RECRUITING

Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-11
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05710627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-90
  2. * People with GTPS of all different levels and etiologies confirmed with MRI or CT scan
  3. * Ability to give informed consent forms independently
  4. * Failed conservative medical treatment for at least 6 months
  1. * Significant mobility restrictions; people using wheelchairs
  2. * Pregnancy
  3. * Previous surgery to the GMed or ITB

Contacts and Locations

Study Contact

Tahereh Naeimi, MD
CONTACT
3479778678
tnaeimi@montefiore.org

Principal Investigator

Sayed E. Wahezi, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Sayed E. Wahezi, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-11
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-03-11
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Greater Trochanteric Pain Syndrome