Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous needle tenotomy (PNT), Percutaneous ultrasonic tenotomy (PUT, Tenex Device).
- Who it may be relevant to
- Registry conditions: Tendinopathy, Tendinosis, Gluteal Tendinitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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?
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
- Procedure Percutaneous needle tenotomy (PNT)
Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis - Device Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis
Primary outcome measures
- 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.]
Secondary outcome measures (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) [Time frame: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UCHealth CU Sports Medicine - Colorado Center — Denver
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. PMID 27519477
- 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. PMID 33414454
- 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. PMID 35543668
- 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. PMID 27610386
- 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. PMID 35859290
- 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. PMID 35896736
- 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. PMID 21872551
- 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. PMID 18645071
Identifiers
NCT: NCT07540806 · 25-1380