150 Participants Needed

Personalized Pain Coaching for Sports Injuries

Recruiting at 1 trial location
NA
Overseen ByNicholas A Giordano, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 non-drug pain management approaches, so it's best to discuss your specific situation with the trial coordinators.

Is personalized pain coaching for sports injuries safe for humans?

The research does not provide specific safety data for personalized pain coaching, but it highlights that pain management in sports often involves non-drug methods like compression and cryotherapy, which are generally safe. It also notes that some pain medications can have side effects, especially in athletes, suggesting the importance of careful management to minimize harm.12345

How is the Personalized Pain Coaching treatment for sports injuries different from other treatments?

Personalized Pain Coaching for sports injuries is unique because it focuses on a biopsychosocial approach, which considers not just the physical aspects of pain but also psychological and social factors, unlike traditional treatments that often focus solely on physical recovery.25678

What data supports the effectiveness of the treatment 'Personalized Pain Coaching for Sports Injuries'?

Research suggests that personalized care and self-management interventions can be beneficial for managing chronic pain, as seen in studies involving physiotherapist-led rehabilitation and pain self-management frameworks. These approaches emphasize individualized care and support, which may also be effective for sports injuries.910111213

Who Is on the Research Team?

NA

Nicholas A Giordano, PhD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for surgery due to a sports injury and was working or an athlete before getting hurt.
BMI <40 will be eligible.

Exclusion Criteria

I am unable to give consent by myself.
I am scheduled for a corrective surgical procedure.
Individuals without access to an internet connected device
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Participants undergo pre-surgery assessments and preparation, including baseline measurements for outcome measures

1 month

Treatment

Participants receive postoperative pain management interventions, including working with Life Care Specialists and standard-of-care instructions

3 months
4 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, opioid use, and functional outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Life Care Specialist
  • Standard of Care
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Virtual LCS Intervention-With Opioid Risk EducationExperimental Treatment1 Intervention
Group II: In Person LCS Intervention- With Opioid Risk EducationExperimental Treatment1 Intervention
Group III: No LCS interventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Football League

Collaborator

Trials
8
Recruited
2,000+

Published Research Related to This Trial

A physiotherapist-led rehabilitation program consisting of nine sessions over five months resulted in clinically significant improvements in pain, disability, and overall health for 45% of patients at discharge and similar results at one-year follow-up.
The program included individualized education, sensorimotor training, and physical activity advice, demonstrating effectiveness even in patients who had not responded to previous treatments, suggesting the need for further research to tailor interventions for specific patient subgroups.
Physiotherapist-led rehabilitation for patients with chronic musculoskeletal pain: interventions and promising long-term outcomes.Trulsson Schouenborg, A., Rivano Fischer, M., Bondesson, E., et al.[2021]
A new pain self-management intervention framework was developed specifically for people with spinal cord injury (PWSCI), consisting of 56 interventions that cover medical, psychological, therapeutic, and social approaches.
This framework, created through a consensus of 21 experts using a modified e-Delphi method, aims to guide both PWSCI and healthcare professionals in selecting appropriate pain management strategies based on the biopsychosocial model.
Development of a pain self-management intervention framework for people with spinal cord injury.Mashola, MK., Korkie, E., Mothabeng, DJ.[2023]
In a study of 1614 patients with chronic low-back pain (CLBP) and chronic neck pain (CNP) receiving ongoing chiropractic care, only about one-third aimed for a complete cure, while most focused on pain management goals like preventing recurrence or temporary relief.
The findings suggest that health policies should consider the predominant treatment goals of pain management among these patients, as many prioritize ongoing care rather than a definitive cure, which could influence how nonpharmacologic pain treatments are structured and funded.
Prevalence and Characteristics of Chronic Spinal Pain Patients with Different Hopes (Treatment Goals) for Ongoing Chiropractic Care.Herman, PM., Edgington, SE., Ryan, GW., et al.[2020]

Citations

Physiotherapist-led rehabilitation for patients with chronic musculoskeletal pain: interventions and promising long-term outcomes. [2021]
Development of a pain self-management intervention framework for people with spinal cord injury. [2023]
Prevalence and Characteristics of Chronic Spinal Pain Patients with Different Hopes (Treatment Goals) for Ongoing Chiropractic Care. [2020]
Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain. [2021]
Health Care Systems Support to Enhance Patient-Centered Care: Lessons from a Primary Care-Based Chronic Pain Management Initiative. [2019]
Clinical trials in acute musculoskeletal injury states. An analysis of methodology. [2019]
[Pain relief in sports injuries--emergency measures yield good results]. [2011]
Pitch-side Acute Severe Pain Management Decisions in European Elite Football. [2022]
Acute and chronic pain management in sport medicine: an expert opinion looking at an alternative mechanism-based approach to the pharmacological treatment. [2023]
International Olympic Committee consensus statement on pain management in elite athletes. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Nonpharmacological Management of Persistent Pain in Elite Athletes: Rationale and Recommendations. [2019]
Pain in elite athletes-neurophysiological, biomechanical and psychosocial considerations: a narrative review. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Quality assessment of athletic trainers. [2017]
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