Shear Wave Elastography for Tendinopathy

Overseen By David Reiter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Corticosteroids, Estrogens, Quinolones, Cholesterol drugs

Disqualifiers: Pregnancy, Tendinopathy, Surgery, Systemic diseases, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for examining tendons using Shear Wave Elastography (SWE), which helps differentiate between healthy and painful tendons. The study focuses on tendons affected by tendinopathy, a condition where tendons become inflamed or irritated. Researchers will assess tendon healing after standard treatment with ultrasound-guided Percutaneous Tenotomy (a needle procedure) combined with Platelet-Rich Plasma (a blood component that promotes healing). Suitable candidates for this trial include individuals diagnosed with tendinopathy confirmed by ultrasound or those experiencing lower extremity pain without tendon issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance tendon treatment options.

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

The trial does not specify if you need to stop your current medications, but you cannot participate if you have a history of treatment with corticosteroids, estrogens, long-term quinolone antibiotics, or cholesterol drugs.

What prior data suggests that Shear Wave Elastography is safe for studying tendons?

Research has shown that using ultrasound to guide a needle procedure, followed by a platelet-rich plasma (PRP) injection, is generally safe for treating tendon problems. One study found this method to be safe and effective for long-term tendon issues, with no serious side effects reported. Another study confirmed these positive safety results.

Participants in these studies typically did not experience severe side effects, and the treatment was well-tolerated. Some individuals felt mild discomfort or pain at the injection site, but these effects were temporary. Overall, evidence suggests that this treatment is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Shear Wave Elastography for tendinopathy because it offers a new way to visualize and assess tendon health. Unlike traditional imaging methods, this technique uses sound waves to measure the stiffness of tendons, providing real-time, detailed insights into the condition of the tissue. This can help clinicians better understand the healing process and adjust treatments more precisely. Additionally, it has the potential to identify issues earlier than other methods, potentially leading to more effective interventions.

What evidence suggests that Shear Wave Elastography is effective for studying tendinopathy?

Research has shown that ultrasound-guided percutaneous tenotomy followed by an injection of platelet-rich plasma (PRP) effectively treats long-lasting tendon problems. This trial will evaluate this method, which studies have found safe and beneficial for individuals who haven't improved with other treatments. Another arm of the trial will focus on PRP alone, which reviews suggest can lessen pain and improve movement for conditions like tennis elbow and shoulder injuries. PRP has demonstrated better long-term results compared to steroid injections, which are often used for similar issues. Overall, both the needle procedure with PRP and PRP alone appear promising for reducing pain and aiding recovery in tendon problems. ^{6 7 8 9 10}

Who Is on the Research Team?

David Reiter, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals with a confirmed diagnosis of tendinopathy using ultrasound. It includes those experiencing lower extremity pain without tendon involvement and patients diagnosed clinically with tenalgia, which is pain in the tendons.

Inclusion Criteria

You have been diagnosed with tendon injury using ultrasound.

You have pain in your lower legs, but not in the tendons.

You have been diagnosed with tendon pain and are seeking treatment at the study location.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Shear wave elastography imaging is used to establish baseline measurements of viscoelastic properties of tendons among asymptomatic and symptomatic patients.

1 week

1 visit (in-person)

Treatment and Monitoring

Participants receive standard of care treatment and are monitored for changes in tendon healing using shear wave imaging and various assessment scales.

12 months

Multiple visits (in-person) at Month 3, Month 6, Month 9, and Month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-Rich Plasma Injection
• Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma (PRP)

Trial Overview The study uses Shear Wave Elastography (SWE) to examine the viscoelastic properties of tendons. The goal is to understand how normal and symptomatic tendons differ functionally and to evaluate tendon healing after standard treatments.

How Is the Trial Designed?

Group I: Shear Wave Elastography for Asymptomatic Volunteers Experimental Treatment 1 Intervention

Patients with extremity pain but without tendon involvement will have tendon imagining using shear wave elastography.

Group II: Shear Wave Elastography Symptomatic Volunteers Experimental Treatment 1 Intervention

Patients diagnosed with tendinopathy will have tendon imagining using shear wave elastography. Participants may have the option to have repeated imaging to examine tendon healing for up to a year after receiving standard of care treatment.

Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma (PRP) is already approved in United States, European Union for the following indications:

Approved in United States as Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma for:

• Chronic tendinopathy
• Tendinosis

Approved in European Union as Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma for:

• Chronic tendinopathy
• Tendinosis

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Shear wave elastography ultrasound effectively differentiates between normal and tendinopathic supraspinatus tendons, showing that tendinopathic tendons are less stiff, with significant differences in shear wave velocity (9.96 m/s for normal vs. 8.3 m/s for tendinopathic).

The technique demonstrated excellent intra-rater reliability (intraclass correlation coefficient of 0.96) when performed by an experienced sonographer, although inter-rater reliability was lower (0.45), indicating that consistency improves with experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of shear wave elastography ultrasound to assess the supraspinatus tendon: An intra and inter-rater in vivo study. Hackett, L., Aveledo, R., Lam, PH., et al.[2022]

In a study involving 8 horses, it was found that while increasing platelet concentrations in leukocyte-reduced PRP (lrPRP) led to higher levels of anabolic growth factors, it also resulted in decreased synthesis of important tendon proteins (COL1A1 and COL3A1), indicating a potential plateau effect in efficacy.

The research suggests that minimizing leukocyte content in PRP is more crucial for reducing inflammation and enhancing tendon healing than simply maximizing platelet numbers, highlighting the need for optimal PRP formulations in treating tendinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing platelet concentrations in leukocyte-reduced platelet-rich plasma decrease collagen gene synthesis in tendons. Boswell, SG., Schnabel, LV., Mohammed, HO., et al.[2018]

Platelet-rich plasma (PRP) therapy, which has been used for 20 years, shows potential for treating tendon, ligament, and joint diseases, although determining its efficacy has been challenging due to varying definitions and classifications.

