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Personalized Pain Coaching for Sports Injuries

N/A

Recruiting

Led By Nicholas A Giordano, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

Awards & highlights

Study Summary

This trial will study how Life Care Specialists, who help patients manage pain without opioids, can improve outcomes for sports medicine-related injuries.

Who is the study for?

This trial is for adults aged 18-45 who are scheduled for orthopedic surgery due to sports injuries and were either working or full-time athletes before getting hurt. They must have a BMI under 40. It's not open to those unable to consent, without internet device access, unemployed/retired at injury time, incarcerated/pregnant individuals, or non-English speakers.Check my eligibility

What is being tested?

The study tests if Life Care Specialists (pain coaches) can help patients manage pain better after sports-related surgeries compared to standard care instructions. Patients will be randomly assigned to work with these specialists in person or via telehealth or receive usual written instructions.See study design

What are the potential side effects?

Since the intervention involves non-pharmacological approaches like mindfulness and biopsychosocial assessments rather than medications, there may not be typical drug side effects; however, some participants might experience discomfort adjusting to new pain management techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes Pain numerical rating scale (NRS)

Changes to Opioid utilization

Secondary outcome measures

Changes in Mindful Attention Awareness Scale (MAAS)

Changes in Opioid Overdose Knowledge Scale (OOKS)

Changes to Actigraphy based sleep and activity data

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Virtual LCS Intervention-With Opioid Risk EducationExperimental Treatment1 Intervention

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 II: In Person LCS Intervention- With Opioid Risk EducationExperimental Treatment1 Intervention

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 III: No LCS interventionActive Control1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,507 Total Patients Enrolled

National Football LeagueOTHER

7 Previous Clinical Trials

1,742 Total Patients Enrolled

Nicholas A Giordano, PhDPrincipal InvestigatorAssistant Professor

Media Library

Life Care Specialist Clinical Trial Eligibility Overview. Trial Name: NCT05821699 — N/A

Sports Injuries Research Study Groups: Virtual LCS Intervention-With Opioid Risk Education, No LCS intervention, In Person LCS Intervention- With Opioid Risk Education

Sports Injuries Clinical Trial 2023: Life Care Specialist Highlights & Side Effects. Trial Name: NCT05821699 — N/A

Life Care Specialist 2023 Treatment Timeline for Medical Study. Trial Name: NCT05821699 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the prerequisites of participation in this medical experiment?

"Prospective participants in this clinical trial need to have sustained a sports injury and must fall within the 18-45 age range. At present, 150 individuals are sought after for enrollment."

Answered by AI

Is the criterion for accepting participants limited to those aged 80 or younger?

"This trial is available to individuals aged 18-45; however, there are 134 separate trials specifically for those under 18 and 628 trials tailored towards the elderly."

Answered by AI

Is recruitment still underway for this research?

"According to clinicaltrials.gov, the recruitment of participants for this medical trial has been suspended since April 7th 2023. However, there are many other studies that remain open and actively recruiting patients."

Answered by AI

What aims is this research attempting to accomplish?

"This medical study aspires to assess Changes in Opioid Utilization, and also observe participants' PROMIS scores (Sleep Disturbance, Physical Function, Pain Interference, Prescription Pain Medication Misuse) on a Likert scale from 5-1. Additionally this research aims to evaluate Mindful Attention Awareness Scale (MAAS), and record Actigraphy based sleep and activity data across a one month preoperative period, two week postoperative timeline, six week time frame after surgery and three months of recovery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Nicholas A. Giordano 2023. "Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05821699.