Spinal Stenosis Clinical Trial
Official title:
Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach
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.
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.
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