Gluteal Tendinitis, Tendinopathy, Tendinosis
Conditions
Keywords
Tendinopathy, Tendinosis, Gluteal tendinosis, Tenotomy, Percutaneous needle tenotomy, Percutaneous ultrasonic tenotomy
Brief summary
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?
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.
Interventions
PROCEDUREPercutaneous needle tenotomy (PNT)
Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis
DEVICEPercutaneous ultrasonic tenotomy (PUT, Tenex Device)
Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain, as measured by the Visual Analog Scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
United States
Contacts
CONTACTKyle V Goerl, MD
CONTACTDavid Vargas
PRINCIPAL_INVESTIGATORKyle V Goerl, MD
University of Colorado Denver, Anschutz Medical Campus
Outcome results
None listed