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

1000 Participants Needed

Trial Summary

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 data supports the effectiveness of the Pain Coach App treatment for postoperative pain in joint replacement surgery?

Research on similar mobile health applications, like Manage My Pain, shows that these apps can help patients track and communicate their pain effectively, which is important for managing postoperative pain. Additionally, a study on a virtual nursing intervention for postoperative pain management found that tailored, technology-based education can improve pain relief and patient empowerment. ^{1 2 3 4 5}

Is the Pain Coach App safe for use in humans?

The Pain Coach App and similar pain management apps have been generally well tolerated by users, with studies showing they are easy to use and satisfying for most patients. No specific safety concerns have been reported in the available research. ^{2 4 6 7 8}

How does the Pain Coach App treatment differ from other treatments for postoperative pain in joint replacement surgery?

The Pain Coach App is unique because it combines traditional education with a mobile application to guide patients in functional exercises and follow-up care, improving compliance and satisfaction compared to standard face-to-face or telephone education methods. ^{9 10 11 12 13}

What is the purpose of this trial?

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 Shoulder/Hip/Knee Arthroplasty surgery while maintaining the same or better pain control versus standard of care. The main questions it aims to answer are: 1. Will elective shoulder, hip and knee arthroplasty patients using PainCoach App be prescribed and/or use less opioids, measured by total morphine milliequivalents (MME) after surgery when compared to those treated as standard of care while maintaining similar pain control? 2. Will arthroplasty surgeons using PainCoach App write more patient-specific prescriptions resulting in a reduction in opioids prescribed after surgery with no increase in further opioids prescribed in the months following surgery? 3. Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery? 4. Will patients and surgeons using PainCoach App find it helpful enough to use it again and recommend to colleagues, family and friends? Researchers will compare participants assigned to use Pain Coach App vs participants assigned to standard of care arm to see if there are differences in opioid prescriptions and self reported use. Participants will either use the Pain Coach App or follow standard of care instructions and be followed forward for the opioid prescriptions dispensed in community and self-reported opioids use at study end.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessing the quality and usability of smartphone apps for pain self-management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. [2022]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient reported postoperative pain with a smartphone application: A proof of concept. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Mobile applications for pain management: an app analysis for clinical usage. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Longitudinal trial of a smartphone pain application for chronic pain patients: Predictors of compliance and satisfaction. [2018]

7. Canada 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

"There's a Pain App for That": Review of Patient-targeted Smartphone Applications for Pain Management. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[The mobile application of patient management in education and follow-up for patients following total knee arthroplasty]. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Acute pain management after orthopaedic surgery]. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Post-operative pain management in orthopaedic surgery and traumatology]. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The impact of a standard pain assessment protocol on pain levels and consumption of analgesia among postoperative orthopaedic patients. [2021]