Diagnostic Ultrasound for Patellofemoral Pain Syndrome

(POCUS Trial)

Overseen By Matthew Campbell, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Youngstown State University

Disqualifiers: Non-female, Non-athlete, Non-jump activities, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of point-of-care diagnostic ultrasound in assessing patellar tendon issues. It focuses on female student-athletes experiencing knee pain from jumping sports. Female collegiate athletes aged 18-25 who frequently jump in their sport may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance injury diagnosis for athletes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that point-of-care diagnostic ultrasound is safe for assessing patellar tendon pathologies?

Research shows that using ultrasound at the point of care safely checks knee pain, including patellofemoral pain syndrome. Clinicians have successfully used it to examine, diagnose, and even help treat conditions like patellar tendinopathy, which affects the knee tendons. Studies have not found any harmful effects from using ultrasound for these assessments.

Ultrasound is non-invasive, meaning it doesn't involve surgery or breaking the skin, so people generally tolerate it well. It provides a way to look inside the body without using radiation, unlike X-rays, making it safer for repeated use. Evidence supports it as a safe option for examining knee problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using point-of-care diagnostic ultrasound for patellofemoral pain syndrome because it offers a real-time, non-invasive way to assess knee issues right where the patient is being treated. Unlike traditional methods like MRI or X-rays, which can be time-consuming and costly, this ultrasound technique is quick and accessible, providing immediate insights. This could lead to faster and more accurate diagnoses, potentially improving treatment plans for athletes, especially jumping collegiate athletes, who experience this type of knee pain.

What evidence suggests that point-of-care diagnostic ultrasound is effective for assessing patellar tendon pathologies?

Research has shown that Point-of-Care Ultrasound (PoCUS) effectively diagnoses various muscle and bone issues, such as fractures and tendon injuries. Studies indicate it is particularly useful for assessing the patellar tendon, often associated with knee pain known as patellofemoral pain syndrome. PoCUS has correctly identified knee issues more than 70% of the time, demonstrating its accuracy in spotting knee problems. By providing quick and reliable results, PoCUS aids in evaluating and treating knee pain, especially in athletes. This trial will include female jumping collegiate athletes, who will be evaluated using PoCUS to assess its effectiveness in diagnosing patellofemoral pain syndrome. ^{1 2 6 7 8}

Who Is on the Research Team?

Morgan C Bagley, PhD

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

This trial is for female student-athletes aged 18 to 25 who are involved in sports with a lot of jumping. It's designed to help those experiencing knee pain, specifically around the kneecap.

Inclusion Criteria

I am a female student-athlete, aged 18-25, involved in sports that require jumping.

Exclusion Criteria

I am not an 18-25 year old female student-athlete in jump-centric sports.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diagnostic Assessment

Participants undergo diagnostic ultrasound examination of both patellar tendons using the Butterfly IQ device

1 day

1 visit (in-person)

Outcome Assessment

Participants complete the KOOS and KOOS-PF assessments following the ultrasound examination

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in patellar tendons and knee injury outcomes over a 2-year period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Point-of-Care Diagnostic Ultrasound

Trial Overview The study is testing the use of point-of-care ultrasound (POCUS) as an effective tool for diagnosing patellar tendon issues in athletes with knee pain.

How Is the Trial Designed?

Group I: Jumping Experimental Treatment 1 Intervention

Female jumping collegiate athletes

Point-of-Care Diagnostic Ultrasound is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as POCUS for:

• Trauma assessment
• Emergency care
• Critical care
• Musculoskeletal diagnostics

Approved in United States as POCUS for:

• Emergency care
• Critical care
• Musculoskeletal diagnostics
• Pediatric and neonatal intensive care

Approved in Canada as POCUS for:

• Emergency care
• Critical care
• Musculoskeletal diagnostics

Who Is Running the Clinical Trial?

Youngstown State University

Lead Sponsor

Trials

27

Recruited

2,000+

Published Research Related to This Trial

The introduction of Point-of-care ultrasound (POCUS) significantly reduced hospital referrals for injections by 92.6%, indicating its effectiveness in managing musculoskeletal issues in outpatient settings.

