TENEX for Trochanteric Bursitis
(RCT GTPS Trial)
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ultrasound-guided percutaneous tenotomy using the TENEX device
Follow-up
Participants are monitored for pain levels and quality of life improvements post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- TENEX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor