150 Participants Needed

Shear Wave Elastography for Tendinopathy

FG
DR
Overseen ByDavid Reiter, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12367

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.12358

Who Is on the Research Team?

DR

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?
2Treatment groups
Experimental Treatment
Group I: Shear Wave Elastography for Asymptomatic VolunteersExperimental Treatment1 Intervention
Patients with extremity pain but without tendon involvement will have tendon imagining using shear wave elastography.
Group II: Shear Wave Elastography Symptomatic VolunteersExperimental Treatment1 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

Find a Clinic Near You

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

Citations

Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis. [2023]
Intratendinous injection of platelet-rich plasma under US guidance to treat tendinopathy: a long-term pilot study. [2016]
Ultrasound-guided injection of platelet-rich plasma in chronic Achilles and patellar tendinopathy. [2021]
Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. [2022]
Efficacy of second intra-tendinous platelet-rich-plasma injection in case of incomplete response of the first injection: three-year follow up experience. [2022]
Equine Platelet-Rich Plasma. [2023]
Reliability of shear wave elastography ultrasound to assess the supraspinatus tendon: An intra and inter-rater in vivo study. [2022]
Increasing platelet concentrations in leukocyte-reduced platelet-rich plasma decrease collagen gene synthesis in tendons. [2018]
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