- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: David Curd
- Telefonní číslo: 314-480-2244
- E-mail: david.curd@brixtonbio.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Triamcinolone acetate
Corticosteroid injection
|
A single dose of Triamcinolone 40mg injected directly into the hip joint.
|
|
Experimentální: ReneuRx
|
ReneuRx will be injected around the trochanteric branches of the femoral nerve.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Primary Effectiveness
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Secondary Effectiveness
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 12 months post-treatment
|
Change in Timed-Up and Go (TUG) test scores
|
12 months post-treatment
|
|
Pain Relief
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Exploratory Endpoint
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BTX-786-GTPS-02
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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