TENEX for Trochanteric Bursitis

(RCT GTPS Trial)

Recruiting at 1 trial location

Overseen By Asude N. Hasanoglu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Significant mobility restrictions, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day (outpatient procedure)

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a procedure called TENEX can help individuals with persistent hip pain from Greater Trochanteric Pain Syndrome (GTPS). TENEX uses ultrasound guidance to treat tendons in the hip area, potentially reducing pain and enhancing mobility. The procedure is outpatient, so participants won't need to stay overnight in a hospital. The trial will compare TENEX to standard care. It seeks individuals who have experienced GTPS pain for over six months despite trying other treatments. As an unphased trial, this study offers a unique opportunity to explore a new treatment option that could improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it aims to reduce medication use by improving pain and mobility.

What prior data suggests that the TENEX device is safe for treating Greater Trochanteric Pain Syndrome?

Research has shown that the TENEX device is generally safe for treating tendon problems. Studies indicate that 90% of patients using TENEX avoided open surgery, suggesting it is well-tolerated. Only 10% of patients did not achieve successful results and required further treatment. This indicates that most people using TENEX had a positive experience without serious issues.

Another study examined TENEX for a specific hip condition and found it to be a safe and effective option. This research reported no major safety concerns. Overall, the evidence suggests that TENEX is a promising treatment with a good safety record for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TENEX for trochanteric bursitis because it offers a minimally invasive alternative to traditional treatments like physical therapy, corticosteroid injections, and pain medications. Unlike these standard care options, which can take weeks or require repeated sessions, TENEX uses ultrasound to precisely target and remove damaged tissue, potentially providing quicker relief. This innovative approach means less downtime and a faster return to daily activities, making it a promising option for those seeking effective and efficient pain relief.

What evidence suggests that the TENEX device is effective for Greater Trochanteric Pain Syndrome?

Research has shown that the TENEX procedure may help treat conditions like Greater Trochanteric Pain Syndrome (GTPS). In some studies, patients reported a significant reduction in pain, with levels decreasing from a 7 to a 2 on average. This trial will evaluate the effectiveness of the TENEX procedure, which uses ultrasound to guide the treatment of tendons in the hip area, aiming to reduce pain, improve movement, and lessen the need for pain medication. While early results are promising, researchers continue to study this outpatient treatment to confirm its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Sayed E. Wahezi, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with Greater Trochanteric Pain Syndrome (GTPS) confirmed by MRI or CT scan, who haven't improved after at least 6 months of standard medical treatment. It's not suitable for those who've had previous surgery on the affected tendons or have significant mobility restrictions like wheelchair users.

Inclusion Criteria

My hip pain is diagnosed as GTPS confirmed by MRI or CT scan.

I can understand and sign consent forms on my own.

My condition hasn't improved after 6 months of standard treatment.

Exclusion Criteria

I use a wheelchair due to significant mobility restrictions.

I have had surgery on my hip or side thigh area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound-guided percutaneous tenotomy using the TENEX device

1 day (outpatient procedure)

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and quality of life improvements post-treatment

2 years

Visits at 1 month, 3 months, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• TENEX

Trial Overview

The study tests TENEX, a device used in percutaneous tenotomy to partially release certain tendons around the hip under ultrasound guidance. The goal is to see if this minimally invasive procedure can reduce pain and improve functions such as walking and standing in GTPS patients.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

TENEX device will be used

Group II: Control Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3689218/

Efficacy of Treatment of Trochanteric Bursitis: A Systematic ...

The only one to offer comparative outcome scores had a failure rate of 31% (5 of 16) due to rerupture or infection but reported a VAS improvement of 5 (7 vs 2) ...

2.

trialx.com

trialx.com/clinical-trials/listings/297667/evaluation-of-tenex-for-greater-trochanteric-pain-syndrome-gtps/

Evaluation of TENEX for Greater Trochanteric Pain ...

The study predicts that this percutaneous outpatient procedure can decrease pain, increase mobility, and decrease medication utilization. The ...

3.

bostonsportsandbiologics.com

bostonsportsandbiologics.com/blog/tenex-and-tenotomy-for-gluteal-bursitis-whats-the-evidence

Tenex and Tenotomy for Gluteal "Bursitis"

Corticosteroid injections have been shown to provide short-term relief of pain associated with gluteus medius tendinopathy, with 72% to 75% of cases reporting ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/6e547a5aa4dc0701/nct05710627-evaluation-percutaneous-tenotomy-gluteus-medius-iliotibial-band-greater-trochanteric-pain

Evaluation of TENEX for Greater Trochanteric Pain Syndrome ...

The study predicts that this percutaneous outpatient procedure can decrease pain, increase mobility, and decrease medication utilization. The study team ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0031940624000026

Systematic review Exercise compared to a control ...

Exercise is effective for slightly reducing hip pain and disease severity while slightly improving physical function and global rating of change.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7082875/

Ultrasound-Guided Percutaneous Tenotomy for Gluteal ...

Patients were evaluated for an average of 22 months (median, 20 months; range, 18-30 months); 3 patients (10%) had failed results and went on to ...

7.

bostonsportsandbiologics.com

bostonsportsandbiologics.com/blog/hip-bursitis-gluteal-tendinopathy-tenex

Our blog

In this study, 90% of patients were able to avoid an open surgery with the tenotomy procedure with Tenex. Only 10% of patients failed the Tenex ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04299802

Percutaneous Ultrasonic Tenotomy Versus Platelet Rich ...

The primary objective of this study is to evaluate safety and effectiveness of both a single percutaneous ultrasonic tenotomy or a single injection of LR-PRP in ...

9.

painphysicianjournal.com

painphysicianjournal.com/current/pdf?article=NzY5OA%3D%3D&journal=153

Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial ...

Conclusions: PUT of the ITB using the TENEX® tissue remodeling device could be a safe and effective treatment for ITB tendinopathy-associated GTPS. Key words: ...