Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection
Primary Purpose
Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
epidural steroid (dexamethasone) injection
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis focused on measuring spinal stenosis, epidural steroid injection
Eligibility Criteria
Inclusion Criteria:
- central spinal stenosis
- herniated nucleus pulposus.
Exclusion Criteria:
- Lateral spinal stenosis
- Internal disc disruption
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
epidural steroid injection
IL epidural steroid injection
Arm Description
TF epidural steroid (dexamethasone) injection
PS interlaminar epidural steroid(dexamethasone) injection
Outcomes
Primary Outcome Measures
Clinical efficacy
Numerical rating scale
Secondary Outcome Measures
Intervention related time
time required to complete the intervention
Exposed radiation amount during intervention
Exposed radiation amount during intervention
Full Information
NCT ID
NCT02838615
First Posted
May 25, 2016
Last Updated
November 28, 2017
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02838615
Brief Title
Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection
Official Title
Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
spinal stenosis, epidural steroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
epidural steroid injection
Arm Type
Active Comparator
Arm Description
TF epidural steroid (dexamethasone) injection
Arm Title
IL epidural steroid injection
Arm Type
Active Comparator
Arm Description
PS interlaminar epidural steroid(dexamethasone) injection
Intervention Type
Procedure
Intervention Name(s)
epidural steroid (dexamethasone) injection
Intervention Description
spinal injections performed in epidural space to relieve chronic low back pain or leg pain
Primary Outcome Measure Information:
Title
Clinical efficacy
Description
Numerical rating scale
Time Frame
2 weeks after study completion
Secondary Outcome Measure Information:
Title
Intervention related time
Description
time required to complete the intervention
Time Frame
1 minutes after the completion of the intervention
Title
Exposed radiation amount during intervention
Description
Exposed radiation amount during intervention
Time Frame
1 minutes after the completion of the intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
central spinal stenosis
herniated nucleus pulposus.
Exclusion Criteria:
Lateral spinal stenosis
Internal disc disruption
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection
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