POCUS also increased the number of injections performed during consultations by 34.9%, demonstrating its utility in enhancing treatment delivery without the need for hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CLINICAL AND HEALTHCARE IMPACTS OF PORTABLE ULTRASONOGRAPHY IN AMBULATORY CARE MUSCULOSKELETAL REHABILITATION CONSULTATIONS. DE LA Lama, JM., Morales, M., DE Nicolas, J., et al.[2023]

This study is a randomized controlled trial involving 250 patients to assess the impact of point-of-care ultrasound (POCUS) on hospital length of stay for patients with cardiopulmonary diagnoses, aiming to fill the evidence gap regarding its clinical utility.

The trial will also evaluate secondary outcomes such as changes in diagnosis and management, 30-day hospital readmission rates, and healthcare costs, providing a comprehensive view of POCUS's effectiveness in internal medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial-the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study. Cid, X., Canty, D., Royse, A., et al.[2020]

In a one-day study across 50 emergency departments, point-of-care ultrasound (POCUS) was used in only 5% of patients, but when utilized, it had a significant impact on clinical practices, with 82% of cases confirming or changing the initial diagnosis.

POCUS also influenced treatment decisions in 47% of cases and confirmed or altered patient orientation in 85% of instances, demonstrating its high clinical value with a 95% rate of impacting diagnostic or imaging practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical impact and prevalence of emergency point-of-care ultrasound: A prospective multicenter study. Bobbia, X., Zieleskiewicz, L., Pradeilles, C., et al.[2018]

Point-of-care ultrasound (POCUS) enhances the accuracy of diagnoses made by clinicians at the bedside, improving both sensitivity and specificity for conditions like abdominal aortic aneurysms and kidney stones.

POCUS is particularly beneficial in outpatient clinics and emergency settings, where it can provide rapid diagnostic information and aid in patient triage, potentially reducing delays in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Point-of-Care Ultrasound for Family Medicine Physicians for Abdominopelvic and Soft Tissue Assessment. Frasure, SE., Dearing, E., Burke, M., et al.[2020]

A case-based course on Point-of-Care Ultrasound (POCUS) was developed for internal medicine residents and attendings at Shaare Zedek Medical Centre, covering essential topics like trauma assessment and ultrasound-guided procedures.

POCUS is expected to enhance rapid diagnosis, reduce complications from bedside procedures, and ultimately improve overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[WHEN ULTRASOUND MEETS THE INTERNIST]. Katz, D., Dadon, Z., Zalut, T., et al.[2018]

Emergency physician-performed point-of-care ultrasound (POCUS) demonstrated high sensitivity (90.2%) and specificity (96.1%) for detecting long bone fractures in a study of 106 patients, indicating it is a reliable diagnostic tool.

The study found that POCUS can effectively exclude long bone fractures, providing emergency physicians with a high degree of confidence in their evaluations before standard radiography is performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of point-of-care ultrasound to diagnose long bone fractures in the ED. Waterbrook, AL., Adhikari, S., Stolz, U., et al.[2022]

Point-of-care ultrasound (PoCUS) demonstrated good diagnostic value for detecting clinically significant ankle and fifth metatarsal fractures, with a sensitivity of 80.0% and specificity of 90.3% in a study of 242 patients.

The expert sonographer achieved even higher sensitivity (82.8%) and specificity (99.2%), indicating that experience with PoCUS can enhance its effectiveness compared to standard radiographic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care bedside ultrasound examination for the exclusion of clinically significant ankle and fifth metatarsal bone fractures; a single blinded prospective diagnostic cohort study. Crombach, A., Azizi, N., Lameijer, H., et al.[2021]

Point-of-care ultrasound (POCUS) is highly effective in diagnosing patella fractures, showing 95% sensitivity, which aids in early evaluation and management of knee injuries.

