Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

Mansoura University

Status: Completed

Conditions: Chronic Cervical Radicular Pain

Treatments: Procedure: Fluoroscopic guidance with ultrasonographic confirmation.; Procedure: Ultrasound guidance with fluoroscopic confirmation

Study type: Interventional

Funder types: Other

Identifiers

NCT03792386

R/17.06.52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Ultrasound guidance with fluoroscopic confirmation

Active Comparator group

Description:

Patients in which the intervention will be performed using ultrasound guidance with fluoroscopic confirmation

Treatment:

Procedure: Ultrasound guidance with fluoroscopic confirmation

Fluoroscopic guidance with ultrasonographic confirmation.

Active Comparator group

Description:

Patients in which intervention will be performed using fluoroscopic guidance with ultrasonographic confirmation.

Treatment:

Procedure: Fluoroscopic guidance with ultrasonographic confirmation.