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

Cervical Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638074
• Other study ID #: 04.11.2022.1506
• Status: Recruiting
• Start date: November 28, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: November 2022
• Source: Marmara University
• Contact: janbubi jandaulyet, residency
• Phone: +905076755161
• Email: janbubi.jandaulyet[@]marmara.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Cervical Radicular Pain
• Hernia
• Intervertebral Disc Displacement

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Janbubi Jandaulyet

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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