CRIS Based Evaluation of Cervical Interlaminar Epidural Steroid Injection Outcomes
Simultaneous Evaluation Neck and Arm Symptoms Using the Cervical Radiculopathy ımpact Scale: A Prospective Study on the Efficacy of Cervical Interlaminar Epidural Steroid Injection
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ankara, Türkei (türkiye)
- University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Cervical Radiculopathy Impact Scale (CRIS) Score
Zeitfenster: Baseline to 3 months
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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
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Baseline to 3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Numeric Rating Scale (NRS) Score
Zeitfenster: Baseline to 3 months
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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
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Baseline to 3 months
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Neck Disability Index (NDI) Score
Zeitfenster: Baseline to 3 months
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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
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Baseline to 3 months
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Change in QuickDASH Score
Zeitfenster: Baseline to 3 months
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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
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Baseline to 3 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Alp Eren Celenlioglu, MD, Assoc. Prof, University of Health Sciences Gulhane Training and Research Hospital, Department of Algology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GEAH-ALGO-CRIS-4
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