Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (RCT GTPS)

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

The aim of this study is 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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Greater Trochanteric Pain Syndrome
• Intervention / Treatment: Device: TENEX

Detailed Description

Greater trochanteric pain syndrome (GTPS) is one of the most common causes of lateral hip pain in adults. GTPS is repetitive overload tendinopathy of the gluteus medius (GMed) and Iliotibial band (ITB), which play a primary role in hip abduction and pelvic stabilization in walking, stair climbing, running and standing on one leg. It is thought that the core pathology is greater trochanteric bursitis (TB) with or without coexisting gluteal tendinopathy. Some common etiologies include prolonged excessive pressure to the area, injury to the side of the hip, and repetitive movements; however, local steroid injections to the greater TB are not often successful over the long-term. The best estimates of prevalence are from a large, community-based study with over 3000 adults aged 50 to 70 years, in which unilateral GTPS was present in 15 percent of women and 6.6 percent of men. Patients who have not improved after at least 12 months of conservative medical management (CMM), including physical therapy, oral medications, or a local steroid injection have no other conservative treatment recourse. Open surgery for GMed or ITB tears is not recommended unless a tear is diagnosed on MRI. Based on a published study, a 60% improvement was shown in pain with the performance of TENEX of the GMed.

The purpose of this project is to study the outcome of GMed and ITB PUT on CMM refractory GTPS. We want to quantify and show the scales of the pain in pre-operative and post-treatment cases. We also want to see how effective the surgery is in specific terms of pain levels because GTPS is a pain syndrome and reduction in pain level is the most important clinical factor.

Patient Reported Outcome Measure (PROM) is one of the main outcomes that medical research is validated with and through this study we want to show the most important outcome of GTPS i.e., pain level (PROM for GTPS). Previous studies which focused on surgical outcomes have been mostly single-center trials.

Pain and mobility impact patients' Quality of Life (QoL) and medical cost burden due to unemployment, psychosocial well-being, and functional dependence. The standard of care offered to address the pain and mobility needs of those with GTPS is to provide CMM, followed by open or arthroscopic surgery if surgery is indicated. However, there is a treatment gap for those patients who have failed CMM and are not surgical candidates. The authors submit that TENEX of the GMed and ITB may address this gap. The results from this research may have broad impacts on the treatment algorithm for patients with GTPS.

• Study Type: Interventional
• Enrollment (Estimated): 117
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tahereh Naeimi, MD; Phone Number: 3479778678; Email: tnaeimi@montefiore.org
• Study Contact Backup: Name: Asude N. Hasanoglu, MD; Phone Number: 9293778185; Email: ahasanoglu@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
      • Contact: Tahereh Naeimi, MD; Phone Number: 3479778678; Email: tnaeimi@montefiore.org
      • Contact: Asude N. Hasanoglu, MD; Phone Number: 929-377-8185; Email: ahasanoglu@montefiore.org
      • Principal Investigator: Sayed E. Wahezi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Previous surgery to the GMed or ITB

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: Treatment; TENEX device will be used	Device: TENEX; Use of TENEX device for sectioning of the gluteus medius and ITB tendons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 FU visits. 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.	Baseline (before the procedure)
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 FU visits. 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.	1-month
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 FU visits. 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.	3-month
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 FU visits. 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.	6-month
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 FU visits. 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.	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L	In this study, we will also explore a comparative analysis between TENEX to conventional medical treatments. The study team will compare quality of life using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed as well. EQ-5D-5L is the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1- digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a five digit number that describes the patient's health state.	Baseline (before the procedure)
EQ-5D-5L	In this study, we will also explore a comparative analysis between TENEX to conventional medical treatments. The study team will compare quality of life using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed as well. EQ-5D-5L is the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1- digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a five digit number that describes the patient's health state.	1-month
EQ-5D-5L	In this study, we will also explore a comparative analysis between TENEX to conventional medical treatments. The study team will compare quality of life using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed as well. EQ-5D-5L is the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1- digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a five digit number that describes the patient's health state.	3-month
EQ-5D-5L	In this study, we will also explore a comparative analysis between TENEX to conventional medical treatments. The study team will compare quality of life using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed as well. EQ-5D-5L is the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1- digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a five digit number that describes the patient's health state.	6-month
EQ-5D-5L	In this study, we will also explore a comparative analysis between TENEX to conventional medical treatments. The study team will compare quality of life using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed as well. EQ-5D-5L is the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1- digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a five digit number that describes the patient's health state.	12-month

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Sayed E. Wahezi, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Bursitis
• Other Study ID Numbers: 2022-14588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes