Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries

NCT ID: NCT05821699

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2025-11-30

Brief 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.

Detailed Description

Longitudinal analyses indicate that both greater pain severity and duration precede poor functioning and prolonged opioid use. This finding suggests that optimizing pain management, soon after painful events, such as orthopaedic injury, is vital to reducing risks related to prolonged opioid use. However, opioid-dominant pain management, which remains the standard of care across many health systems and in orthopaedic surgery, elevates the risks for ineffective pain management and, subsequently, opioid dependency by only targeting a select number of pain receptors.

Multimodal analgesia, which combines analgesic drugs from different classes and employs analgesic techniques that target multiple pain-related receptors, is recommended in the treatment of acute postoperative pain because its synergistic effect maximizes pain relief at lower analgesic doses, thereby reducing the risk of adverse opioid-related effects and chronic pain.

The study team's interdisciplinary team has developed and tested a novel clinical care team role focused on optimizing pain management after surgery, known as a Life Care Specialist. Life Care Specialists provide patient-centered pain management care coordination, teach patients how to implement non-pharmacological pain management approaches, and deliver opioid safety-focused pain education, not only during acute hospitalization but also throughout postoperative recovery.

Life Care Specialists provide pain-focused care coordination for patients with complex needs after orthopedic injury, including communicating patient care needs and goals of care to clinical care team members (e.g. surgeons, acute pain service, physical therapy, nursing staff), connecting patients to yoga instructors, massage therapists, and engaging behavioral health consults to work with patients over time to improve biopsychosocial pain presentations.

For this trial, 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 MEMS caps will be evaluated over 3-months postoperatively for a total of 4 study visits.

Conditions

Sports Medicine Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

In Person LCS Intervention- With Opioid Risk Education

Patients will receive opioid education and Naloxone education. Therapeutic Intervention will include education on implementing mindfulness practices into postoperative recovery, known as the Community Resiliency Model CRM). Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. All participants in the LCS intervention arm will also receive the current standard-of-care. The Community Resiliency Model (CRM) is a noncognitive variant of mindfulness, emphasizing attunement to interoceptive and exteroceptive signaling cues for regulation of autonomic responses to stress. CRM skills are introduced over a sixty-to-ninety-minute session, allowing for a brief introduction and application of skills by participants. These will be in person.

Group Type: EXPERIMENTAL

LCS (Life Care Specialist)

Intervention Type: BEHAVIORAL

The LCS will work with the patient to create a pain management plan focused on behavioral education. The LCS interventions can encompass all, but not limited to, the information included below:

• Opioid Risk Education
• Therapeutic Intervention
• Clinical Pain Coordination

Virtual LCS Intervention-With Opioid Risk Education

Participants will receive opioid education, and Naloxone education. Therapeutic Intervention will include education on implementing mindfulness practices into postoperative recovery, known as the Community Resiliency Model CRM). Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. All participants in the LCS intervention arm will also receive the current standard-of-care. The Community Resiliency Model (CRM) is a noncognitive variant of mindfulness, emphasizing attunement to interoceptive and exteroceptive signaling cues for regulation of autonomic responses to stress. CRM skills are introduced over a sixty-to-ninety-minute session, allowing for a brief introduction and application of skills by participants. These will be in performed virtually via a digital conferencing platform

Group Type: EXPERIMENTAL

LCS (Life Care Specialist)

Intervention Type: BEHAVIORAL

The LCS will work with the patient to create a pain management plan focused on behavioral education. The LCS interventions can encompass all, but not limited to, the information included below:

• Opioid Risk Education
• Therapeutic Intervention
• Clinical Pain Coordination

No LCS intervention

Patients will receive the current standard-of-care for pain management in the aftermath of surgery, which includes: a standardized prescription protocol, hospital-system approved discharge instructions which provide written instruction on how to taper opioid use, links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Patients will receive the current standard-of-care for pain management in the aftermath of surgery: a standardized prescription protocol, hospital-system approved discharge instructions which provide written instruction on how to taper opioid use, links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.

Interventions

LCS (Life Care Specialist)

The LCS will work with the patient to create a pain management plan focused on behavioral education. The LCS interventions can encompass all, but not limited to, the information included below:

• Opioid Risk Education
• Therapeutic Intervention
• Clinical Pain Coordination

Intervention Type: BEHAVIORAL

Standard of Care

Patients will receive the current standard-of-care for pain management in the aftermath of surgery: a standardized prescription protocol, hospital-system approved discharge instructions which provide written instruction on how to taper opioid use, links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Football League

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas A. Giordano

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas A Giordano, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicholas A Giordano, PhD

Role: CONTACT

nicholas.a.giordano@emory.edu

404.727.7980

Facility Contacts

Nicholas A Giordano, PhD

Role: primary

nicholas.a.giordano@emory.edu

404.727.7980

Nicholas A Giordano, PhD

Role: primary

nicholas.a.giordano@emory.edu

404.727.7980

Other Identifiers

STUDY00004925

Identifier Type: -

Identifier Source: org_study_id