NCT05711121

Brief Summary

To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

January 9, 2023

Last Update Submit

February 13, 2023

Conditions

Lumbosacral Radiculopathy

Keywords

epidural injectionradicular paindisc herniationlumbosacral radiculopathytransforaminal injectioncaudal injection

Outcome Measures

Primary Outcomes (1)

  • 50 percent pain relief

    Number of patients having at least 50 percent pain relief

    3 months

Secondary Outcomes (3)

  • Oswestry Disability Index

    3 months

  • Procedure time

    during procedure

  • Radiation exposure

    during procedure

Study Arms (2)

S1 transforaminal

ACTIVE COMPARATOR

The group receiving S1 transforaminal epidural steroid injection

Procedure: Transforaminal epidural steroid injection

Caudal

ACTIVE COMPARATOR

The group receiving caudal epidural steroid injection

Procedure: Caudal epidural steroid injection

Interventions

Transforaminal epidural steroid injectionPROCEDURE

Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.

S1 transforaminal
Caudal epidural steroid injectionPROCEDURE

Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.

Caudal

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression.

You may not qualify if:

  • History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Osman Hakan Gunduz, Prof.

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

Ekim Can Ozturk, M.D.

CONTACT

+905448294239ekimtrilogy@gmail.com

Savas Sencan, Assoc. Prof.

CONTACT

+905370665713savas-44@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Patients and the investigator assessing the treatment results were blinded to the injection technique.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients having radicular pain were randomized to either caudal or transforaminal epidural injection group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 2, 2023

Study Start

January 1, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Patient data, statistics and study protocol can be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1 week

Locations

TU(1)