Greater Trochanteric Pain SyndromeRCT GTPSNCT05710627
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
A study testing TENEX in people with Greater Trochanteric Pain Syndrome, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Greater Trochanteric Pain Syndrome
- What is being tested?
- TENEX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant mobility restrictions; people using wheelchairs
- Pregnancy
- Previous surgery to the GMed or ITB
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Tahereh Naeimi, MD, 347-977-8678, tnaeimi@montefiore.org
Sayed E. Wahezi, MD
About this study
Official title: Evaluation of Percutaneous Tenotomy of the Gluteus Medius and Iliotibial Band for Greater Trochanteric Pain Syndrome (GTPS): A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Greater Trochanteric Pain Syndrome
- Being tested
- TENEX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENEXDevice
Use of TENEX device for sectioning of the gluteus medius and ITB tendons.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Treatment | Experimental | TENEX device will be used Receives: Device: TENEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
A comparative analysis between TENEX to conventional medical treatments will be conducted using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed. The EQ-5D-5L is a descriptive system which 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 are combined into a five-digit number that describes the patient's health state. Results will be summarized by study arm.
Measured: Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start11 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sayed E. Wahezi, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710627
- Sponsor's protocol ID
- 2022-14588
- Acronym
- RCT GTPS
- Status last verified
- May 2026
- First submitted
- 24 Jan 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 17678660Baker 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.
PubMed 32232066Del 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.
PubMed 21893483Mellor 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.
PubMed 27139495Chandrasekaran 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.
PubMed 26033462Wahezi 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.
PubMed 37535779
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Percutaneous Tenotomy of the Gluteus Medius and Iliotibial Band for Greater Trochanteric Pain Syndrome (GTPS): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05710627
- Acronym / sponsor ID
- RCT GTPS / 2022-14588
- Conditions
- Greater Trochanteric Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Treatment | Experimental | Device: TENEXTENEX device will be used |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Significant mobility restrictions; people using wheelchairs
- Pregnancy
- Previous surgery to the GMed or ITB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENEXUse of TENEX device for sectioning of the gluteus medius and ITB tendons. | Device | Treatment |
Primary outcome
Pain Level
Time frame: Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years
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.
1 secondary outcome
Quality of Life using the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time frame: Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 17678660Segal 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.
- Background: PubMed 32232066Baker 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.
- Background: PubMed 21893483Del 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.
- Background: PubMed 27139495Mellor 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.
- Background: PubMed 26033462Chandrasekaran 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.
- Background: PubMed 37535779Wahezi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sayed E. Wahezi, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENEX in people with Greater Trochanteric Pain Syndrome, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tahereh Naeimi, MD (3479778678, tnaeimi@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710627, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.