Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

Not Applicable

Completed

Interventions: Procedure: Ultrasound guidance with fluoroscopic confirmation
Procedure: Fluoroscopic guidance with ultrasonographic confirmation.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ultrasound guidance with fluoroscopic confirmation	Ultrasound guidance with fluoroscopic confirmation	Patients in which the intervention will be performed using ultrasound guidance with fluoroscopic confirmation
Fluoroscopic guidance with ultrasonographic confirmation.	Fluoroscopic guidance with ultrasonographic confirmation.	Patients in which intervention will be performed using fluoroscopic guidance with ultrasonographic confirmation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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