Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine I… (NCT05821699) | Clinical Trial Compass
CompletedNot Applicable
Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries
United States148 participantsStarted 2023-08-17
Plain-language summary
Patients experiencing sports medicine-related injuries are particularly vulnerable to developing both chronic pain and experiencing prolonged opioid use. This multiarmed randomized controlled trial will quantify the impact of integrating Life Care Specialists, and pain management-focused paraprofessionals, have on increasing access to multimodal pain management approaches and subsequently optimizing both patient-reported pain-related outcomes and objective measures of activity. Life Care Specialists work with patients and clinicians on implementing non-pharmacological pain management approaches, specifically teaching participants how to implement mindfulness-based skills into their recovery, systematically conducting standardized biopsychosocial pain assessments, and coordinating care. By developing a toolbox of pain management approaches with the support of the Life Care Specialist, patients are well positioned to incorporate evidence-based pain management approaches into their recovery that result in improved psychosocial functioning and reduced opioid medication utilization. In total, 150 individuals with sports medicine injuries will be randomized to one of two intervention arms where they will work with a Life Care Specialist in person or over telehealth or receive standard-of-care written postoperative instructions for pain management. Patient-reported outcomes, objective actigraphy movement outcomes captured using wrist-based watches, and opioid utilization captured using medication event monitoring system (MEMS) caps will be evaluated over 3-months postoperatively for a total of 4 study visits.
Who can participate
Age range
15 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults between 15-45 years old
* Scheduled for orthopedic surgery due to sports medicine injuries (e.g., anterior cruciate ligament tears, meniscus injury, rotator cuff injury, etc.), who are actively employed or full-time athletes before injury
Exclusion Criteria:
* Individuals unable to provide consent
* Those undergoing revision procedures
* Individuals without access to an internet-connected device
* Individuals who are unemployed or retired at the time of injury will be ineligible.
* Individuals who are incarcerated or pregnant will not be eligible.
* Individuals unable to communicate in English will be excluded since all surveys are validated in English.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used 'personalized pain coaches' after orthopaedic surgery — can you explain what that actually involved, and whether something similar is available as part of my care?
2Since this trial is now completed and was measuring both pain scores and opioid use, has the results data been published yet, and what did it show about whether pain coaching actually reduced opioid use after sports medicine surgery?
3This study was listed as Phase NA, meaning it wasn't testing a new drug but rather a care approach — does that mean there's less uncertainty about safety compared to a drug trial, or are there still risks I should understand?
4Given that this trial is already completed, is there a chance I could still benefit from what was learned — for example, could my post-surgical pain management plan be designed based on what this study found?
5Are there standard post-surgical pain management options already proven to work for my specific orthopaedic injury that I should consider alongside or instead of approaches like the one tested in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.