Recruiting

TENEX

Sponsor:

Montefiore Medical Center

Code:

NCT05710627

Conditions

Greater Trochanteric Pain Syndrome

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

TENEX

Study Details

Brief 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.

Conditions

Greater Trochanteric Pain Syndrome

Study ID

NCT05710627

Start date

Mar 11, 2025

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Standard of care

experimental: Treatment

TENEX device will be used

Interventions

TENEX

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

Primary outcome measure

  • Pain Level [ Time Frame: Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years ]

Central Contacts and Locations

Central contacts

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Principal Investigator:

Sayed E. Wahezi, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-05-08.