TendinopathyNCT07540806
Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis
A study testing Percutaneous needle tenotomy (PNT) and Percutaneous ultrasonic tenotomy (PUT, Tenex Device) in people with Tendinopathy and Tendinosis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendinopathy, Tendinosis, Gluteal Tendinitis
- What is being tested?
- Percutaneous needle tenotomy (PNT) and Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Vargas contact
United States1 site
UCHealth CU Sports Medicine - Colorado Center
Denver, Colorado, 80222
About this study
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:
- Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques?
- Is there an improvement in function for gluteal tendinosis, and, if so, is there a difference between techniques?
Read the 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.
- Conditions
- Tendinopathy, Tendinosis, Gluteal Tendinitis
- Being tested
- Percutaneous needle tenotomy (PNT), Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
- Keywords
- Tendinopathy, Tendinosis, Gluteal tendinosis, Tenotomy, Percutaneous needle tenotomy, Percutaneous ultrasonic tenotomy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous needle tenotomy (PNT)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous needle tenotomy (PNT) | Active comparator | Traditional tenotomy technique utilizing a hypodermic needle. Receives: Procedure: Percutaneous needle tenotomy (PNT) |
| Percutaneous ultrasonic tenotomy (PUT, Tenex device) | Active comparator | Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex) Receives: Device: Percutaneous ultrasonic tenotomy (PUT, Tenex Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.
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)
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.
Measured: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle V Goerl, MD, Principal investigator, University of Colorado Denver, Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540806
- Sponsor's protocol ID
- 25-1380
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yelin E, Weinstein S, King T. The burden of musculoskeletal diseases in the United States. Semin Arthritis Rheum. 2016 Dec;46(3):259-260. doi: 10.1016/j.semarthrit.2016.07.013. Epub 2016 Jul 26. No abstract available.
PubMed 27519477Millar NL, Silbernagel KG, Thorborg K, Kirwan PD, Galatz LM, Abrams GD, Murrell GAC, McInnes IB, Rodeo SA. Tendinopathy. Nat Rev Dis Primers. 2021 Jan 7;7(1):1. doi: 10.1038/s41572-020-00234-1.
PubMed 33414454Hurley ET, Mojica ES, Kanakamedala AC, Meislin RJ, Strauss EJ, Campbell KA, Alaia MJ. Quadriceps tendon has a lower re-rupture rate than hamstring tendon autograft for anterior cruciate ligament reconstruction - A meta-analysis. J ISAKOS. 2022 Apr;7(2):87-93. doi: 10.1016/j.jisako.2021.10.001. Epub 2021 Nov 17.
PubMed 35543668Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16.
PubMed 27610386Smallcomb M, Khandare S, Vidt ME, Simon JC. Therapeutic Ultrasound and Shockwave Therapy for Tendinopathy: A Narrative Review. Am J Phys Med Rehabil. 2022 Aug 1;101(8):801-807. doi: 10.1097/PHM.0000000000001894. Epub 2021 Oct 4.
PubMed 35859290Shomal Zadeh F, Shafiei M, Hosseini N, Alipour E, Cheung H, Chalian M. The effectiveness of percutaneous ultrasound-guided needle tenotomy compared to alternative treatments for chronic tendinopathy: a systematic review. Skeletal Radiol. 2023 May;52(5):875-888. doi: 10.1007/s00256-022-04140-3. Epub 2022 Jul 28.
PubMed 35896736Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26.
PubMed 21872551McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44. doi: 10.7863/jum.2008.27.8.1137.
PubMed 18645071Lakhey S, Mansfield M, Pradhan RL, Rijal KP, Paney BP, Manandhar RR. Percutaneous extensor tenotomy for chronic tennis elbow using an 18G needle. Kathmandu Univ Med J (KUMJ). 2007 Oct-Dec;5(4):446-8.
PubMed 18604073Bradberry DM, Sussman WI, Mautner KR. Ultrasound-Guided Percutaneous Needle Tenotomy for Chronic Tensor Fascia Lata Tendinopathy: A Case Series and Description of Sonographic Findings. PM R. 2018 Sep;10(9):979-983. doi: 10.1016/j.pmrj.2018.01.009. Epub 2018 Feb 8.
PubMed 29428875Maag L, Linder S, Hackett L, Mitchkash M, Farley T, Lamar D, Fisher N, Burnham B. Effectiveness of Percutaneous Needle Tenotomy for Tendinopathies: A Systematic Review. Sports Health. 2025 Jul;17(4):834-842. doi: 10.1177/19417381241275659. Epub 2024 Sep 5.
PubMed 39238190Wahezi SE, Patel A, Yerra S, Naeimi T, Sayed D, Oakes D, Ortiz N, Yee M, Yih C, Sitapara K, Schulz J, Kohan L, Rosenburg J, Schwechter E, Chan F, Gonzalez D, Baker C. Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial Band for Trochanteric Pain Syndrome: A Longitudinal Observational Study With One-Year Durability Results. Pain Physician. 2023 Jul;26(4):393-401.
PubMed 37535779Jacobson JA, Yablon CM, Henning PT, Kazmers IS, Urquhart A, Hallstrom B, Bedi A, Parameswaran A. Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis. J Ultrasound Med. 2016 Nov;35(11):2413-2420. doi: 10.7863/ultra.15.11046. Epub 2016 Sep 23.
