NCT05710627 Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
| NCT ID | NCT05710627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Greater Trochanteric Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-03-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sayed E. Wahezi, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05710627 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 90 Years, studying Greater Trochanteric Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05710627 currently recruiting?
Yes, NCT05710627 is actively recruiting participants. Contact the research team at tnaeimi@montefiore.org for enrollment information.
Where is the NCT05710627 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05710627 clinical trial?
NCT05710627 is sponsored by Montefiore Medical Center. The principal investigator is Sayed E. Wahezi, MD at Montefiore Medical Center. The trial plans to enroll 150 participants.