- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07568015
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain (RENEU)
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain: A Multi-Center, Randomized, Controlled Trial (RENEU)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: David Curd
- Numer telefonu: 314-480-2244
- E-mail: david.curd@brixtonbio.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Age 22 to 80, inclusive of any gender
- Baseline pain intensity of >5 of the Numeric Rating Scale (NRS) localized to the lateral aspect of the hip (with or without radiation to lateral thigh or buttock) despite current treatment
- Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.
- At least 6 months of previous conservative treatments for subject's lateral hip pain (NSAID, acetaminophen, physical therapy, and/or cortisone injections) that are not currently providing relief
- Agree to see study investigator and study team for hip pain during the study period
- Willing/able to understand the informed consent form and provide written informed consent
- Able to complete outcome measures (including electronic patient reported outcome measures)
Exclusion Criteria:
- Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
- History of cryoglobulinemia
- History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
- History of cold urticaria
- History of Chilblain's (pernio) disease in the lower extremities
- History of Raynaud's disease
- Open and/or infected wounds or active tumor at or near the treatment site
- History of vascular surgery involving femoral vessels on theinjection side
- History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)
- History of trochanteric osteotomy, femoral osteotomy, or amputation
- Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation
- Currently taking >60 MME/day
- History of systemic inflammatory conditions such as rheumatoid arthritis
- Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion
- Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain
- Presence of unstable psychiatric disease
- Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index hip(s) within the past 12 months
- Corticosteroid injection within the previous 3 months or orthobiologic therapy such as platelet rich plasma injections for the index hip(s) within the previous 6 months
- Known contraindication to use of a regional anesthetic block
- Pregnant, nursing, or intent of becoming pregnant during the study period
- Documented evidence of an overlapping pain pattern from another source that the Investigator believes to be indistinguishable from lateral hip pain
- Lumbar or sacroiliac fusion within the previous 6 months
- Any other condition (such as history of deep vein thrombosis, significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition including cancer) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
- Body habitus/hip anatomy that would preclude the use of the product injection needle size
- Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
- Pending litigation or disability status
- Unwilling to refrain from any scheduled surgeries that would impact the collection of study endpoint data during the duration of the study
- Subject is a prisoner
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Triamcinolone acetate
Corticosteroid injection
|
A single dose of Triamcinolone 40mg injected directly into the hip joint.
|
|
Eksperymentalny: ReneuRx
|
ReneuRx will be injected around the trochanteric branches of the femoral nerve.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Primary Effectiveness
Ramy czasowe: 3-months post treatment
|
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
|
3-months post treatment
|
|
Primary Safety
Ramy czasowe: Through study completion, an average of 12-months
|
Aggregate serious device-related adverse events through final follow-up visit
|
Through study completion, an average of 12-months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Secondary Effectiveness
Ramy czasowe: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
|
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.
|
Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
|
|
Secondary Effectiveness
Ramy czasowe: 3 month and 6 month post-treatment
|
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".
|
3 month and 6 month post-treatment
|
|
Secondary Effectiveness
Ramy czasowe: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
|
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.
|
Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
|
|
Secondary Effectiveness
Ramy czasowe: 12 months post-treatment
|
Change in Timed-Up and Go (TUG) test scores
|
12 months post-treatment
|
|
Pain Relief
Ramy czasowe: 6-Month, 12-Month
|
Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline.
|
6-Month, 12-Month
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Exploratory Endpoint
Ramy czasowe: 12 months post-treatment
|
Patient Specific Functional Scale (PSFS) The Patient-Specific Functional Scale (PSFS) assesses a subject's functional ability to complete an activity. Activities will be rated on an 11-point scale (0-10), where 0 indicates "unable to perform activity" and 10 indicates "able to perform activity at the same level as before injury or problem." The activities will be chosen and approved by both the subject and investigator. |
12 months post-treatment
|
|
Exploratory Endpoints
Ramy czasowe: 12 months post-treatment
|
Patient-Reported Outcome Measurement Information System (PROMIS) 29 score The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. |
12 months post-treatment
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BTX-786-GTPS-02
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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