Skip to main content
OpenTrials
Completed

NCT Number: NCT03792386

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enas A Abd el Motlb

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound guidance with fluoroscopic confirmation

Procedure

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.

Fluoroscopic guidance with ultrasonographic confirmation.

Procedure

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.

Primary outcomes

  1. performance time in minutes

    Time frame: 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 outcomes

  1. Feasibility of the radiologic target

    Time frame: 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

  2. Visual analogue score

    Time frame: 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

  3. Neck disability index

    Time frame: 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

  4. Level of patient satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Clinical Visibility of Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.