RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes

Quick Facts

Study Start:2023-08-17
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05821699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults between 15-45 years old
  2. * 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
  1. * Individuals unable to provide consent
  2. * Those undergoing revision procedures
  3. * Individuals without access to an internet-connected device
  4. * Individuals who are unemployed or retired at the time of injury will be ineligible.
  5. * Individuals who are incarcerated or pregnant will not be eligible.
  6. * Individuals unable to communicate in English will be excluded since all surveys are validated in English.

Contacts and Locations

Study Contact

Nicholas A Giordano, PhD
CONTACT
404.727.7980
nicholas.a.giordano@emory.edu

Principal Investigator

Nicholas A Giordano, PhD
PRINCIPAL_INVESTIGATOR
Assistant Professor

Study Locations (Sites)

Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Nicholas A Giordano, PhD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2023-08-17
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • Personalized Pain Coach
  • Postoperative outcome
  • Life Care Specialist

Additional Relevant MeSH Terms

  • Sports Medicine Injuries