SWE + MFI Imaging for Athletic Injuries

Recruiting at 1 trial location

Overseen By Natalie Pettigrew, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Prior fasciotomy, Hemodialysis grafts, Wounds

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

9 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Shear Wave Elastography and Microvascular Flow Imaging for athletic injuries?

Shear Wave Elastography (SWE) is used to measure tissue stiffness, which can help in understanding changes in muscles and tendons after exercise, as seen in studies with athletes. This suggests that SWE could be useful in monitoring and managing athletic injuries by providing insights into tissue condition and recovery. ^{1 2 3 4 5}

Is Shear Wave Elastography (SWE) safe for use in humans?

Shear Wave Elastography (SWE) is a non-invasive imaging technique used to assess muscle and tendon stiffness, and studies have shown it to be safe for use in humans, with no reported adverse effects. ^{3 6 7 8 9}

How does the SWE + MFI Imaging treatment for athletic injuries differ from other treatments?

The SWE + MFI Imaging treatment is unique because it uses advanced imaging techniques to assess the mechanical properties of muscles and tendons in three dimensions, providing more precise and reproducible measurements compared to traditional two-dimensional methods. This approach allows for better detection of tissue changes and adaptations, which can be crucial for diagnosing and monitoring athletic injuries. ^{6 10 11 12 13}

What is the purpose of this trial?

Primary Objective: To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment. Secondary Objective: To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI. Methodology: Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements. Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.

Research Team

Kenton Gregory, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for adults aged 18-89 with suspected musculoskeletal injuries of the lower extremity, like hamstring or ankle soft tissue injuries. Participants must be able to consent. It's not for those who've had a fasciotomy on the same limb, have hemodialysis grafts in that extremity, or wounds preventing ultrasound imaging.

Inclusion Criteria

Able to sign an informed consent document

I suspect I have a muscle or soft tissue injury in my leg or ankle.

Exclusion Criteria

I have a hemodialysis graft in my arm or leg.

I have had a fasciotomy on the same limb before.

You have wounds on your arms or legs that make it difficult to do an ultrasound.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit

24 weeks

Regular visits throughout rehabilitation

Follow-up

Participants are monitored for changes in tissue stiffness and blood flow post-treatment

4 weeks

Treatment Details

Interventions

• Shear Wave Elastography and Microvascular Flow Imaging

Trial Overview The study tests how shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements change from injury through recovery in lower extremity injuries. It aims to correlate these changes with functional impairment and develop an AI system for automated measurement.

Participant Groups

Group I: Musculoskeletal injury Experimental Treatment 1 Intervention

Shear wave elastography and microvascular flow imaging.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Effects of Running on Shear Wave Elastography Measures of the Achilles Tendon and Calf Muscles in Professional Female Handball and Volleyball Players. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Achilles tendon (TA) size and power Doppler ultrasound (PD) changes compared to MRI: a preliminary observational study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Healing Process of Gastrocnemius Muscle Injury on Ultrasonography Using B-Mode Imaging, Power Doppler Imaging, and Shear Wave Elastography. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Shear wave elastography assessment and comparison study of the Achilles tendons in optimally conditioned asymptomatic young collegiate athletes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Intra-rater reliability and smallest detectable change of compression sonoelastography in quantifying the material properties of the musculoskeletal system. [2022]

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

Shear wave elastography of the supraspinatus muscle and tendon: Repeatability and preliminary findings. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Muscle and Tendon Stiffness of the Lower Limb of Professional Adolescent Soccer Athletes Measured Using Shear Wave Elastography. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Limitations of Muscle Ultrasound Shear Wave Elastography for Clinical Routine-Positioning and Muscle Selection. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Stiffness of Muscles and Tendons of the Lower Limb of Professional and Semiprofessional Athletes Using Shear Wave Elastography. [2022]

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

Shear-Wave Elastography: Basic Physics and Musculoskeletal Applications. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Reproducibility of shear wave elastography measuresof the Achilles tendon. [2018]

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

Repeatability of Rotational 3-D Shear Wave Elasticity Imaging Measurements in Skeletal Muscle. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Three-Dimensional Mapping of Shear Wave Velocity in Human Tendon: A Proof of Concept Study. [2021]