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

N/ANot Yet RecruitingNCT07540806

University of Colorado, Denver110 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Tendinopathy Tendinosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

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)

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.