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NCT Number: NCT07540806

Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis

The goal of this study is to determine if a newer tenotomy technique utilizing an ultrasound needle is more effective than the traditional tenotomy technique utilizing a simple hypodermic needle for gluteal tendinosis. The main questions it aims to answer are:

1. Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques? 2. Is there an improvement in function for gluteal tendinosis, and, if so, is there a difference between techniques?

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Key information

Conditions

Tendinopathy Gluteal Tendinitis Muscular Diseases Musculoskeletal Diseases Tendinosis Tendon Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth CU Sports Medicine - Colorado Center

Denver, Colorado, 80222, United States

About this study

Study Design This study is designed as a single-blinded, randomized control trial with two parallel arms comparing PNT vs PUT device for the treatment of gluteal (medius and minimus) tendinosis with analysis of pain, physical function, activities of daily living (ADLs) and overall health over four months. Participants will be randomly assigned (1:1) to receive PNT or PUT at one academic medical center. Each participant will be assigned a patient ID and randomized to one of the two groups. The participants and outcomes assessors will be blinded to treatment group allocation, but the physician administering treatment will not be blinded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of gluteal (medius and/or minimus) tendinosis confirmed clinically and with ultrasonography or MRI
  • Failure to improve after 3 months of nonoperative treatment
  • Symptoms present for longer than 3 months

Exclusion criteria

  • Patients with concomitant injuries or pain
  • Full thickness tears of the affected tendon
  • Prior corticosteroid injection of the affected tendon within the last 3 months
  • Prior PNT of the affected tendon
  • Significant abnormalities of bony or tendon morphology

Treatment and study plan

Percutaneous needle tenotomy (PNT)

Procedure

Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis

Percutaneous ultrasonic tenotomy (PUT, Tenex Device)

Device

Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis

Primary outcomes

  1. Change from baseline in pain, as measured by the Visual Analog Scale (VAS)

    Time frame: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.

    The VAS measures the severity of pain. Scores range from 0 to 100 mm line with 0 representing no pain and 100 representing the worst pain imaginable.

Secondary outcomes

  1. Change from baseline in physical function, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function grading scale for activities of daily living (ADLs)

    Time frame: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.

    The PROMIS physical function score is a standardized measure of how a person's physical abilities affect their daily life. It is a T-score with a population average of 50 and a standard deviation of 10 with scores above 50 indicating above-average daily function and below 50 indicating below-average physical function. The range of scores is from 20 to 80.

Study contacts

Contact information is provided by the study sponsor or research team.

David Vargas

CONTACT

[email protected]

Kyle V Goerl, MD

CONTACT

[email protected]

3037249700

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 20, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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