An interventional study of epidural steroid (dexamethasone) injection in Spinal Stenosis, sponsored by Keimyung University Dongsan Medical Center. Completed. Per ClinicalTrials.gov, last updated 2017-11-29.
Sponsored by Keimyung University Dongsan Medical Center · Not applicable, Interventional, and Treatment
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.
469 studies on the registry are indexed under Spinal Stenosis; 106 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 289 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
TF epidural steroid (dexamethasone) injection
Procedure: epidural steroid (dexamethasone) injection
PS interlaminar epidural steroid(dexamethasone) injection
Procedure: epidural steroid (dexamethasone) injection
spinal injections performed in epidural space to relieve chronic low back pain or leg pain
Clinical efficacy
Numerical rating scale
Time frame: 2 weeks after study completion
Intervention related time
time required to complete the intervention
Time frame: 1 minutes after the completion of the intervention
Exposed radiation amount during intervention
Exposed radiation amount during intervention
Time frame: 1 minutes after the completion of the intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Keimyung University Dongsan Medical Center