Chronic Cervical Radicular Pain
Conditions
Brief summary
The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety during cervical transforaminal epidural injection of steroid and local anaesthetic The study will detect by which technique we have to start and confirm by the other to reach the favourable outcome.
Detailed description
In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7 seconds was reported. On the basis of these findings, a 30% difference in performance time would represent an effect size of 0.82 and would require 20 patients per group to achieve an alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total sample size of 64 patients (32 per group) will be required. Statistical Analysis: will be performed using SPSS version 22 statistical software. For quantitative data, normality will be first assessed with the Shapiro test and then analyzed with the Student t-test. Data that will not have a normal distribution, as well as ordinal data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test will be used. All P values presented will be 2-sided and values of less than 0.05 will be considered significant.
Interventions
PROCEDUREUltrasound guidance with fluoroscopic confirmation
the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
PROCEDUREFluoroscopic guidance with ultrasonographic confirmation.
After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced \ 3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering from radicular discogenic pain * Patients suffering from radicular foraminal pain Patients suffering from radicular pain secondary to spinal canal stenosis * Patients suffering from radicular pain after failed cervical disc surgery * Not responding to conservative management for at least 3 months * Patients with recalcitrant symptoms after transforaminal steroid injection. * American Society of Anesthesiology (ASA) from I to III
Exclusion criteria
* Presence of local or systemic infection * Coagulopathy * Body mass index \> 35 * Cervical spine fracture * Myelopathy * Malignancy * Pregnancy * Patients unable to communicate with the operator during the procedure or report their pain diary after it. * Patients not responding to previous cervical transforaminal steroid injection or had any untoward effects. * Allergy to any one of the used medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| performance time in minutes | starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes | Defined as time needed for correct transforaminal needle placement through ultrasound guidance followed by fluoroscopic confirmation or fluoroscopic guidance followed by ultrasound confirmation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of patient satisfaction | pre-procedure then every 3 months till 6 months after the procedure | Level of patient satisfaction (5-point scale); Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied |
| Feasibility of the radiologic target | starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes | number of needle corrections till confirmation of correct placement of the needle |
| Visual analogue score | pre-procedure then every 3 months till 6 months after the procedure | Visual analogue score (VAS, 11-point scale): using 100mm visual analogue score in which 0 mm represents no pain and 100mm worst pain imaginable |
| Neck disability index | pre-procedure then every 3 months till 6 months after the procedure | Neck disability index (NDI, 35-point scale); 0-4points (0-8%) no disability, 5-14points (10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability |
Countries
Egypt
Outcome results
None listed