- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: David Curd
- Telefonnummer: 314-480-2244
- E-post: david.curd@brixtonbio.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Triamcinolone acetate
Corticosteroid injection
|
A single dose of Triamcinolone 40mg injected directly into the hip joint.
|
|
Experimentell: ReneuRx
|
ReneuRx will be injected around the trochanteric branches of the femoral nerve.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Effectiveness
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Secondary Effectiveness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12 months post-treatment
|
Change in Timed-Up and Go (TUG) test scores
|
12 months post-treatment
|
|
Pain Relief
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exploratory Endpoint
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BTX-786-GTPS-02
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