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CRIS Based Evaluation of Cervical Interlaminar Epidural Steroid Injection Outcomes

9. juni 2026 opdateret af: Saglik Bilimleri Universitesi

Simultaneous Evaluation Neck and Arm Symptoms Using the Cervical Radiculopathy ımpact Scale: A Prospective Study on the Efficacy of Cervical Interlaminar Epidural Steroid Injection

This prospective single-center study aims to evaluate the clinical efficacy of fluoroscopy-guided cervical interlaminar epidural steroid injection (CIESI) in patients with unilateral, single-level cervical radiculopathy due to cervical disc herniation. Unlike previous studies that assessed neck and arm symptoms separately, this study uses the Cervical Radiculopathy Impact Scale (CRIS) as the primary outcome measure to simultaneously evaluate cervical and upper extremity symptoms and their functional impact. A total of 98 patients resistant to conservative treatment will be assessed at baseline, 3 weeks, and 3 months after CIESI using CRIS, Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH scores. The primary outcome is improvement in CRIS scores following the intervention, while secondary outcomes include changes in pain intensity and functional disability. The study seeks to determine whether CRIS provides a more comprehensive and clinically meaningful assessment of treatment response in cervical radiculopathy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective single-center study evaluates the effectiveness of fluoroscopy-guided cervical interlaminar epidural steroid injection (CIESI) in patients with unilateral, single-level cervical radiculopathy caused by cervical disc herniation and resistant to conservative treatment. The study particularly focuses on the simultaneous assessment of neck and upper extremity symptoms using the Cervical Radiculopathy Impact Scale (CRIS), a multidimensional patient-reported outcome measure.

Patients meeting the eligibility criteria undergo CIESI using a parasagittal interlaminar approach under fluoroscopic guidance. Clinical evaluations are performed before the procedure and repeated at 3 weeks and 3 months after treatment. Outcome measures include CRIS, Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH scores.

The primary objective is to determine the change in CRIS scores following CIESI. Secondary objectives include evaluating changes in pain severity, neck disability, and upper extremity function after the intervention. The study also investigates the relationship between CRIS improvement and changes in conventional outcome measures to assess the responsiveness and clinical utility of CRIS in cervical radiculopathy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye)
        • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010

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: Age between 18 and 65 years Unilateral single-level cervical disc herniation confirmed by cervical MRI Cervical radicular pain associated with neck pain persisting for at least 6 months Symptoms refractory to conservative treatment, including oral medications and physical therapy Baseline Numeric Rating Scale (NRS) score ≥6 Undergoing fluoroscopy-guided cervical interlaminar epidural steroid injection Ability to complete study questionnaires and attend follow-up visits Written informed consent provided by the participant

Exclusion Criteria:Multilevel cervical disc disease Advanced cervical spinal stenosis Previous cervical spine surgery Cervical epidural steroid injection within the previous 6 months Incomplete procedure due to vasovagal reaction or technical failure Incomplete clinical records or unavailable cervical MRI data Inability to complete follow-up assessments or questionnaires Refusal to provide informed consent

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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: Cervical Interlaminar Epidural Steroid Injection
Patients with unilateral, single-level cervical radiculopathy due to cervical disc herniation underwent fluoroscopy-guided cervical interlaminar epidural steroid injection using a parasagittal approach. Clinical outcomes were evaluated at baseline, 3 weeks, and 3 months using the Cervical Radiculopathy Impact Scale (CRIS), Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH.
Procedure: Cervical Interlaminar Epidural Steroid Injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection was performed at the C7-T1 level using a parasagittal approach. After confirmation of epidural spread with contrast medium under contralateral oblique imaging, a total of 6 mL solution containing dexamethasone, lidocaine, and normal saline was injected into the epidural space. All procedures were performed by an experienced pain specialist, and patients were monitored for possible complications after the procedure.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cervical Radiculopathy Impact Scale (CRIS) Score
Tidsramme: Baseline to 3 months
The Cervical Radiculopathy Impact Scale (CRIS) was used to evaluate changes in neck and upper extremity symptoms and related functional disability following cervical interlaminar epidural steroid injection. Higher scores indicate greater disability and symptom burden. Min-max score: 21/105
Baseline to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Numeric Rating Scale (NRS) Score
Tidsramme: Baseline to 3 months
The Numeric Rating Scale (NRS) was used to assess pain intensity before and after cervical interlaminar epidural steroid injection. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity. Min-max score: 0/10
Baseline to 3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Neck Disability Index (NDI) Score
Tidsramme: Baseline to 3 months
The Neck Disability Index (NDI) was used to assess changes in neck-related functional disability following cervical interlaminar epidural steroid injection. Higher scores indicate greater disability. min-max score: 0/50
Baseline to 3 months
Change in QuickDASH Score
Tidsramme: Baseline to 3 months
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire was used to evaluate changes in upper extremity function and symptoms following cervical interlaminar epidural steroid injection. Higher scores indicate greater disability. Min-max score: 0-100
Baseline to 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Saglik Bilimleri Universitesi

Efterforskere

  • Studieleder: Alp Eren Celenlioglu, MD, Assoc. Prof, University of Health Sciences Gulhane Training and Research Hospital, Department of Algology

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. september 2024

Primær færdiggørelse (Faktiske)

15. juli 2025

Studieafslutning (Faktiske)

15. juli 2025

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GEAH-ALGO-CRIS-4

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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