Needle Tenotomy Techniques for Tendinopathy

DV
KV
Overseen ByKyle V Goerl, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a newer technique using an ultrasound needle is more effective than the traditional method with a regular needle for treating gluteal tendinosis, a condition causing pain and limited movement in the hip area. The trial examines whether either technique reduces pain and improves function, and if one is superior. Individuals with gluteal tendinosis symptoms lasting more than three months, who haven't improved with other treatments, might be suitable for this study. As an unphased trial, it offers patients the chance to explore innovative treatment options that could potentially enhance their quality of life.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these tenotomy techniques are safe for treating gluteal tendinosis?

A previous study found both Percutaneous Ultrasonic Needle Tenotomy (PUT) and Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) to be safe and effective treatment options. These methods are minimally invasive, involving only small cuts or sometimes none at all.

For PNT, research has shown that patients did not experience complications, and the treatment provided significant pain relief, indicating that PNT is generally well-tolerated.

For PUT, the evidence is less clear. Some reports show good results, but there isn't enough solid data to fully confirm its safety. However, it has been successfully used in some cases, such as treating tendon problems in the heel.

In summary, both treatments are generally considered safe, with PNT having more clear safety data. PUT shows promise, but more research is needed to fully confirm its safety.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques for treating tendinopathy. Traditional treatments often involve physical therapy or surgery, which can be invasive and require long recovery times. The Percutaneous Ultrasonic Needle Tenotomy (PUT) uses a special ultrasonic device to precisely target and break down damaged tendon tissue, potentially offering a quicker recovery and less pain. Meanwhile, the Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) uses precise imaging to guide a needle for a more accurate treatment. These methods could lead to more effective and less invasive options for patients, reducing downtime and improving outcomes.

What evidence suggests that these tenotomy techniques are effective for gluteal tendinosis?

This trial will compare two techniques for treating tendinopathy: Percutaneous Ultrasonic Tenotomy (PUT) and Ultrasound-Guided Percutaneous Needle Tenotomy (PNT). Studies have shown that both PUT and PNT effectively reduce pain in tendon problems, such as gluteal tendinosis. Research indicates that PUT, which uses a special device with sound waves, has shown promise in relieving pain and improving movement, particularly in conditions like plantar fasciitis. Conversely, PNT, which employs a simple needle guided by ultrasound, has proven effective for persistent tendon pain when other treatments have failed. Some studies suggest short-term benefits, but long-term results between the two methods have not shown major differences. Overall, both techniques are considered safe and effective for treating pain related to tendon issues.13467

Who Is on the Research Team?

KV

Kyle V Goerl, MD

Principal Investigator

University of Colorado Denver, Anschutz Medical Campus

Are You a Good Fit for This Trial?

This trial is for people with gluteal tendinosis (hip tendon problems) confirmed by imaging, who have had symptoms for over 3 months and haven't improved after at least 3 months of non-surgical treatments.

Inclusion Criteria

I have gluteal tendinosis confirmed by a doctor and imaging tests.
I did not get better after 3 months of non-surgical treatment.
I have had symptoms for more than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PNT or PUT for the treatment of gluteal tendinosis

Immediate procedure
1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and physical function post-procedure

4 months
Follow-up assessments at 2 weeks, 6 weeks, 3 months, and 4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Percutaneous Ultrasonic Needle Tenotomy (PUT)
  • Ultrasound-Guided Percutaneous Needle Tenotomy (PNT)

Trial Overview

The study compares two procedures: a traditional needle technique (PNT) versus a newer ultrasound-guided ultrasonic needle method (PUT using the Tenex device), to see which better reduces pain and improves function in hip tendon issues.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Percutaneous needle tenotomy (PNT)Active Control1 Intervention
Group II: Percutaneous ultrasonic tenotomy (PUT, Tenex device)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Citations

Effectiveness of Percutaneous Needle Tenotomy for ... - PMC

To review the current literature of reported outcomes for PNT, TENEX, and TENJET, for the treatment of tendinopathy, including pain relief, ...

Effectiveness of Percutaneous Needle Tenotomy for ... - PMC

The authors conducted a systematic review of the current literature on outcomes after percutaneous ultrasound-guided needle tenotomy (PUNT) for tendinopathy.

Effectiveness of Percutaneous Needle Tenotomy for ...

To review the current literature of reported outcomes for PNT, TENEX, and TENJET, for the treatment of tendinopathy, including pain relief, ...

Ultrasound-Guided Percutaneous Needle Tenotomy (PNT ...

The goal of this study is to determine if a newer tenotomy technique utilizing an ultrasound needle is more effective than the traditional ...

Percutaneous Ultrasonic Tenotomy for Patients with Plantar ...

This study aims to analyze the effectiveness of percutaneous ultrasonic tenotomy (PUT) in patients with plantar fasciitis. Methods. A ...

The Safety of Ultrasound Guided Tenotomy and Debridement ...

Multiple treatments have been reported to alleviate pain and improve function, but short and long-term outcome data are limited. Historically, tendinopathy ...

02.01.68 Percutaneous Ultrasonic Tenotomy and Fasciotomy

Based on review of the current peer reviewed literature there is a lack of randomized controlled trials (RCTs) demonstrating improved net health outcomes of PUT ...