Clinical trial NCT03792386: Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection
Official title: Clinical Visibility of Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cervical Radicular Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: performance time in minutes
timeFrame: 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
Secondary outcomes:
measure: Feasibility of the radiologic target
timeFrame: 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
measure: Visual analogue score
timeFrame: pre-procedure then every 3 months till 6 months after the procedure
measure: Neck disability index
timeFrame: pre-procedure then every 3 months till 6 months after the procedure
measure: Level of patient satisfaction
timeFrame: pre-procedure then every 3 months till 6 months after the procedure
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Enas A Abd el Motlb
state: DK
Study officials:
affiliation: Associate Professor
name: Enas A Abd el Motlb, MD
role: STUDY_CHAIR
References: