Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
29. september 2021 opdateret af: Micron Medical Corporation
Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
This is a prospective, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis PNS.
Subjects in the Delayed group will start with therapy at 3-month visit follow up.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective, randomized, controlled, multi-center study in which 300 evaluable subjects will receive Moventis PNS. Target subjects will have idiopathic hip pain.
Subjects will be randomized into either a delayed or immediate continuation group. Devices will be activated post-op in accordance to the randomization assignment. Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. Implanted subjects will be educated on the use of the transmitter. Programming changes can be done as needed during this time period to maximize clinical response according to pre-programmed settings. Subjects randomized to the Delayed group will begin 2-hour stimulation/day at the 3-Month visit.
The primary endpoint is to demonstrate clinically significant improvements in the pain of patients in the active group compared to the subjects in the delayed group. The primary endpoint is defined as >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications. Improvement will be assessed in relation to the clinical outcome measures of pain, with a target of >50% pain relief.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Shanice Saunders
- Telefonnummer: 888-691-0585
- E-mail: Contact@uromedical.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Capable of giving informed consent;
- Capable and willing to follow all study related procedures;
- Women and men >18 years of age;
- Diagnosis of hip pain;
- Baseline VAS score of >5;
- >50% temporary relief from temporary nerve diagnostic evaluation;
- No evidence of anatomic abnormalities that could jeopardize device placement;
- Able to operate programmer, recharger, study assessments and provide accurate responses;
- Appropriate candidate for the implant procedure.
Exclusion Criteria:
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Pregnant or plan to become pregnant during study;
- Less than 1-year post-partum and/or are breast-feeding;
- Symptoms existing for less than 6 months;
- Multiple complaints that will not be amenable to study;
- Current diagnosis of a Neurological disease;
- Daily opioid usage exceeding CDC recommendations;
- Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
- Conditions requiring recurring MRI evaluation or diathermy procedures;
- Uncontrolled diabetes (HbA1C > 8.5);
- Known or suspected substance abuse within the last 2-years;
- Uncontrolled major depression or uncontrolled psychiatric disorders;
- Worker's compensation claimants;
- History of adverse reaction to local anesthetic drugs;
- History of coagulopathy or bleeding disorder;
- Anatomical restrictions such that device placement is not possible;
- Chronic or acute conditions that could interfere with the interpretations of the outcome assessment for pain and bodily function;
- Have a life expectancy of less than 1-year;
- Neurogenic or vascular claudication;
- Inability to achieve appropriate positioning and inability to understand informed consent and protocol;
- Deemed unsuitable for enrollment by investigator based on history or physical examination.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Aktiv
Forsøgspersoner randomiseret til den aktive gruppe, programmeringsparametre vil blive indstillet, og terapi vil blive leveret i mindst 2 timer om dagen i hele undersøgelsens varighed.
|
Moventis PNS er indiceret til smertebehandling hos voksne, som har svære kroniske smerter af perifer nerveoprindelse.
|
|
Placebo komparator: Forsinket
Den forsinkede gruppe vil begynde 2-timers stimulation/dag ved 3-måneders besøget.
|
Moventis PNS er indiceret til smertebehandling hos voksne, som har svære kroniske smerter af perifer nerveoprindelse.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Tidsramme: 3 Months
|
Improvement pain defined as a >50% pain relief as measured by VAS without increase in baseline medications.
To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.
|
3 Months
|
|
Adverse Events
Tidsramme: 3 Months
|
Device- and procedure-related Adverse Events (AE) rate at 3-months.
|
3 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Hip Pain: measured by Hip Pain Questionnaire
Tidsramme: 3, 6, 9, 12, 24, 36-months
|
Current hip pain will be accessed and the history of hip pain will be recorded.
|
3, 6, 9, 12, 24, 36-months
|
|
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Tidsramme: 6, 9, 12, 24, 36-Months
|
Improvement pain defined as a >50% pain relief as measured by VAS without increase in baseline medications.
To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.
|
6, 9, 12, 24, 36-Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. november 2021
Primær færdiggørelse (Forventet)
1. juni 2023
Studieafslutning (Forventet)
1. juni 2024
Datoer for studieregistrering
Først indsendt
29. september 2021
Først indsendt, der opfyldte QC-kriterier
29. september 2021
Først opslået (Faktiske)
12. oktober 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TWIST 31-00105
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Upon study completion
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
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