Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection
Comparison of Lateral Parasagittal Approach and Transforaminal Epidural Approach in Lumbar Epidural Steroid Injection
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2022
CompletedFirst Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2023
CompletedSeptember 23, 2022
September 1, 2022
1 year
August 29, 2022
September 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (1)
The SomatoSensory Amplification Scale
Baseline
Study Arms (2)
Transforaminal group
ACTIVE COMPARATORTransforaminal steroid injection will be applied, 30 patients
Lateral parasagittal group
ACTIVE COMPARATORLateral parasagittal steroid injection will be applied, 30 patients
Interventions
Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.
Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.
Eligibility Criteria
You may qualify if:
- Unilateral low back pain, radiculopathy
You may not qualify if:
- malignancy
- past back surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ömer Taylan AKKAYA
Diskapi TRH
- STUDY CHAIR
Hüseyin Alp Alptekin
Diskapi TRH
- PRINCIPAL INVESTIGATOR
Ezgi Can
Diskapi TRH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 29, 2022
First Posted
September 23, 2022
Study Start
June 22, 2022
Primary Completion
June 22, 2023
Study Completion
December 22, 2023
Last Updated
September 23, 2022
Record last verified: 2022-09