Pain Portal is effective for chronic pain?

Research has shown that the Power over Pain Portal, used by participants in this trial, is designed to help manage chronic pain by providing easy access to various resources. Studies have found that this online platform offers tools to assist users in managing pain and mental health. Early results suggest that the portal helps users track and understand symptoms such as mood, anxiety, and sleep. Its flexible, step-by-step approach allows users to receive support as needed. This program aims to improve access to care, which is especially important for young people dealing with chronic pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for Canadian youth experiencing chronic pain who are waiting for specialist care. Participants must be willing to use the Power over Pain Portal for 4 months, speak English or French, have internet access or accept a loaned phone with data, and be able to consent. Those with severe cognitive impairments or untreated major psychiatric illnesses are excluded.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I experience chronic pain.

Intend to use the PoP Portal for at least 4 months

Exclusion Criteria

I have difficulty understanding or using digital tools due to cognitive issues.

I don't have untreated major mental health issues or current suicidal thoughts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Power over Pain Portal for 4 months to manage chronic pain and mental health

16 weeks

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after using the Portal

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Power over Pain Portal

Trial Overview The study tests an online 'stepped care' program called the Power over Pain Portal designed for youths with chronic pain. It aims to tailor care based on individual needs and allows users to adjust the intensity of their treatment through the portal as required.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Power over Pain Portal

Power over Pain Portal is already approved in Canada for the following indications:

Approved in Canada as Power Over Pain Portal for:

• Chronic pain management in youth

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Children's Hospital of Eastern Ontario

Collaborator

Trials

134

Recruited

61,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Montreal Children's Hospital of the MUHC

Collaborator

Trials

32

Recruited

117,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Provincial Health Services Authority

Collaborator

Trials

40

Recruited

31,900+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Published Research Related to This Trial

The Empower Veterans Program (EVP) successfully helped 639 veterans with chronic pain by teaching them self-care skills over a 10-week period, with a graduation rate of 69.5% and high participant satisfaction (median rating of 8.41).

Participants reported significant improvements in pain intensity, interference, and catastrophizing, as well as enhancements in physical and psychological well-being, indicating that non-pharmacological approaches can effectively manage chronic pain in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empower Veterans Program (EVP): a chronic pain management program demonstrates positive outcomes among veterans. Haun, JN., Fowler, CA., Venkatachalam, HH., et al.[2023]

The implementation of the Stepped Care Model for Pain Management (SCM-PM) at a large Federally Qualified Health Center led to an 11% increase in primary care providers' knowledge about pain management and improved their confidence in treating pain.

The intervention resulted in significant improvements in pain assessment and management practices, including a 27.3% increase in the use of opioid treatment agreements and a 5.96% increase in referrals to behavioral health providers, indicating a more comprehensive approach to chronic pain care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving pain care through implementation of the Stepped Care Model at a multisite community health center. Anderson, DR., Zlateva, I., Coman, EN., et al.[2020]

A remotely delivered pain management program (vPMP) was successfully developed and implemented for patients with chronic musculoskeletal pain during the COVID-19 pandemic, involving 14 participants across three cycles.

Patient involvement was crucial in designing the vPMP and addressing challenges such as technical issues and communication, highlighting the importance of stakeholder engagement in remote healthcare solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid design and implementation of a virtual pain management programme due to COVID-19: a quality improvement initiative. Williams, D., Booth, G., Cohen, H., et al.[2022]

The ePEEP program, a telehealth adaptation of the Patient Education Empowerment Programme for chronic pain, was found to be acceptable and feasible for participants, indicating its potential as a valuable resource for pain management during the COVID-19 pandemic.

Participants reported significant benefits from ePEEP, including personal development, relationship building, and enhanced learning about pain, suggesting that telehealth can effectively support chronic pain management and empower individuals in their health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. Ernstzen, D., Keet, J., Louw, KA., et al.[2023]

The electronic Persistent Pain Outcomes Collaboration (ePPOC) has expanded to support over 100 adult and pediatric services in Australia and New Zealand since its inception in 2013, enhancing care for individuals with persistent pain.