PubMed 27663654Kirschner JS, Cheng J, Hurwitz N, Santiago K, Lin E, Beatty N, Kingsbury D, Wendel I, Milani C. Ultrasound-guided percutaneous needle tenotomy (PNT) alone versus PNT plus platelet-rich plasma injection for the treatment of chronic tendinosis: A randomized controlled trial. PM R. 2021 Dec;13(12):1340-1349. doi: 10.1002/pmrj.12583. Epub 2021 Apr 28.
PubMed 33644963Baker CL Jr, Mahoney JR. Ultrasound-Guided Percutaneous Tenotomy for Gluteal Tendinopathy. Orthop J Sports Med. 2020 Mar 19;8(3):2325967120907868. doi: 10.1177/2325967120907868. eCollection 2020 Mar.
PubMed 32232066
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis
- ClinicalTrials.gov ID
- NCT07540806
- Acronym / sponsor ID
- 25-1380
- Conditions
- Tendinopathy, Tendinosis, Gluteal Tendinitis
- Keywords
- Tendinopathy, Tendinosis, Gluteal tendinosis, Tenotomy, Percutaneous needle tenotomy, Percutaneous ultrasonic tenotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous needle tenotomy (PNT) | Active comparator | Procedure: Percutaneous needle tenotomy (PNT)Traditional tenotomy technique utilizing a hypodermic needle. |
| Percutaneous ultrasonic tenotomy (PUT, Tenex device) | Active comparator | Device: Percutaneous ultrasonic tenotomy (PUT, Tenex Device)Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous needle tenotomy (PNT)Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis | Procedure or surgery | Percutaneous needle tenotomy (PNT) |
| Percutaneous ultrasonic tenotomy (PUT, Tenex Device)Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis | Device | Percutaneous ultrasonic tenotomy (PUT, Tenex device) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 27519477Yelin E, Weinstein S, King T. The burden of musculoskeletal diseases in the United States. Semin Arthritis Rheum. 2016 Dec;46(3):259-260. doi: 10.1016/j.semarthrit.2016.07.013. Epub 2016 Jul 26. No abstract available.
- Background: PubMed 33414454Millar NL, Silbernagel KG, Thorborg K, Kirwan PD, Galatz LM, Abrams GD, Murrell GAC, McInnes IB, Rodeo SA. Tendinopathy. Nat Rev Dis Primers. 2021 Jan 7;7(1):1. doi: 10.1038/s41572-020-00234-1.
- Background: PubMed 35543668Hurley ET, Mojica ES, Kanakamedala AC, Meislin RJ, Strauss EJ, Campbell KA, Alaia MJ. Quadriceps tendon has a lower re-rupture rate than hamstring tendon autograft for anterior cruciate ligament reconstruction - A meta-analysis. J ISAKOS. 2022 Apr;7(2):87-93. doi: 10.1016/j.jisako.2021.10.001. Epub 2021 Nov 17.
- Background: PubMed 27610386Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16.
- Background: PubMed 35859290Smallcomb M, Khandare S, Vidt ME, Simon JC. Therapeutic Ultrasound and Shockwave Therapy for Tendinopathy: A Narrative Review. Am J Phys Med Rehabil. 2022 Aug 1;101(8):801-807. doi: 10.1097/PHM.0000000000001894. Epub 2021 Oct 4.
- Background: PubMed 35896736Shomal Zadeh F, Shafiei M, Hosseini N, Alipour E, Cheung H, Chalian M. The effectiveness of percutaneous ultrasound-guided needle tenotomy compared to alternative treatments for chronic tendinopathy: a systematic review. Skeletal Radiol. 2023 May;52(5):875-888. doi: 10.1007/s00256-022-04140-3. Epub 2022 Jul 28.
- Background: PubMed 21872551Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26.
- Background: PubMed 18645071McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44. doi: 10.7863/jum.2008.27.8.1137.
- Background: PubMed 18604073Lakhey S, Mansfield M, Pradhan RL, Rijal KP, Paney BP, Manandhar RR. Percutaneous extensor tenotomy for chronic tennis elbow using an 18G needle. Kathmandu Univ Med J (KUMJ). 2007 Oct-Dec;5(4):446-8.
- Background: PubMed 29428875Bradberry DM, Sussman WI, Mautner KR. Ultrasound-Guided Percutaneous Needle Tenotomy for Chronic Tensor Fascia Lata Tendinopathy: A Case Series and Description of Sonographic Findings. PM R. 2018 Sep;10(9):979-983. doi: 10.1016/j.pmrj.2018.01.009. Epub 2018 Feb 8.
- Background: PubMed 39238190Maag L, Linder S, Hackett L, Mitchkash M, Farley T, Lamar D, Fisher N, Burnham B. Effectiveness of Percutaneous Needle Tenotomy for Tendinopathies: A Systematic Review. Sports Health. 2025 Jul;17(4):834-842. doi: 10.1177/19417381241275659. Epub 2024 Sep 5.
- Background: PubMed 37535779Wahezi SE, Patel A, Yerra S, Naeimi T, Sayed D, Oakes D, Ortiz N, Yee M, Yih C, Sitapara K, Schulz J, Kohan L, Rosenburg J, Schwechter E, Chan F, Gonzalez D, Baker C. Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial Band for Trochanteric Pain Syndrome: A Longitudinal Observational Study With One-Year Durability Results. Pain Physician. 2023 Jul;26(4):393-401.
- White Paper on the tenotomy device, TendoNova OcelotLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Vargas contact
Kyle V Goerl, MD principal investigator
University of Colorado Denver, Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous needle tenotomy (PNT) and Percutaneous ultrasonic tenotomy (PUT, Tenex Device) in people with Tendinopathy and Tendinosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle V Goerl, MD (3037249700, kyle.goerl@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07540806, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.