In this case, a 49-year-old woman with a fractured patella was successfully treated with surgery after ultrasound confirmed the diagnosis, leading to a full return to function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patella Fracture Identified Using Point-of-care Ultrasound. Richman, M., Kieffer, A., Moss, R., et al.[2021]

Point of Care Ultrasound (PoCUS) is a portable and innovative tool that allows clinicians to quickly diagnose orthopedic emergencies, such as occult fractures, joint effusions, and tendon ruptures, directly at the patient's bedside.

The use of PoCUS can lead to faster diagnoses, which helps reduce unnecessary immobilization and hospital stays, promoting early mobilization and improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Point of Care Ultrasound (PoCUS) in Orthopaedic Emergency Diagnostics. Oluku, J., Stagl, A., Cheema, KS., et al.[2021]

The point-of-care ultrasound DVT (POCUS DVT) examination allows for quick diagnosis and treatment of lower extremity deep vein thrombosis (DVT) at the bedside, which can significantly reduce delays in administering lifesaving anticoagulation.

This article provides guidance on accepted techniques for performing POCUS DVT, highlights the evolution of current recommendations, and addresses common pitfalls to improve diagnostic accuracy for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Ultrasound for Bedside Diagnosis of Lower Extremity DVT. Barrosse-Antle, ME., Patel, KH., Kramer, JA., et al.[2022]

Point-of-care musculoskeletal ultrasound is effective in identifying joint effusions and assessing their quality, which can aid in diagnosing conditions like juvenile idiopathic arthritis (JIA).

In a case involving a previously healthy pediatric patient with knee swelling, ultrasound revealed complex effusions, leading to the diagnosis of JIA, highlighting the utility of this imaging technique in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneous Knee Effusions on Point-of-Care Ultrasound in a Toddler Diagnosed With Juvenile Idiopathic Arthritis. Rizvi, MB., Rabiner, JE.[2018]

Citations

1. withpower.com withpower.com/trial/phase-patellofemoral-disorder-1-2023-e5750

Diagnostic Ultrasound for Patellofemoral Pain Syndrome ... Research shows that Point-of-Care Ultrasound (PoCUS) is effective in quickly diagnosing various musculoskeletal issues, such as fractures and tendon injuries, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357834/

Sonographic assessment of patellofemoral pain syndrome Our study suggests that the modified PT, modified QT, and lateral retinaculum thicknesses each have sensitivity and specificity greater than 70% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468781222000297

Clinicians' experience of the diagnosis and management ... Patellofemoral pain (PFP) is common and has a poor long-term prognosis. There is a lack of clarity about the clinical reasoning of recognised inter-disciplinary ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/10669817.2025.2470460?src=

Point of care ultrasonography in physical therapists' clinical ... This paper offers a contemporary, evidence-based perspective on how point of care ultrasonography imaging (POCUS) has the potential to impact orthopedic and ...

5. lermagazine.com lermagazine.com/article/point-of-care-diagnostic-ultrasound-in-the-evaluation-of-patients-with-patellar-tendinopathy

Point of Care Diagnostic Ultrasound in the Evaluation ... Point of care diagnostic ultrasound can be a useful tool for the evaluation, diagnosis, treatment, and risk identification of patellar tendinopathy.

6. researchgate.net researchgate.net/publication/389232274_Use_of_Diagnostic_Point_of_Care_Ultrasound_and_Therapeutic_Interventions_for_Knee_Pain_in_a_Female_Collegiate_Volleyball_Player_Level_3_Exploration_Clinical_Case_Series_Report

Level 3: Exploration Clinical Case Series Report The results show that the patellar tendon may be only the zone of perceived pain and that interesting results can be obtained by treating ...

7. mdpi.com mdpi.com/2075-4418/13/8/1496

Patello-Femoral Pain Syndrome: Magnetic Resonance ... MRI and Ultrasound examination in combination with clinical data demonstrated high-value results in the diagnosis of PFS.

8. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-020-00914-2

Diagnostic accuracy of ultrasonography in the assessment ... The ultrasonography provided the highest sensitivity (100%) in detecting bipartite patella, followed by 91.5% for joint effusion, and 87.5% for ...