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NCT05710627 · ClinicalTrials.gov registry record · NA
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
A NA study of Greater Trochanteric Pain Syndrome, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05710627: Recruiting NA study of Greater Trochanteric Pain Syndrome, sponsored by Montefiore Medical Center.
NCT05710627 is a NA study of Greater Trochanteric Pain Syndrome that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05710627, a NA study of Greater Trochanteric Pain Syndrome, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The difference in pain levels in patients before and after the procedure. Pain levels (NRS scale) recorded in the pre-operative visit will be compared to the pain levels at follow-up (FU) visits. The Numeric rating scale (NRS) is a pain screening tool used to assess pain severity using a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. Pain level scores will be summarized by study arm. Achievement of 50% reduction in pain level from baseline at 6 months post treatment
Conditions Studied
Interventions
- DEVICE TENEX
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-03-11 |
| Est. Completion | 2027-03 |
| Phase | NA |
What NCT05710627 shows while recruiting
NCT05710627 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Greater Trochanteric Pain Syndrome appearing as the primary indexed condition, and to 1 intervention - of which TENEX is the first listed.
NCT05710627 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05710627 about?
NCT05710627 is a clinical study titled "Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)". 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 ...
What is the current status of trial NCT05710627?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2025-03-11. Estimated completion is 2027-03.
What conditions does trial NCT05710627 study?
This clinical trial studies the following conditions: Greater Trochanteric Pain Syndrome.
What interventions are being tested in trial NCT05710627?
The interventions under investigation include: TENEX (DEVICE).
Who is sponsoring clinical trial NCT05710627?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05710627 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05710627's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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