Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection

Lumbar Radiculopathy Clinical Trial

Official title:

Comparison of Lateral Parasagittal Approach and Transforaminal Epidural Approach in Lumbar Epidural Steroid Injection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05551676
• Other study ID #: Lomber Epidural
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: December 22, 2023

Study information

• Verified date: September 2022
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. The purpose of the study is to determine which method is more efficient.

Description:

It was planned to recruit 60 participants in the study. Interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. All patients will receive Oswestry disability index before and 2-4-12 weeks after the procedure. All patients will receive Somatization Amplification Scale (SSAS) before the treatment. The results of the patients will be compared. It will be investigated which method is more effective.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unilateral low back pain, radiculopathy

Exclusion Criteria:

• malignancy

• past back surgery

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Procedure:
• transforaminal group
Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.
• Lateral parasagittal group
Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The SomatoSensory Amplification Scale	a 10-item self-report instrument designed to assess the tendency to detect somatic and visceral sensations and experience them as unusually intense, toxic and alarming.; 10: No symptom, 50: worst symptoms	Baseline
Primary	Oswestry disability index	Oswestry Low Back Pain Disability Questionnaire, the Oswestry Disability Index helps to measure a patient's lower back pain. It evaluates the extent to which the patient's level of function is restricted by the pain, concentrating on the effects rather than the nature of the pain.; 0% to 20%: minimal disability 41%-60%: severe disability 61%-80%: crippled	baseline, week 4, week 12