Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-90
SponsorMontefiore Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Significant mobility restrictions; people using wheelchairs

Pregnancy

Previous surgery to the GMed or ITB

Trial design

Treatments tested in this trial

  • TENEX

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators