RecruitingNot ApplicableNCT05710627

Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)

Evaluation of Percutaneous Tenotomy of the Gluteus Medius and Iliotibial Band for Greater Trochanteric Pain Syndrome (GTPS): A Randomized Clinical Trial


Sponsor

Montefiore Medical Center

Enrollment

150 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate how an ultrasound-guided percutaneous procedure, TENEX, can help people with chronic hip pain resulting from a condition called Greater Trochanteric Pain Syndrome (GTPS) and to characterize the efficacy of percutaneous tenotomy (PUT) using TENEX®, a device used for the treatment of various tendinopathies. In this study an ultrasound (US) is performed to guide the partial release of gluteus medius and minimus and Iliotibial band tendons in patients diagnosed with refractory Greater Trochanteric Pain Syndrome (GTPS) vs control. The investigator team hypothesizes that the new TENEX can improve the pain level for individuals with GTPS to help those individuals perform their activities of daily living (ADLs), e.g., walking, standing, and side-lying, as well as demonstrate less medication utilization. The study predicts that this percutaneous outpatient procedure can decrease pain, increase mobility, and decrease medication utilization. The study team hypothesizes that PUT can improve the pain level and function for individuals suffering with GTPS. The study will assess walking, standing, and side-lying tolerance, as well as medication utilization. The investigator team predicts that this percutaneous outpatient procedure can decrease pain and medication utilization while increasing mobility.


Eligibility

Min Age: 30 YearsMax Age: 90 Years

Inclusion Criteria4

  • Aged 18-90
  • People with GTPS of all different levels and etiologies confirmed with MRI or CT scan
  • Ability to give informed consent forms independently
  • Failed conservative medical treatment for at least 6 months

Exclusion Criteria3

  • Significant mobility restrictions; people using wheelchairs
  • Pregnancy
  • Previous surgery to the GMed or ITB

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Interventions

DEVICETENEX

Use of TENEX device for sectioning of the gluteus medius and ITB tendons.


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT05710627


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