Sports Medicine InjuriesNCT05821699
Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries
A study testing LCS (Life Care Specialist) in people with Sports Medicine Injuries, run by Emory University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Sports Medicine Injuries
- What is being tested?
- LCS (Life Care Specialist)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2023to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
Official title: Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes
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.
Read the 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
- Being tested
- LCS (Life Care Specialist), Standard of Care
- Keywords
- Personalized Pain Coach, Postoperative outcome, Life Care Specialist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCS (Life Care Specialist)Behavioural
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
Standard of CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| In Person LCS Intervention- With Opioid Risk Education | Experimental | 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. Receives: Behavioral: LCS (Life Care Specialist) |
| Virtual LCS Intervention-With Opioid Risk Education | Experimental | 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 Receives: Behavioral: LCS (Life Care Specialist) |
| No LCS intervention | Active comparator | 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. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale (NRS)
The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable". The NRS is a commonly used pain assessment tool in both clinical practice and research. However, the NRS is a single static measure of pain and does not capture the biopsychosocial presentations of pain including physical functioning. Inpatient NRS, which is recorded by the clinical care team throughout each day, will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital
Measured: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Opioid Utilization
Baseline (intraoperative and Post-Anesthesia Care Unit (PACU)) opioid utilization will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital. Opioid medication dosage will be transformed to morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day. Additionally, the study team will review participants' EHR at each study time point up to 3-months to determine MME throughout postoperative recovery and rehabilitation, and review medication in the MEMS cap.
Measured: Baseline (Intraoperative and PACU) and 3 months post-surgery
Secondary outcomes (7)
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)
The PROMIS Sleep Disturbance (PROMIS-SD) scale measures self-reported sleep quality, depth, and restoration over the past 7 days. Respondents report their capabilities to perform each task or symptom burden on a Likert scale from 5, "very much", to 1, "never". , with higher scores (T-scores) indicating greater, more severe disturbances. The raw scores of all items are summed before being transformed into t-scores, which range from 0 to 100. A T-score of 50 represents the average with a standard deviation of 10; lower scores indicate better sleep, while scores >=60 indicate mild-to-severe disruption, with higher scores signifying worse sleep.
Measured: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS- Physical Function (PF)
This PROMIS PF scale measures self-reported capabilities. Respondents report their capabilities to perform each task or symptom burden on a Likert scale from 5, "without any difficulty", to 1, "unable to do". The raw scores of all items are summed before being transformed into t-scores. A T-score of 50 represents the average with a standard deviation of 10. Higher T-scores indicate better functioning, while scores below 50 reflect limitations.
Measured: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS - Pain Interference
Self-reported pain interference with activities is assessed with the PROMIS Pain Interference - Short Form. Responses to the 4 items are given on a 5-point Likert scale from 1 to 5, no interference to much interference. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and standard deviation of 10. Scores above 50 indicate worse pain interference than the average person.
Measured: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS - Global Health Scale
The PROMIS Global Health scale is a 10-item patient-reported survey evaluating overall physical and mental health. It produces two standardized T-scores (Physical/Mental), with a mean of 50 and a standard deviation (SD) of 10, where higher scores indicate better health. Scores <=55 are generally considered within normal limits, while scores below 40-45 indicate significant impairment.
Measured: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS Prescription Misuse Scores
The PROMIS Prescription Pain Medication Misuse (PROMIS-Rx Misuse) is a 22-item, patient-reported tool designed to assess the frequency and severity of prescription opioid abuse over the past three months. The 22-item bank uses a 5-point frequency scale (Never, Rarely, Sometimes, Often, Almost Always). Scores are scaled to a mean of 50 and a standard deviation of 10. A T-score of 60 indicates one SD above the average (higher risk), while 40 is one SD below. The scale does not have an officially established, clinically validated "cut-off" score for diagnosing misuse or addiction. Higher scores in this domain are often positively associated with pain intensity, depressive symptoms, and opioid-related side effects such as mental slowness or drowsiness.
Measured: 1 month pre-surgery and 3 months post-surgery
Mindful Attention Awareness Scale (MAAS)
The MAAS is a validated 15-item scale designed to assess a core characteristic of dispositional mindfulness, specifically open or receptive awareness of and attention to what is happening in the present. Each item is rated on a 6-point Likert scale (1 = Almost Always, 6 = Almost Never). The mean or total score is calculated, with higher scores indicating greater mindfulness (i.e., more awareness and attention to the present moment), and lower scores indicating more automatic or distracted behavior.
Measured: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Actigraphy Based Sleep Data
Study participants will be given a wrist actigraphy device during their hospitalization and recovery until their 2-week follow-up appointment with the surgical team or until the watch battery loses its charge, whichever occurs first.
Measured: 1 month pre-surgery, 2 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start17 Aug 2023
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sports Medicine InjuriesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Football League
- Responsible party
- Principal investigator, Nicholas A. Giordano, Emory University
- Investigators
- Nicholas A Giordano, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821699
- Sponsor's protocol ID
- STUDY00004925
- Other IDs
- 2025P009229
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2023
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in articles, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT05821699
- Acronym / sponsor ID
- STUDY00004925
- Conditions
- Sports Medicine Injuries
- Keywords
- Personalized Pain Coach, Postoperative outcome, Life Care Specialist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Football League
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In Person LCS Intervention- With Opioid Risk Education | Experimental | Behavioral: LCS (Life Care Specialist)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. |
| Virtual LCS Intervention-With Opioid Risk Education | Experimental | Behavioral: LCS (Life Care Specialist)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 |
| No LCS intervention | Active comparator | Behavioral: Standard of CarePatients 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 may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | In Person LCS Intervention- With Opioid Risk Education, Virtual LCS Intervention-With Opioid Risk Education |
| Standard of CarePatients 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. | Behavioural | No LCS intervention |
Primary outcome
Pain Numerical Rating Scale (NRS)
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable". The NRS is a commonly used pain assessment tool in both clinical practice and research. However, the NRS is a single static measure of pain and does not capture the biopsychosocial presentations of pain including physical functioning. Inpatient NRS, which is recorded by the clinical care team throughout each day, will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital
Opioid Utilization
Time frame: Baseline (Intraoperative and PACU) and 3 months post-surgery
Baseline (intraoperative and Post-Anesthesia Care Unit (PACU)) opioid utilization will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital. Opioid medication dosage will be transformed to morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day. Additionally, the study team will review participants' EHR at each study time point up to 3-months to determine MME throughout postoperative recovery and rehabilitation, and review medication in the MEMS cap.
7 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS- Physical Function (PF)
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS - Pain Interference
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS - Global Health Scale
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS Prescription Misuse Scores
Time frame: 1 month pre-surgery and 3 months post-surgery
Mindful Attention Awareness Scale (MAAS)
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Actigraphy Based Sleep Data
Time frame: 1 month pre-surgery, 2 weeks post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in articles, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas A Giordano, PhD principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCS (Life Care Specialist) in people with Sports Medicine Injuries, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale (NRS) (time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.