Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05551676

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Radiculopathy	Procedure: transforaminal group Procedure: Lateral parasagittal group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 22, 2022

Anticipated Primary Completion Date :

Jun 22, 2023

Anticipated Study Completion Date :

Dec 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transforaminal group Transforaminal steroid injection will be applied, 30 patients	Procedure: transforaminal group Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.
Active Comparator: Lateral parasagittal group Lateral parasagittal steroid injection will be applied, 30 patients	Procedure: Lateral parasagittal group Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.

Arm

Intervention/Treatment

Active Comparator: Transforaminal group

Transforaminal steroid injection will be applied, 30 patients

Procedure: transforaminal group

Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.

Active Comparator: Lateral parasagittal group

Lateral parasagittal steroid injection will be applied, 30 patients

Procedure: Lateral parasagittal group

Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.

Outcome Measures

Primary Outcome Measures

Oswestry disability index [baseline, week 4, week 12]
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

Other Outcome Measures

The SomatoSensory Amplification Scale [Baseline]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unilateral low back pain, radiculopathy

Exclusion Criteria:

malignancy
past back surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diskapi Yildirim Beyazıt Teaching and Research Hospital	Ankara		Turkey

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

Study Director: Ömer Taylan AKKAYA, Diskapi TRH
Study Chair: Hüseyin Alp Alptekin, Diskapi TRH
Principal Investigator: Ezgi Can, Diskapi TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Damla Yürük, Director, Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT05551676

Other Study ID Numbers:

Lomber Epidural

First Posted:

Sep 23, 2022

Last Update Posted:

Sep 23, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Damla Yürük, Director, Diskapi Teaching and Research Hospital

epidural steroid injection

transforaminal steroid injection

radicular pain

Additional relevant MeSH terms:

Radiculopathy

Study Results

No Results Posted as of Sep 23, 2022