An interventional study of Percutaneous needle tenotomy (PNT) and Percutaneous ultrasonic tenotomy (PUT, Tenex Device) in Tendinopathy, Tendinosis and Gluteal Tendinitis, sponsored by University of Colorado, Denver. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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:
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.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 110 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional tenotomy technique utilizing a hypodermic needle.
Procedure: Percutaneous needle tenotomy (PNT)
Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex)
Device: Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis
Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis
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.
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.
Time frame: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.
Plan to share: No
Start is estimated for Jun 2026; primary completion for Dec 2027, 18 months later.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 18 months is close to that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →