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

NCT05638074 | Unknown DMC

• 1 other identifier: 04.11.2022.1506
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Disc Herniation; Cervical Radicular Pain; Facet Tropism

Keywords

facet tropism; cervical disc herniation; Cervical Radicular Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

With cervical facet tropism

Procedure: Interlaminar Epidural Steroid Injection

Without cervical facet tropism

Procedure: Interlaminar Epidural Steroid Injection

Interventions

Interlaminar Epidural Steroid Injection PROCEDURE

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.

With cervical facet tropism; Without cervical facet tropism

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to the pain medicine outpatient clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janbubi Jandaulyet: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 30603772 RESULT

Study Officials

• Osman Hakan Gunduz, Professor

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

janbubi jandaulyet, residency

CONTACT

+905076755161; janbubi.jandaulyet@marmara.edu.tr

savas sencan, Assosiate Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 6, 2022
• Study Start: November 28, 2022
• Primary Completion: May 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

TU (1)