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Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838615
Enrollment
56
Registered
2016-07-20
Start date
2016-07-31
Completion date
2017-06-30
Last updated
2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

Keywords

spinal stenosis, epidural steroid injection

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.

Interventions

PROCEDUREepidural steroid (dexamethasone) injection

spinal injections performed in epidural space to relieve chronic low back pain or leg pain

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* central spinal stenosis * herniated nucleus pulposus.

Exclusion criteria

* Lateral spinal stenosis * Internal disc disruption

Design outcomes

Primary

MeasureTime frameDescription
Clinical efficacy2 weeks after study completionNumerical rating scale

Secondary

MeasureTime frameDescription
Intervention related time1 minutes after the completion of the interventiontime required to complete the intervention
Exposed radiation amount during intervention1 minutes after the completion of the interventionExposed radiation amount during intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026