Personalized Pain Coaching for Sports Injuries

Recruiting at 1 trial location

Overseen By Nicholas A Giordano, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Unemployed, Retired, Incarcerated, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

150 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 5 6 7 8}

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. ^{9 10 11 12 13}

Who Is on the Research Team?

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

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?

Group I: Virtual LCS Intervention-With Opioid Risk Education Experimental Treatment 1 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 Education Experimental Treatment 1 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 intervention Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 55 peer coaches for chronic pain, significant increases in anxiety and pain catastrophizing were observed at 6 months, although these changes were not significant after adjustments for multiple comparisons.

The findings suggest that while peer coaching is a promising model for managing chronic conditions, it is crucial to monitor the well-being of both coaches and those they support, as coaching may not automatically confer benefits to the coaches themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain. Matthias, MS., Daggy, J., Ofner, S., et al.[2021]

Engaging patients and primary care physicians in a pilot randomized controlled trial revealed that involving diverse stakeholders, including caregivers and IT staff, is crucial for improving patient-centered care in chronic pain management.

The study highlighted the need for thorough training and preparation for stakeholders, especially those without prior research experience, to ensure effective communication and implementation of patient-centered assessment processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Systems Support to Enhance Patient-Centered Care: Lessons from a Primary Care-Based Chronic Pain Management Initiative. Elder, CR., Debar, LL., Ritenbaugh, C., et al.[2019]

Effective evaluation of nonsteroidal anti-inflammatory drugs (NSAIDs) for treating acute musculoskeletal conditions requires well-designed clinical trial models that ensure adequate patient populations and proper protocols.

Using sports medicine models can enhance the reliability of these studies by providing sufficient patient numbers and relevant data, while also suggesting methods like global pain relief scores and home diaries to improve data collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials in acute musculoskeletal injury states. An analysis of methodology. Honig, S.[2019]

Athletes often seek medical help primarily due to pain, and while non-pharmacological treatments like compression, elevation, and cryotherapy can be beneficial, they also have specific limitations that need to be understood.

Using pain relief methods to mask injuries in sports is ethically questionable and practically challenging, as achieving sufficient pain relief can hinder athletic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain relief in sports injuries--emergency measures yield good results]. Andrén-Sandberg, A., Thorsson, O.[2011]

In a survey of 44 senior sports medicine doctors from 55 European countries, 75% reported not using consistent clinical practice guidelines for managing acute severe pain, indicating a lack of standardized approaches in this area.

Many doctors showed a tendency to undertreat pain, with concerns about using strong opioids due to monitoring challenges and anti-doping regulations, particularly in pediatric patients, where 34% would avoid strong opioids altogether.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pitch-side Acute Severe Pain Management Decisions in European Elite Football. Doheny, MC., Bury, G.[2022]

The rise in sports participation has led to increased instances of acute and chronic pain, which can stem from injuries, postural imbalances, or overuse, necessitating a comprehensive diagnostic and therapeutic approach.

New therapies like regenerative medicine and peripheral neuromodulation have shown effectiveness in not only reducing pain but also promoting healing, allowing athletes to return to their activities more quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and chronic pain management in sport medicine: an expert opinion looking at an alternative mechanism-based approach to the pharmacological treatment. Fanelli, A., Laddomada, T., Sacchelli, M., et al.[2023]

There are currently no established guidelines for managing pain in elite athletes, which is a significant issue since pain and injury can greatly affect their performance.

The IOC Consensus Group recommends a comprehensive treatment strategy that addresses not just the pain itself, but also underlying causes, biomechanical issues, and psychosocial factors, aiming for therapies that provide the best benefits with the least harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Olympic Committee consensus statement on pain management in elite athletes. Hainline, B., Derman, W., Vernec, A., et al.[2022]

Persistent pain is a common issue among elite athletes, and effective management requires a comprehensive understanding of pain science and a biopsychosocial approach that considers physical, psychological, and social factors.

Optimal pain management strategies include thorough assessments and targeted interventions such as education, adjustments in training, psychological therapies, and inflammation management to address the various contributing factors to pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological Management of Persistent Pain in Elite Athletes: Rationale and Recommendations. Moseley, GL., Baranoff, J., Rio, E., et al.[2019]

Pain is a prevalent issue for elite athletes, often linked to sports injuries, and can significantly hinder their performance.

Effective pain management should consider the unique physiological, anatomical, and psychosocial factors affecting each athlete, distinguishing it from traditional injury management that focuses solely on physical recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain in elite athletes-neurophysiological, biomechanical and psychosocial considerations: a narrative review. Hainline, B., Turner, JA., Caneiro, JP., et al.[2022]

A study of 30 certified athletic trainers at the 1985 Junior Olympic Games showed that they effectively managed 121 significant injuries, with 97% of athletes fully recovering within 9 months, highlighting the trainers' capability in injury assessment and management.

Despite a lack of communication with parents about injuries, both athletes and physicians expressed high satisfaction with the athletic trainers' performance, indicating the importance of athletic trainers in providing quality care during multisport events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assessment of athletic trainers. Foster, DT., Yesalis, CE., Ferguson, KJ., et al.[2017]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Physiotherapist-led rehabilitation for patients with chronic musculoskeletal pain: interventions and promising long-term outcomes. [2021]

2. South Africa pubmed.ncbi.nlm.nih.gov

Development of a pain self-management intervention framework for people with spinal cord injury. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Prevalence and Characteristics of Chronic Spinal Pain Patients with Different Hopes (Treatment Goals) for Ongoing Chiropractic Care. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Health Care Systems Support to Enhance Patient-Centered Care: Lessons from a Primary Care-Based Chronic Pain Management Initiative. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical trials in acute musculoskeletal injury states. An analysis of methodology. [2019]

7. Sweden pubmed.ncbi.nlm.nih.gov

[Pain relief in sports injuries--emergency measures yield good results]. [2011]

8. Germany pubmed.ncbi.nlm.nih.gov

Pitch-side Acute Severe Pain Management Decisions in European Elite Football. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Acute and chronic pain management in sport medicine: an expert opinion looking at an alternative mechanism-based approach to the pharmacological treatment. [2023]

10. England pubmed.ncbi.nlm.nih.gov

International Olympic Committee consensus statement on pain management in elite athletes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacological Management of Persistent Pain in Elite Athletes: Rationale and Recommendations. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Pain in elite athletes-neurophysiological, biomechanical and psychosocial considerations: a narrative review. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Quality assessment of athletic trainers. [2017]