Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)

Conditions

• Greater Trochanteric Pain Syndrome

Eligibility Criteria

Sex

ALL

Age

30 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Mar 11, 2025

Status verified

May 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control
  Standard of care
• Experimental: Treatment
  TENEX device will be used

Primary Outcome Measure

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

Central Contacts

• Tahereh Naeimi, MD
  3479778678
  [email protected]

Locations (1)

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