NCT02838615

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

May 25, 2016

Last Update Submit

November 28, 2017

Conditions

Spinal Stenosis

Keywords

spinal stenosisepidural steroid injection

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy

    Numerical rating scale

    2 weeks after study completion

Secondary Outcomes (2)

  • Intervention related time

    1 minutes after the completion of the intervention

  • Exposed radiation amount during intervention

    1 minutes after the completion of the intervention

Study Arms (2)

epidural steroid injection

ACTIVE COMPARATOR

TF epidural steroid (dexamethasone) injection

Procedure: epidural steroid (dexamethasone) injection

IL epidural steroid injection

ACTIVE COMPARATOR

PS interlaminar epidural steroid(dexamethasone) injection

Procedure: epidural steroid (dexamethasone) injection

Interventions

epidural steroid (dexamethasone) injectionPROCEDURE

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

IL epidural steroid injectionepidural steroid injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • central spinal stenosis
  • herniated nucleus pulposus.

You may not qualify if:

  • Lateral spinal stenosis
  • Internal disc disruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Stenosis

Interventions

DexamethasoneInjections

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 25, 2016

First Posted

July 20, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share