Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.
- Conditions
- Cervicobrachial Neuralgia
- Interventions
- Other: Interlaminar epidural steroid injectionOther: Ultrasound-guided transforaminal epidural steroid injection
- Registration Number
- NCT04475445
- Lead Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Brief Summary
Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- American Society of Anesthesiologists physical status (ASA) I-III
- Chronic unilateral cervicobrachial pain
- Allowed Steroid infiltration
- Pregnancy
- Lactation
- Allergy or intolerance to any of the drugs/materials used in this study,
- Participation in another interventional study
- Systemic anticoagulation,
- Infection at the puncture site
- Patient refusal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interlaminar epidural steroid injection Interlaminar epidural steroid injection - Ultrasound guided transforaminal epidural steroid injection Ultrasound-guided transforaminal epidural steroid injection -
- Primary Outcome Measures
Name Time Method Visual Analogue Score change at 30 minutes post infiltration when compared to baseline up to 30 minutes Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration.
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)
- Secondary Outcome Measures
Name Time Method Rate of Procedure failure up to 30 minutes The procedure will be considered as a failure if the infiltration is not performed.
Incidence of Adverse effects (lipothymia, nausea, vomiting) up to 1 month Visual Analogue Score change at 1 month post infiltration when compared to baseline up to 1 month Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after corticosteroid infiltration.
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)Neck disability index (NDI) score (questionnaire) up to 1 month Neck disability index (NDI) score will be calculated before, 30 minutes and 1 month after corticosteroid infiltration
The NDI is a standard instrument for measuring self-rated disability due to neck pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, Interpretation for scoring intervals : 0 - 4 = no disability; 5 - 14 = mild disability; 15 - 24 = moderate disability; 25 - 34 = severe disability, above 34 = complete disability.Patient satisfaction during procedure at the end of infiltration Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)
Incidence of complications (stroke, hematoma, paralysis) up to 1 month
Trial Locations
- Locations (1)
CHU Saint-Pierre
🇧🇪Bruxelles, Belgium