Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections?

Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections? A Prospective Clinical Study

Facet joints are synovial joints located on the dorsolateral side of the vertebral column. Normally, both facet joints are symmetrical. Facet tropism (FT) is defined as asymmetry between the angles of orientation of the joints, in which a facet joint in the same segment is more sagittally oriented than the other. In 1967, Farfan and Sullivan first reported that FT is a possible risk factor for the development of disk herniation. However, this is controversial as there are other views advocating that FT is not a risk factor for the development of cervical disc herniation. Further, it has been emphasized that patients with FT have a greater need for adjacent segment degeneration and new spinal surgery after spinal fusion surgeries than those without FT.

In the current literature, studies have been conducted to examine the clinical and radiological parameters that may be related to the effectiveness of cervical interlaminar epidural steroid injections (ILESI). The aim of this study was to examine the effect of the presence of FT on ILESI results in patients with cervical disc herniation-induced radicular pain.

Study Overview

• Status: Recruiting
• Conditions: Cervical Disc Herniation; Cervical Radicular Pain; Facet Tropism
• Intervention / Treatment: Procedure: Interlaminar Epidural Steroid Injection

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: janbubi jandaulyet, residency; Phone Number: +905076755161; Email: janbubi.jandaulyet@marmara.edu.tr
• Study Contact Backup: Name: savas sencan, Assosiate Professor

Study Locations

• Turkey
  • Pendik
    • Istanbul, Pendik, Turkey, 34899
      • Recruiting
      • Marmara University Pendik Training and Research Hospital
      • Contact: janbubi jandaulyet; Phone Number: +905076755161; Email: janbubi.jandaulyet@marmara.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to the pain medicine outpatient clinic

Description

Inclusion Criteria:

aged 18-75 years, who applied to the pain medicine outpatient clinic, had axial neck and unilateral radicular extremity pain for at least 3 months, and were diagnosed with protruded disc herniation by magnetic resonance imaging were included in the study

Exclusion Criteria:

Patients with systemic inflammatory disease, bleeding diathesis,history of psychiatric illness, malignancy, contrast material or local anesthetic agent allergy, cervical spinal stenosis, history of cervical ESI, or neck surgery in the last 3 months were excluded from the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With cervical facet tropism	Procedure: Interlaminar Epidural Steroid Injection; The patient will be placed in the prone position and cutaneous anesthesia is performed with 3 mL of 2% prilocaine using the sterile technique. After imaging the C7-T1 space with fluoroscopy, it will be entered from the right/left paramedian part of the C7-T1 space with an 18G Touhy needle, and the C-arm will be set in the contralateral oblique position for depth determination. Under intermittent fluoroscopic imaging, the needle will be advanced, and access to the epidural space wiil be confirmed by the loss of resistance technique. Afterwards, the epidural spread will be controlled with a contrast agent, and a mixture of 10 mg dexamethasone, 1 mL 2% lidocaine hydrochloride, and 1 mL 0.9% saline will be applied to the epidural space. The patient will be discharged with recommendations after being kept under observation for 2 hours post-procedure. All injections will be performed by the same pain medicine specialist who has at least 5 years of experience.
Without cervical facet tropism	Procedure: Interlaminar Epidural Steroid Injection; The patient will be placed in the prone position and cutaneous anesthesia is performed with 3 mL of 2% prilocaine using the sterile technique. After imaging the C7-T1 space with fluoroscopy, it will be entered from the right/left paramedian part of the C7-T1 space with an 18G Touhy needle, and the C-arm will be set in the contralateral oblique position for depth determination. Under intermittent fluoroscopic imaging, the needle will be advanced, and access to the epidural space wiil be confirmed by the loss of resistance technique. Afterwards, the epidural spread will be controlled with a contrast agent, and a mixture of 10 mg dexamethasone, 1 mL 2% lidocaine hydrochloride, and 1 mL 0.9% saline will be applied to the epidural space. The patient will be discharged with recommendations after being kept under observation for 2 hours post-procedure. All injections will be performed by the same pain medicine specialist who has at least 5 years of experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS score	≥50% reduction in the NRS scores at month 3 relative to the initial NRS scores.	at first hour, at three weeks, at 3 months

Collaborators and Investigators

• Sponsor: Janbubi Jandaulyet
• Investigators: Study Director: Osman Hakan Gunduz, Professor, Marmara University

Publications and helpful links

General Publications

• Celenlioglu AE, Sencan S, Gunduz OH. Does facet tropism negatively affect the response to transforaminal epidural steroid injections? A prospective clinical study. Skeletal Radiol. 2019 Jul;48(7):1051-1058. doi: 10.1007/s00256-018-3129-8. Epub 2019 Jan 2.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 28, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: facet tropism; cervical disc herniation; Cervical Radicular Pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 04.11.2022.1506

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
• product manufactured in and exported from the U.S.: No