Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

Clinical Visibility of Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

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.

Study Overview

• Status: Completed
• Conditions: Chronic Cervical Radicular Pain
• Intervention / Treatment: Procedure: Ultrasound guidance with fluoroscopic confirmation; Procedure: Fluoroscopic guidance with ultrasonographic confirmation.

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Enas A Abd el Motlb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guidance with fluoroscopic confirmation; Patients in which the intervention will be performed using ultrasound guidance with fluoroscopic confirmation	Procedure: Ultrasound 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.
Active Comparator: Fluoroscopic guidance with ultrasonographic confirmation.; Patients in which intervention will be performed using fluoroscopic guidance with ultrasonographic confirmation.	Procedure: Fluoroscopic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
performance time in minutes	Defined as time needed for correct transforaminal needle placement through ultrasound guidance followed by fluoroscopic confirmation or fluoroscopic guidance followed by ultrasound confirmation	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the radiologic target	number of needle corrections till confirmation of correct placement of the needle	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
Visual analogue score	Visual analogue score (VAS, 11-point scale): using 100mm visual analogue score in which 0 mm represents no pain and 100mm worst pain imaginable	pre-procedure then every 3 months till 6 months after the procedure
Neck disability index	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	pre-procedure then every 3 months till 6 months after the procedure
Level of patient satisfaction	Level of patient satisfaction (5-point scale); Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied	pre-procedure then every 3 months till 6 months after the procedure

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: R/17.06.52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No