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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous needle tenotomy (PNT) | Active Comparator | Traditional tenotomy technique utilizing a hypodermic needle. |
|
| Percutaneous ultrasonic tenotomy (PUT, Tenex device) | Active Comparator | Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous needle tenotomy (PNT) | Procedure | Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure. |
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyle V Goerl, MD | Contact | 3037249700 | kyle.goerl@cuanschutz.edu | |
| David Vargas | Contact | juan.2.vargas@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kyle V Goerl, MD | University of Colorado Denver, Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth CU Sports Medicine - Colorado Center | Denver | Colorado | 80222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27519477 | Background | 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. | |
| 33414454 | Background | Millar 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. |
| Label | URL |
|---|---|
| White Paper on the tenotomy device, TendoNova Ocelot | View source |
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| Percutaneous ultrasonic tenotomy (PUT, Tenex Device) | Device | Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis |
|
| Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure. |
| 35543668 | Background | Hurley 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. |
| 27610386 | Background | Zhou 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. |
| 35859290 | Background | Smallcomb 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. |
| 35896736 | Background | Shomal 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. |
| 21872551 | Background | Finnoff 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. |
| 18645071 | Background | McShane 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. |
| 18604073 | Background | Lakhey 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. |
| 29428875 | Background | Bradberry 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. |
| 39238190 | Background | Maag 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. |
| 37535779 | Background | Wahezi 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. |
| 27663654 | Background | Jacobson 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. |
| 33644963 | Background | Kirschner 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. |
| 32232066 | Background | Baker 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. |
| 29238734 | Background | Gaspar MP, Motto MA, Lewis S, Jacoby SM, Culp RW, Lee Osterman A, Kane PM. Platelet-Rich Plasma Injection With Percutaneous Needling for Recalcitrant Lateral Epicondylitis: Comparison of Tenotomy and Fenestration Techniques. Orthop J Sports Med. 2017 Dec 6;5(12):2325967117742077. doi: 10.1177/2325967117742077. eCollection 2017 Dec. |
| 33358122 | Background | Carlier Y, Bonichon F, Peuchant A. Recalcitrant lateral epicondylitis: Early results with a new technique combining ultrasonographic percutaneous tenotomy with platelet-rich plasma injection. Orthop Traumatol Surg Res. 2021 Apr;107(2):102604. doi: 10.1016/j.otsr.2020.03.016. Epub 2021 Jan 6. |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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