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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ankara, Turchia (Türkiye)
- University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Cervical Radiculopathy Impact Scale (CRIS) Score
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Numeric Rating Scale (NRS) Score
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Neck Disability Index (NDI) Score
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Alp Eren Celenlioglu, MD, Assoc. Prof, University of Health Sciences Gulhane Training and Research Hospital, Department of Algology
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GEAH-ALGO-CRIS-4
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