Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
ConditionGreater Trochanteric Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-90
SponsorMontefiore Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Significant mobility restrictions; people using wheelchairs
Pregnancy
Previous surgery to the GMed or ITB
Trial design
Design model
Parallel
Treatments tested in this trial
TENEX
DeviceUse of TENEX device for sectioning of the gluteus medius and ITB tendons.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 yearsSecondary 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.
Time frame
Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 yearsSponsors and contacts
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Source ClinicalTrials.gov