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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
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring spinal stenosis, epidural steroid injection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 25, 2016
    Last Updated
    November 28, 2017
    Sponsor
    Keimyung University Dongsan Medical Center
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    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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