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

May 13, 2026 updated by: University of Colorado, Denver

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80222
        • UCHealth CU Sports Medicine - Colorado Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous needle tenotomy (PNT)
Traditional tenotomy technique utilizing a hypodermic needle.
Procedure: Percutaneous needle tenotomy (PNT)
Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis
Active Comparator: Percutaneous ultrasonic tenotomy (PUT, Tenex device)
Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex)
Device: Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Kyle V Goerl, MD, University of Colorado Denver, Anschutz Medical Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-1380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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