Pain Coach App for Postoperative Pain in Joint Replacement Surgery

Overseen By Emily Johnston, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Non-elective surgery, Bilateral arthroplasty, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 8

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new Pain Coach App can help patients undergoing elective shoulder, hip, or knee replacement surgery use fewer opioids while maintaining or improving pain relief. The researchers aim to determine if the app can lead to more personalized and reduced opioid prescriptions, potentially decreasing healthcare use after surgery. Participants will either use the Pain Coach App or follow standard care to assess any differences in opioid use. Ideal candidates have scheduled elective joint surgeries and can use a smartphone with internet access. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgical care and pain management.

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 focuses on using the Pain Coach App to manage opioid prescriptions after surgery.

What prior data suggests that the Pain Coach App is safe for postoperative pain management in joint replacement surgery?

Research has shown that the Pain Coach App is generally safe for individuals undergoing joint replacement surgery. One study found that patients using the app did not experience more pain than those who did not use it. In fact, they used 23.2% fewer opioid painkillers, suggesting the app effectively manages pain with less medication. Using fewer opioids often results in fewer side effects, indicating the app is well-tolerated.

Another study found that patients enjoy using digital health tools like the Pain Coach App, finding it engaging and easy to use. So far, research has not identified any serious safety issues with the app, suggesting it could be a safe option for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pain Coach App for managing postoperative pain in joint replacement surgery because it offers a new, tech-driven approach to pain management. Unlike the standard of care, which often involves medications and traditional support systems, this app empowers patients with personalized pain management guidance directly through their mobile devices. By providing real-time feedback and tailored strategies, the app aims to enhance recovery and potentially reduce reliance on pain medications. This innovative use of technology could revolutionize how patients experience postoperative care, making recovery more efficient and less dependent on pharmaceuticals.

What evidence suggests that the Pain Coach App is effective for reducing opioid use after joint replacement surgery?

Studies have shown that the Pain Coach App, available to participants in this trial, can effectively manage pain after joint replacement surgery. Research indicates that patients using the app often require fewer opioid painkillers while still managing their pain well, compared to those receiving standard care. Initial findings suggest that the app helps adjust prescriptions, ensuring patients receive the right amount of medication. This could result in fewer leftover pills and a reduced chance of needing more opioids later. Overall, the Pain Coach App offers a promising method to manage post-surgery pain with less reliance on opioids. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients scheduled for elective shoulder, hip, or knee arthroplasty within NSH. Participants must be able to access the internet on a mobile device and read/write in English. Those with low tech skills may join if they have support available.

Inclusion Criteria

Able to access the internet via mobile device (has access to smart phone)

If expresses concern about low tech IQ, has a support person available

Able to read and write in English

Exclusion Criteria

Unable to read or write in English

No access to internet or mobile device to use self-help pain management tools

I had surgery for a joint due to an injury or fracture.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either use the Pain Coach App or follow standard care instructions post-surgery

3 months

Post Op Day 2 and 30 assessments

Follow-up

Participants are monitored for opioid prescriptions and healthcare system interactions

6 months

Retrospective chart review at 6 months

Extension

Interim analysis to determine if the study should end early based on significant differences

Until 561 participants per group

What Are the Treatments Tested in This Trial?

Interventions

• Pain Coach App

Trial Overview The study tests whether the Pain Coach App can reduce opioid prescriptions and usage after joint replacement surgery while maintaining effective pain control compared to standard care. It will also evaluate patient and surgeon satisfaction with the app.

How Is the Trial Designed?

Group I: Pain Coach App Users Experimental Treatment 1 Intervention

Participants enrolled in Pain Coach App software and directed to download on their mobile device

Group II: Standard of Care Active Control 1 Intervention

Participants received traditional standard of care supports for joint arthroplasty surgery

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

A study evaluated 12 smartphone apps for self-managing pain, revealing significant differences in their quality, clinical content, and usability, with little user or clinician involvement in their development.

Usability testing showed that users preferred lighter color schemes and specific text fonts, highlighting the need for greater user engagement in app design to improve their effectiveness for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the quality and usability of smartphone apps for pain self-management. Reynoldson, C., Stones, C., Allsop, M., et al.[2022]

The SOULAGE-TAVIE intervention, a tailored Web-based program for postoperative pain management, was developed and validated through a structured process involving 30 cardiac surgery patients over 4 months, showing high acceptability with 96% of participants finding the strategies helpful.

This innovative approach emphasizes patient empowerment and personalized education, suggesting that using technology can enhance the effectiveness of pain management strategies in a complex healthcare environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOULAGE-TAVIE: development and validation of a virtual nursing intervention to promote self-management of postoperative pain after cardiac surgery. Martorella, G., Côté, J., Choinière, M.[2022]

The smartphone pain app was well tolerated and easily introduced among 90 chronic pain patients over a six-month trial, with no safety issues reported.

While greater use of the app correlated with improved mood and satisfaction, it did not lead to significant improvements in pain levels or activity, suggesting the need for strategies to enhance user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal trial of a smartphone pain application for chronic pain patients: Predictors of compliance and satisfaction. Jamison, RN., Mei, A., Ross, EL.[2018]

Among the 393 veterans surveyed, those who used the Pain Coach app reported significantly greater pain self-efficacy and lower pain interference after using the app, indicating its potential effectiveness in managing chronic pain.

Despite the positive outcomes, only 10.2% of veterans used the app, with the main barrier being a lack of discussion about the app by their healthcare teams, highlighting the need for better communication and endorsement from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Adoption and Preliminary Effectiveness of a Mobile App for Chronic Pain Management Among US Military Veterans: Pre-Post Mixed Methods Evaluation. Hogan, TP., Etingen, B., McMahon, N., et al.[2022]

The mobile health platform Manage My Pain was well-accepted by patients at the Transitional Pain Service, with 67% of participants consenting to use it and 61% completing registration, indicating its potential as a valuable tool for pain self-management.

User retention rates were promising, with 67.9% of users continuing to engage with the app after 30 days and 43.2% after 90 days, suggesting that the app effectively supports ongoing pain monitoring and communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. Slepian, PM., Peng, M., Janmohamed, T., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06469177

Patient Centered Post-Op Pain Management Software Tool ... The goal of this clinical trial is to learn if the Pain Coach App will result in less opioids being prescribed to and used by patients undergoing ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32167483/

Effectiveness of a Mobile eHealth App in Guiding Patients ... The aim of this paper was to investigate the effects of the PainCoach app on pain control and opiate use in patients who underwent TKR during the first 2 weeks ...

3. withpower.com withpower.com/trial/pain-coach-app-for-postoperative-pain-in-joint-replacement-surgery-b0a4c

Pain Coach App for Postoperative Pain in Joint ... Trial Overview The study tests whether the Pain Coach App can reduce opioid prescriptions and usage after joint replacement surgery while maintaining effective ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7101497/

Effectiveness of a Mobile eHealth App in Guiding Patients ... The results of this study show that the PainCoach app is a successful pain management ... joint replacement surgery. J Clin Nurs. 2012 Mar ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809608

Combined Digital Interventions for Pain Reduction in ... In this randomized clinical trial, a combined digital technology program provided small but not clinically meaningful improvements in pain at 3 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9531001/

Postoperative Outcomes of a Digital Rehabilitation ... Our digital musculoskeletal surgical care program shows promising levels of engagement and acceptability among those who recently underwent total knee ...