The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires. Participants will be followed for approximately 6-12 months after the study procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
A single 40mg Triamcinolone dose, prepared as 1ml of steroid mixed with 4ml of saline, of which 3-5ml is injected.
ReneuRx will be injected around the trochanteric branches of the femoral nerve.
Healthcare Outcomes Performance Company
Sun City, Arizona, United States
RECRUITINGEmory Orthopedics and Spine Center
Johns Creek, Georgia, United States
NOT_YET_RECRUITINGOchsner Health Center
New Orleans, Louisiana, United States
NOT_YET_RECRUITINGSkylight Health Research
Burlington, Massachusetts, United States
NOT_YET_RECRUITINGMass General Brigham
Chestnut Hill, Massachusetts, United States
NOT_YET_RECRUITINGVirtua Health
Sewell, New Jersey, United States
NOT_YET_RECRUITINGThe Orthopaedic Center
Tulsa, Oklahoma, United States
RECRUITINGRothman Orthopaedics
King of Prussia, Pennsylvania, United States
RECRUITINGPain Diagnostics & Interventional Care
Sewickley, Pennsylvania, United States
RECRUITINGUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
NOT_YET_RECRUITING...and 1 more locations
Primary Effectiveness
The primary endpoint of this study is the proportion of subjects whose hip pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment
Time frame: 3-months post treatment
Primary Safety
Aggregate serious device-related adverse events through final follow-up visit
Time frame: Through study completion, an average of 12-months
Secondary Effectiveness
Numeric Rating Scales - The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. With 0 being no pain and 10 being the most pain.
Time frame: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness
Patient Global Impressions Scale (PGIC) The Patient Global Impression of Change (PGIC) score is a self-reported measure used to assess a patient's perception of their overall improvement or worsening in health status following a specific treatment. It is often used in clinical trials and research studies to gauge the efficacy of interventions from the patient's perspective. The PGIC typically ranges from "very much worse" to "very much improved".
Time frame: 3 month and 6 month post-treatment
Secondary Effectiveness
VISA-G (Victorian Institute of Sports Assessment-Gluteal Score) The Victorian Institute of Sport Assessment (VISA-) Gluteal (G) Questionnaire is a self-report clinical outcome measure used in patients with greater trochanteric pain syndrome (GTPS). It consists of eight questions that measure the domains of pain, function in daily living, and sports activities The VISA-G can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.
Time frame: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness
Change in Timed-Up and Go (TUG) test scores
Time frame: 12 months post-treatment
Pain Relief
Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline.
Time frame: 6-Month, 12-Month
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