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TENEX for Trochanteric Bursitis (RCT GTPS Trial)
N/A
Waitlist Available
Led By Sayed E. Wahezi, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month
Awards & highlights
RCT GTPS Trial Summary
This trial assesses whether a device used to treat tendinopathies can reduce pain and medication use, and improve mobility in people with refractory GTPS.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, procedures like TENEX could potentially cause discomfort at the site of treatment, bruising, swelling, infection risk or temporary increase in pain before improvement.
RCT GTPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Level
Secondary outcome measures
EQ-5D-5L
RCT GTPS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
TENEX device will be used
Group II: ControlActive Control1 Intervention
Standard of care
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
444 Previous Clinical Trials
582,443 Total Patients Enrolled
Sayed E. Wahezi, MDPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use a wheelchair due to significant mobility restrictions.My hip pain is diagnosed as GTPS confirmed by MRI or CT scan.I am between 18 and 90 years old.I can understand and sign consent forms on my own.I have had surgery on my hip or side thigh area before.My condition hasn't improved after 6 months of standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants being accepted at this moment for the trial?
"According to the information available on clinicaltrials.gov, this research project is not currently recruiting patients. It was first listed on August 1st 2023 and most recently updated April 26th 2003; however 1480 other trials are presently in search of participants."
Answered by AI
Is this research endeavor recruiting individuals over the age of 40?
"The age range for enrolment into this clinical trial is 18-90, as per the inclusion criteria."
Answered by AI
Am I eligible to participate in this clinical research?
"This medical endeavour is looking for 117 participants between 18 and 90 afflicted by trochanteric bursitis. Notably, all candidates must have experienced a lack of success when using conventional remedies over the past 6 months or more."
Answered by AI
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