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UnknownNCT05638074

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

Status
Unknown
Phase
Study type
Observational
Enrollment
90 (estimated)
Sponsor
Janbubi Jandaulyet · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREInterlaminar Epidural Steroid InjectionThe 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.

Timeline

Start date
2022-11-28
Primary completion
2023-05-30
Completion
2023-08-30
First posted
2022-12-06
Last updated
2022-12-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05638074. Inclusion in this directory is not an endorsement.