Cervicobrachial Neuralgia
Conditions
Keywords
Neuropathic Cervicobrachial, Ultrasound-guided transforaminal infiltration, Cervical Interlaminar epidural infiltration, Cervical Chronic Pain
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.
Interventions
OTHERUltrasound-guided transforaminal epidural steroid injection
Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status (ASA) I-III * Chronic unilateral cervicobrachial pain * Allowed Steroid infiltration
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 Adverse effects (lipothymia, nausea, vomiting) | up to 1 month | — |
| Rate of Procedure failure | up to 30 minutes | The procedure will be considered as a failure if the infiltration is not performed. |
| Incidence of complications (stroke, hematoma, paralysis) | up to 1 month | — |
| 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. |
Countries
Belgium
Contacts
Primary ContactPanayota Kapessidou, MD,PhD
Backup ContactMohamed Ali Bali, MD
Outcome results
None listed