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Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain

4. juni 2026 opdateret af: EPC Education s.r.o.

Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study

Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation (BVNA) for Axial Low Back Pain treatment, including the method optimization.

Description of Clinical State:

The basivertebral nerve is a small nerve (or rather a nerve fiber) located within the vertebral bodies, responsible for transmitting pain signals from a degenerated disc. Basivertebral nerve ablation is a minimally invasive procedure consisting of the interruption of the basivertebral nerve fibers that conduct pain.

Description of interventional procedures:

The BVNA procedure is performed under sterile conditions in an interventional suite by an experienced physician under fluoroscopic (X-ray) guidance. Following local anesthesia of the skin and subcutaneous tissue, a working instrument (cannula) is inserted into the affected vertebral body, guided by the patient's individual anatomy and preoperative Magnetic Resonance Imaging (MRI) planning. Subsequently, a radiofrequency electrode is introduced into the central part of the vertebral body. Through this electrode, targeted thermal energy is applied, leading to the interruption of pain signal transmission from the basivertebral nerve. Both the temperature and the duration of the application are strictly controlled. The patient remains conscious or under light sedation throughout the procedure and is continuously monitored and questioned regarding any discomfort, particularly pain or sensations of heat. Upon completion of the procedure, the electrode and the working instrument are removed, the puncture site is treated with a sterile dressing, and the patient is typically discharged to home care after a brief postoperative observation period. During the follow-up period, the patient will be asked to complete standardized questionnaires (Numeric Rating Scale (NRS) for Pain; Pain, Enjoyment of Life, and General Activity (PEG) Assessment; Global Rating of Change (GRC); The Oswestry Disability Index (ODI); EQ-5D Standardized Questionnaire used to measure Health-related Quality of Life) assessing pain intensity, functional limitations, and quality of life at intervals of 6 weeks, and 3, 6, and 12 months post-procedure, and long-term (24 months and beyond) depending on capacity. The follow-up also includes a control MRI scan approximately 6 months after the procedure.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Slovakiet
      • Košice, Slovakiet, 04001
        • Ikke rekrutterer endnu
        • Poliklinika Terasa
        • Kontakt:
  • Sverige
      • Umeå, Sverige, 90137
        • Ikke rekrutterer endnu
        • Europainclinics Sweden
        • Kontakt:
  • Tjekkiet
      • Prague, Tjekkiet, 17000
        • Rekruttering
        • EuroPainClinics Praha a.s
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Axial low back pain (with or without lateral component).
  • Presence of Modic type I or II changes at ≥ 1 level.
  • Age over 18 years.
  • Duration of pain ≥ 6 months.
  • Completion of full conservative management for ≥ 3 months.

Exclusion Criteria:

  • Coagulation disorders.
  • Platelet abnormalities.
  • Lack of informed consent.
  • Generalized solid tumor.
  • Hematopoietic malignancy.
  • Radicular pain.
  • Alternative primary pain generators other than axial low back pain.
  • Previous spinal surgery.
  • Targeted level located above L3/L4
  • Osteoporosis

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BVN ablation
Procedure: BVN ablation
intraosseal monopolar basivertebral nerve ablation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Oswestry Disability Index (ODI)
Tidsramme: 6 weeks, and 3, 6, 12 months
Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
6 weeks, and 3, 6, 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numeric Rating Scale (NRS) for Pain
Tidsramme: 6 weeks, and 3,6,12 months
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
6 weeks, and 3,6,12 months
EQ-5D standardized questionnaire used to measure health-related quality of life
Tidsramme: 6 weeks, and 3, 6 12 months
Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
6 weeks, and 3, 6 12 months
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Tidsramme: 6 weeks, and 3, 6 12 months
Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
6 weeks, and 3, 6 12 months
Global Rating of Change (GRC)
Tidsramme: 6 weeks, and 3, 6 12 months
retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
6 weeks, and 3, 6 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

EPC Education s.r.o.

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 (Faktiske)

4. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • KS_EPCcz_2026/001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kroniske rygsmerter

Kliniske forsøg med BVN ablation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Qatar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner