Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)

NCT05710627 | Recruiting DMC FDA Device

• 1 other identifier: 2022-14588
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain Level

  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 will be considered successful.

  Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years

Secondary Outcomes (1)

• Quality of Life using the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

  Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Treatment

EXPERIMENTAL

TENEX device will be used

Device: TENEX

Interventions

TENEX DEVICE

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

Treatment

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant mobility restrictions; people using wheelchairs
• Pregnancy
• Previous surgery to the GMed or ITB

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (6)

• Segal NA, Felson DT, Torner JC, Zhu Y, Curtis JR, Niu J, Nevitt MC; Multicenter Osteoarthritis Study Group. Greater trochanteric pain syndrome: epidemiology and associated factors. Arch Phys Med Rehabil. 2007 Aug;88(8):988-92. doi: 10.1016/j.apmr.2007.04.014.

  PMID: 17678660 BACKGROUND

• Baker CL Jr, Mahoney JR. Ultrasound-Guided Percutaneous Tenotomy for Gluteal Tendinopathy. Orthop J Sports Med. 2020 Mar 19;8(3):2325967120907868. doi: 10.1177/2325967120907868. eCollection 2020 Mar.

  PMID: 32232066 BACKGROUND

• Del Buono A, Papalia R, Khanduja V, Denaro V, Maffulli N. Management of the greater trochanteric pain syndrome: a systematic review. Br Med Bull. 2012 Jun;102:115-31. doi: 10.1093/bmb/ldr038. Epub 2011 Sep 4.

  PMID: 21893483 BACKGROUND

• Mellor R, Grimaldi A, Wajswelner H, Hodges P, Abbott JH, Bennell K, Vicenzino B. Exercise and load modification versus corticosteroid injection versus 'wait and see' for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial. BMC Musculoskelet Disord. 2016 Apr 30;17:196. doi: 10.1186/s12891-016-1043-6.

  PMID: 27139495 BACKGROUND

• Chandrasekaran S, Lodhia P, Gui C, Vemula SP, Martin TJ, Domb BG. Outcomes of Open Versus Endoscopic Repair of Abductor Muscle Tears of the Hip: A Systematic Review. Arthroscopy. 2015 Oct;31(10):2057-67.e2. doi: 10.1016/j.arthro.2015.03.042. Epub 2015 May 29.

  PMID: 26033462 BACKGROUND

• Wahezi SE, Patel A, Yerra S, Naeimi T, Sayed D, Oakes D, Ortiz N, Yee M, Yih C, Sitapara K, Schulz J, Kohan L, Rosenburg J, Schwechter E, Chan F, Gonzalez D, Baker C. Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial Band for Trochanteric Pain Syndrome: A Longitudinal Observational Study With One-Year Durability Results. Pain Physician. 2023 Jul;26(4):393-401.

  PMID: 37535779 BACKGROUND

Study Officials

• Sayed E. Wahezi, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tahereh Naeimi, MD

CONTACT

3479778678; tnaeimi@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 100 patients will be enrolled in the TENEX group and 50 patients in the control group accounting for 10% rate of loss-to-follow-up. 10 pre computer-generated blocks, consisting of 15 patients in each block, will be generated. In each block, 5 patients will be assigned to CMM and 10 to the Tenex group. Patients will be assigned to each group by the order that computer has created.

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)