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

NCT ID: NCT05638074

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-28

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Disc Herniation Cervical Radicular Pain Facet Tropism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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With cervical facet tropism

Interlaminar Epidural Steroid Injection

Intervention Type 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.

Without cervical facet tropism

Interlaminar Epidural Steroid Injection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janbubi Jandaulyet

OTHER

Sponsor Role lead

Responsible Party

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Janbubi Jandaulyet

Resident Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Osman Hakan Gunduz, Professor

Role: STUDY_DIRECTOR

Marmara University

Locations

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Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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janbubi jandaulyet, residency

Role: CONTACT

+905076755161

savas sencan, Assosiate Professor

Role: CONTACT

Facility Contacts

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janbubi jandaulyet

Role: primary

+905076755161

References

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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.

Reference Type RESULT
PMID: 30603772 (View on PubMed)

Other Identifiers

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04.11.2022.1506

Identifier Type: -

Identifier Source: org_study_id

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