Improvements in benchmarking, quality indicators, and research collaborations have strengthened the integration of quality improvement initiatives within pain services, contributing to a more comprehensive outcomes registry for persistent pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of outcomes: The evolution of an australasian outcomes collaboration for chronic pain services. Holloway, D., Allingham, S., Bryce, M., et al.[2023]

In a study involving 246 participants with chronic pain, the Manage My Pain (MMP) app was associated with lower anxiety levels and reduced pain catastrophizing, indicating its potential effectiveness in managing chronic pain alongside standard care.

Approximately 73.6% of participants agreed to use the app, and those who engaged with it reported significant improvements in mental health outcomes, suggesting that digital tools can enhance patient self-management in chronic pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. Bhatia, A., Kara, J., Janmohamed, T., et al.[2021]

Chronic pain is increasingly recognized as a significant public health issue, necessitating improved management strategies that address its complex nature and impact on patients and communities.

The P.A.I.N. Initiative has been established to enhance pain management quality through workshops for professionals, a software program for documenting patient data, an online discussion forum, and an education program for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. Morlion, B., Walch, H., Yihune, G., et al.[2011]

A new approach using Virtual Patients (VPs) for educating patients with chronic pain, specifically those with rheumatic disorders, received an excellent usability score of 88/100, indicating high satisfaction and effectiveness.

The positive feedback from participants suggests that this VP educational method can successfully empower patients with self-management skills and coping strategies for their chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of mobile scenario based learning in the self-management of chronic pain. Koulas, I., Billis, A., Kousouri, N., et al.[2021]

A scoping review identified 185 virtual care solutions for pediatric chronic pain, with a focus on self-guided apps and websites, indicating a strong availability of resources at lower levels of care.

Significant evidence gaps were found at higher levels of care, particularly in areas requiring more professional involvement, highlighting the need for improved integration with health records and support for various aspects of chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Evidence and Gap Map of virtual care solutions across a stepped care continuum for youth with chronic pain and their families in response to the COVID-19 pandemic. Birnie, KA., Pavlova, M., Neville, A., et al.[2023]

Over a four-year study period, the proportion of Veterans receiving high-dose opioids for chronic pain management decreased from 27.7% to 24.7%, indicating a positive shift towards safer opioid prescribing practices.

The implementation of the Stepped Care Model of Pain Management led to increased use of opioid risk mitigation strategies and referrals to non-opioid treatments like physical therapy and topical analgesics, aligning with evidence-based guidelines for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A partnered approach to opioid management, guideline concordant care and the stepped care model of pain management. Dorflinger, L., Moore, B., Goulet, J., et al.[2022]

The Reboot Online chronic pain program saw a 287% increase in registrations during the COVID-19 pandemic, indicating a significant rise in demand for online pain management services.

Despite the increase in participants during the pandemic, the program maintained similar adherence and effectiveness levels as before, with moderate improvements in pain-related outcomes, demonstrating its scalability and efficacy in addressing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Uptake and Effectiveness of a Multidisciplinary Online Program for Managing Chronic Pain before and During the COVID-19 Pandemic. Shiner, CT., Gardner, T., Haskelberg, H., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40998328/

Implementation and Effectiveness of the Power Over Pain ... The Power Over Pain (POP) Portal was developed by people living with CP, health care providers, researchers, health system decision-makers ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11915552/

Implementation-effectiveness of the power over pain portal ... The Power Over Pain (POP) Portal is a digital platform that provides people living with pain (PLWP) flexible access to chronic pain self-management resources.

3. researchprotocols.org researchprotocols.org/2025/1/e64801

Implementation and Effectiveness of the Power Over Pain ... The POP Portal offers rapid access to free, evidence-informed virtual resources and interventions for the self-management of CP, mental health, ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20552076251326229

Implementation-effectiveness of the power over pain portal ... The Power Over Pain (POP) Portal is a digital platform that provides people living with pain (PLWP) flexible access to chronic pain self-management resources.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06076889

Power Over Pain Portal: A Stepped-care Virtual Solution to ... The portal consists of self-assessment tools (bi-weekly check-ins to provide users with feedback on their mood, anxiety, pain, and sleep and guide decision ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511818/

Implementation and Effectiveness of the Power Over Pain ... The POP Portal (1) provides rapid access to free, evidence-informed virtual resources for CP, mental health, and substance use health arranged ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076241288748

Acceptability of the power over pain portal among patients ... We explored the POP Portal's acceptability, usability, and perceived usefulness among patients newly referred to a tertiary care pain clinic.