Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.

Detailed Description
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Participants were randomly allocated to receive either parasagittal interlaminar or transforaminal ESI. Investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (NIC) and degree of depression. Depression was assessed by the Korean version of the Beck Depression Inventory (BDI). The BDI is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. All data were obtained before performing ESI.Data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal ESI. Also total procedure time and amount of radiation exposure were checked. Investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. The participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location. Investigators used the numerical rating scale (NRS) as well as the Korean version of the Oswestry Disability Index (ODI) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the ESI series. ESI was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the NRS and ODI. All patients reported average severity of their symptoms over the previous 1 week. A score of 0 on the NRS represents no pain, and a score of 10 represents the worst pain imaginable. The Korean version of the ODI (0-50) was used to assess functional improvement.

Official Title
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Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: epidural steroid (dexamethasone) injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: central spinal stenosis herniated nucleus pulposus. Exclusion Criteria: Lateral spinal stenosis Internal disc disruption
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural steroid injection<br>TF epidural steroid (dexamethasone) injection | Procedure: epidural steroid (dexamethasone) injection<br>* spinal injections performed in epidural space to relieve chronic low back pain or leg pain<br>|
| Active Comparator: IL epidural steroid injection<br>PS interlaminar epidural steroid(dexamethasone) injection | Procedure: epidural steroid (dexamethasone) injection<br>* spinal injections performed in epidural space to relieve chronic low back pain or leg pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | Numerical rating scale | 2 weeks after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention related time | time required to complete the intervention | 1 minutes after the completion of the intervention | 
| Exposed radiation amount during intervention | Exposed radiation amount during intervention | 1 minutes after the completion of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal stenosis, epidural steroid injection