Clinical trial NCT02838615: Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection
Official title: Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Keywords: spinal stenosis
epidural steroid injection
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* central spinal stenosis
* herniated nucleus pulposus.

Exclusion Criteria:

* Lateral spinal stenosis
* Internal disc disruption

Primary outcomes:
measure: Clinical efficacy
timeFrame: 2 weeks after study completion
Secondary outcomes:
measure: Intervention related time
timeFrame: 1 minutes after the completion of the intervention
measure: Exposed radiation amount during intervention
timeFrame: 1 minutes after the completion of the intervention
Other outcomes:
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