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?

The purpose of this study is to utilize Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons to understand the functional differences between normal/asymptomatic and symptomatic tendon states. The study will also assess the degree of tendon healing following standard of care treatment.

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 safety data exists for PRP treatment in tendinopathy?

The safety of platelet-rich plasma (PRP) treatment for tendinopathy has been evaluated in several studies. These studies generally focus on the efficacy and potential complications of PRP injections, often guided by ultrasound. The research includes systematic reviews and meta-analyses, as well as pilot studies with long-term follow-up, which suggest that PRP is a promising treatment for tendinopathy with a focus on pain reduction and functional improvement. However, the progress in determining its efficacy and safety has been slow, and treatment complications are discussed in the context of concurrent therapies and platelet activation. Overall, PRP is considered a relatively safe treatment option, but further research is needed to fully understand its safety profile. ^{1 2 3 4 5}

Is Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma (PRP) a promising treatment for tendinopathy?

Yes, Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma (PRP) is a promising treatment for tendinopathy. Studies show that it can help reduce pain and improve function in people with chronic tendinopathy by promoting healing and increasing collagen production, which is important for tendon repair. ^{1 2 3 6 7}

What data supports the idea that Shear Wave Elastography for Tendinopathy is an effective treatment?

The available research shows that using platelet-rich plasma (PRP) injections, guided by ultrasound, can be effective in treating tendinopathy. Studies have demonstrated that PRP can help reduce pain and improve function in patients with chronic tendinopathy. For example, one study found that PRP injections led to pain reduction and functional improvement in patients with chronic tendinopathy. Another study highlighted that PRP can stimulate cell growth and collagen production, which are important for healing. Additionally, a systematic review and meta-analysis confirmed the effectiveness of PRP injections as a conservative treatment for tendinopathies. These findings suggest that PRP injections, when guided by ultrasound, can be a beneficial treatment option for tendinopathy. ^{1 2 3 5 8}

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

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 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]

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]

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]

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]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis. [2023]

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

Intratendinous injection of platelet-rich plasma under US guidance to treat tendinopathy: a long-term pilot study. [2016]

3. Italy pubmed.ncbi.nlm.nih.gov

Ultrasound-guided injection of platelet-rich plasma in chronic Achilles and patellar tendinopathy. [2021]

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

Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. [2022]

5. France 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. [2022]

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

Equine Platelet-Rich Plasma. [2023]

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

Reliability of shear wave elastography ultrasound to assess the supraspinatus tendon: An intra and inter-rater in vivo study. [2022]

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

Increasing platelet concentrations in leukocyte-reduced platelet-rich plasma decrease collagen gene synthesis in tendons. [2018]