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Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection

Primary Purpose

Lumbar Radiculopathy

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transforaminal group
Lateral parasagittal group
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring epidural steroid injection, transforaminal steroid injection, radicular pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral low back pain, radiculopathy

Exclusion Criteria:

  • malignancy
  • past back surgery

Sites / Locations

  • Diskapi Yildirim Beyazıt Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transforaminal group

Lateral parasagittal group

Arm Description

Transforaminal steroid injection will be applied, 30 patients

Lateral parasagittal steroid injection will be applied, 30 patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2022
Last Updated
September 21, 2022
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05551676
Brief Title
Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection
Official Title
Comparison of Lateral Parasagittal Approach and Transforaminal Epidural Approach in Lumbar Epidural Steroid Injection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
June 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
epidural steroid injection, transforaminal steroid injection, radicular pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transforaminal group
Arm Type
Active Comparator
Arm Description
Transforaminal steroid injection will be applied, 30 patients
Arm Title
Lateral parasagittal group
Arm Type
Active Comparator
Arm Description
Lateral parasagittal steroid injection will be applied, 30 patients
Intervention Type
Procedure
Intervention Name(s)
transforaminal group
Intervention Description
Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.
Intervention Type
Procedure
Intervention Name(s)
Lateral parasagittal group
Intervention Description
Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
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
Time Frame
baseline, week 4, week 12
Other Pre-specified Outcome Measures:
Title
The SomatoSensory Amplification Scale
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral low back pain, radiculopathy Exclusion Criteria: malignancy past back surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Taylan AKKAYA
Organizational Affiliation
Diskapi TRH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hüseyin Alp Alptekin
Organizational Affiliation
Diskapi TRH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ezgi Can
Organizational Affiliation
Diskapi TRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazıt Teaching and Research Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection

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