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Ultrasound-Guided Proximal Superior Cluneal Nerve Block for Superior Cluneal Nerve Entrapment (PRO-SCN)

14. juli 2026 opdateret af: Gaziosmanpasa Research and Education Hospital

Clinical Outcomes of Ultrasound-Guided Proximal Superior Cluneal Nerve Block in Patients With Superior Cluneal Nerve Entrapment

Superior cluneal nerve entrapment (SCNE) is an underrecognized cause of chronic low back pain and gluteal pain that may mimic lumbar spine disorders. Ultrasound-guided proximal superior cluneal nerve block has increasingly been used in routine clinical practice .Diagnostic superior cluneal nerve block is commonly used to confirm the diagnosis, whereas ultrasound-guided proximal superior cluneal nerve block has emerged as a therapeutic option.

This prospective observational cohort study aims to evaluate the clinical outcomes of ultrasound-guided proximal superior cluneal nerve block in patients with clinically diagnosed superior cluneal nerve entrapment who undergo the procedure as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be assessed at baseline and during follow-up to evaluate treatment outcomes.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Superior cluneal nerve entrapment (SCNE) is an increasingly recognized cause of chronic low back pain that may be overlooked or misdiagnosed as lumbar radiculopathy or other degenerative lumbar disorders. Accurate diagnosis is essential because patients with SCNE may benefit from targeted peripheral nerve interventions rather than treatments directed at the lumbar spine.

Ultrasound-guided proximal superior cluneal nerve block has emerged as a practical technique for both diagnostic confirmation and therapeutic management of SCNE. Compared with landmark-based approaches, ultrasound guidance enables real-time visualization of relevant anatomical structures and standardized needle placement. Despite increasing clinical use, prospective evidence evaluating the clinical outcomes of this technique remains limited.

This prospective observational cohort study will enroll patients with clinically diagnosed superior cluneal nerve entrapment who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be evaluated at baseline and at 1- and 3-month follow-up visits using validated clinical outcome measures.

The primary objective is to evaluate changes in pain intensity following ultrasound-guided proximal superior cluneal nerve block. Secondary objectives include evaluating changes in disability and neuropathic pain characteristics after treatment and documenting the clinical outcomes of this intervention during routine practice.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

40

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Gaziosmanpaşa, Istanbul, Tyrkiet (Türkiye), 34255
        • Rekruttering
        • Gaziosmanpasa Research and Education Hospital
        • 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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults with chronic low back and/or gluteal pain and a positive diagnostic superior cluneal nerve block response who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will be prospectively followed for clinical outcomes.

Beskrivelse

Inclusion Criteria:

  • Age 18-75 years.
  • Chronic low back and/or gluteal pain persisting for at least 3 months.
  • Localized pain and/or tenderness over the posterior iliac crest.
  • At least 50% reduction in pain intensity following diagnostic superior cluneal nerve block.
  • Failure of conservative treatment.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Previous superior cluneal nerve surgery.
  • Active local or systemic infection.
  • Bleeding disorders or contraindications to the procedure.
  • Allergy to study medications.
  • Pregnancy.
  • Severe cognitive impairment or inability to complete study assessments.
  • Additional interventional pain procedures involving the affected region during follow-up.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients With Superior Cluneal Nerve Entrapment Undergoing Ultrasound-Guided Proximal Superior Clune
Adults with clinically diagnosed superior cluneal nerve entrapment undergoing ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will undergo baseline clinical assessment followed by follow-up evaluations at 1 and 3 months.
Procedure: Ultrasound-Guided Proximal Superior Cluneal Nerve Block
Ultrasound-guided proximal superior cluneal nerve block will be performed as part of routine clinical care in patients with clinically diagnosed superior cluneal nerve entrapment. The proximal superior cluneal nerve will be targeted using a standardized ultrasound-guided interfascial technique. A standardized injectate will be administered according to the study protocol. All procedures will be performed by an experienced pain physician using the same technique for all participants.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity
Tidsramme: Baseline, 1 month, and 3 months
Change in Numeric Rating Scale (NRS) pain score following ultrasound-guided proximal superior cluneal nerve block.
Baseline, 1 month, and 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Oswestry Disability Index (ODI) Score
Tidsramme: Baseline, 1 month, and 3 months
Change in Oswestry Disability Index (ODI) score from baseline following ultrasound-guided proximal superior cluneal nerve block.
Baseline, 1 month, and 3 months
Douleur Neuropathique 4 (DN4)
Tidsramme: Baseline, 1 month, and 3 months
Change in DN4 score.
Baseline, 1 month, and 3 months
Treatment Response
Tidsramme: 1 month and 3 months
Treatment response will be defined as a ≥50% reduction in NRS pain score compared with baseline.
1 month and 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Gaziosmanpasa Research and Education Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

15. maj 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • MEDIPOL-EC-846-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The investigators have not yet made a final decision regarding individual participant data (IPD) sharing. Data sharing will be considered after study completion in accordance with institutional policies, ethical requirements, and applicable data protection regulations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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