Recent advancements include the development of PRP lysates optimized for antibiofilm and antimicrobial properties, suggesting a promising direction for enhancing the therapeutic effects of PRP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine Platelet-Rich Plasma. McCarrel, TM.[2023]

A study involving 51 patients with chronic tendinopathy showed that ultrasound-guided percutaneous needle tenotomy followed by a platelet-rich plasma (PRP) injection resulted in significant pain reduction (58% improvement) and functional improvement (68% improvement) after a mean follow-up of 14 months.

While no tendons appeared normal on ultrasound after treatment, 84% of patients showed improved tendon echotexture, 64% had resolution of calcifications, and 82% experienced decreased neovascularity, indicating structural improvements in the tendons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. Finnoff, JT., Fowler, SP., Lai, JK., et al.[2022]

In a systematic review of 33 randomized controlled trials involving 2,025 subjects, ultrasound-guided injections of platelet-rich plasma (PRP) showed no significant differences in pain and functional outcomes compared to various control treatments for most types of tendinopathies.

However, PRP injections did result in significantly lower pain scores in patients with carpal tunnel syndrome at 3 and 6 months, although the overall evidence quality was low due to potential biases and inconsistencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis. Masiello, F., Pati, I., Veropalumbo, E., et al.[2023]

In a study of 408 patients, intratendinous injection of platelet-rich plasma (PRP) under ultrasound guidance significantly improved tendon healing, as shown by reduced QuickDASH and WOMAC scores and smaller lesion sizes at 6 weeks and up to 32 months post-treatment.

The procedure was well tolerated with no reported clinical complications, indicating it is a safe option for treating tendon tears and tendinosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratendinous injection of platelet-rich plasma under US guidance to treat tendinopathy: a long-term pilot study. Dallaudière, B., Pesquer, L., Meyer, P., et al.[2016]

In a study involving 48 patients with patellar and Achilles tendinopathy, ultrasound-guided injections of platelet-rich plasma (PRP) led to a significant improvement in clinical symptoms after 6 months, with VISA scores increasing from 57 to 75.5 (p < 0.01).

Ultrasound evaluations showed a reduction in hypoechoic areas and improved tendon structure, indicating that PRP treatment not only alleviates pain but also promotes healing and recovery of the tendon matrix.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided injection of platelet-rich plasma in chronic Achilles and patellar tendinopathy. Ferrero, G., Fabbro, E., Orlandi, D., et al.[2021]

A second intra-tendinous injection of platelet-rich plasma (PRP) did not significantly reduce the size of tendon lesions or improve clinical pain and function in the short term after an initial PRP treatment, based on a study of 24 patients with tendon tears or tendinosis.

Despite the lack of immediate improvement after the second injection, patients showed significant long-term functional improvement in their ability to mobilize affected tendons, indicating that PRP may still contribute to healing over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of second intra-tendinous platelet-rich-plasma injection in case of incomplete response of the first injection: three-year follow up experience. Dallaudière, B., Meyer, P., Hummel, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6339617/

The Efficacy of Platelet-Rich Plasma on Tendon and Ligament ... This review shows that PRP may reduce the pain associated with lateral epicondylitis and rotator cuff pathology.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11350620/

Mechanisms, Efficacy, and Clinical Applications of Platelet ... Research published in the Journal of Hand Surgery has reported superior outcomes with PRP injections compared to corticosteroid injections in ...

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08566-3

Platelet-rich plasma and corticosteroid injection for tendinopathy PRP can effectively improve pain and functional impairment in patients with tendinopathy, and its mid-term efficacy is superior to that of corticosteroids.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2059775421000778

Platelet-rich plasma in orthopaedic sports medicine The current review explores the latest findings on PRP efficacy in several musculoskeletal conditions, focusing on results of the highest level of evidence ...

5. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/143581-comparative-efficacy-of-platelet-rich-plasma-and-corticosteroid-injections-for-rotator-cuff-injury-management-a-systematic-review-and-meta-analysis

Comparative Efficacy of Platelet-Rich Plasma and ... This study aims to compare the efficacy and safety of PRP versus corticosteroid injections in patients with rotator cuff tendinopathy or partial ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33644963/

Ultrasound-guided percutaneous needle tenotomy (PNT) ... Although pain scores were lower after PNT compared to PNT + LR-PRP at 6 weeks, there were no between-group differences in outcomes at 52 or ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148211003637

Treatment of Chronic Tendinopathy with Ultrasound ... In this case series, we found US-guided percutaneous needle tenotomy followed by PRP injection to be a safe and effective treatment for chronic, recalcitrant ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04299802

Percutaneous Ultrasonic Tenotomy Versus Platelet Rich ... The primary objective of this study is to evaluate safety and effectiveness of both a single percutaneous ultrasonic tenotomy or a single injection of LR-PRP ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21872551/

Treatment of Chronic Tendinopathy With Ultrasound ... We found US-guided percutaneous needle tenotomy followed by PRP injection to be a safe and effective treatment for chronic, recalcitrant tendinopathy.

10. asipp.org asipp.org/wp-content/uploads/Ultrasound%E2%80%90guided-percutaneous-needle-tenotomy-PNT-alone-versus-PNT-plus-platelet%E2%80%90rich-plasma-2021-PMR.pdf

Ultrasound‐guided percutaneous needle tenotomy (PNT) ... Inclusion criteria included age 18 to 100 years, findings consistent with chronic tendinosis confirmed clinically and with ultrasound, a numerical rating scale ...