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CompletedNCT02838615Updated Nov 29, 2017

Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

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

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spinal Stenosis

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Keywords

  • spinal stenosis
  • epidural steroid injection
03

In context

Spinal Stenosis

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 →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • central spinal stenosis
  • herniated nucleus pulposus.

Exclusion criteria

Exclusion Criteria:

  • Lateral spinal stenosis
  • Internal disc disruption
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    epidural steroid injection

    TF epidural steroid (dexamethasone) injection

    Procedure: epidural steroid (dexamethasone) injection

  • Active comparator
    IL epidural steroid injection

    PS interlaminar epidural steroid(dexamethasone) injection

    Procedure: epidural steroid (dexamethasone) injection

Interventions

  • Procedureepidural steroid (dexamethasone) injection

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

06

What researchers measure

Primary outcomes

  1. Clinical efficacy

    Numerical rating scale

    Time frame: 2 weeks after study completion

Secondary outcomes

  1. Intervention related time

    time required to complete the intervention

    Time frame: 1 minutes after the completion of the intervention

  2. Exposed radiation amount during intervention

    Exposed radiation amount during intervention

    Time frame: 1 minutes after the completion of the intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02838615
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Ji Hee Hong (Associate professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Jul 20, 2016
Start date
Jul 2016
Primary completion
May 2017
Completion
Jun 2017
Last update
Nov 29, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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