Clinical trial NCT05638074: Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections?
Official title: Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections? A Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Disc Herniation
Cervical Radicular Pain
Facet Tropism
Keywords: facet tropism
cervical disc herniation
Cervical Radicular Pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who applied to the pain medicine outpatient clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: NRS score
timeFrame: at first hour, at three weeks, at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: Pendik
Study officials:
affiliation: Marmara University
name: Osman Hakan Gunduz, Professor
role: STUDY_DIRECTOR
References:
citation: 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.