NCT06275529

Brief Summary

Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes. The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

March 5, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

February 17, 2024

Last Update Submit

March 3, 2025

Conditions

Radiculopathy LumbarLow Back PainDisc HerniationInjections, Epidural

Outcome Measures

Primary Outcomes (2)

  • Change of the pain severity score

    Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the ten groups will be compared.

    Pre-intervention, post-intervention 1th month and post-intervention 3rd month

  • Change of the disability score

    Disability conditions of the patients are assessed by using "Oswestry Disability Index" (ODI). ODI is a patient completed questionnaire which gives a percentage score of disability. The ODI is comprised of 10 items and enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). The change in ODI scores between the ten groups will be compared.

    Pre-intervention, post-intervention 1th month and post-intervention 3rd month

Study Arms (10)

MSU Classification 1A

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 1B

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 1C

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2A

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2B

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2C

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 3A

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 3B

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2AB

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 3AB

EXPERIMENTAL

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB

Procedure: Transforaminal Epidural Steroid Injection

Interventions

Transforaminal Epidural Steroid InjectionPROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections: After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 1AMSU Classification 1BMSU Classification 1CMSU Classification 2AMSU Classification 2ABMSU Classification 2BMSU Classification 2CMSU Classification 3AMSU Classification 3ABMSU Classification 3B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 18-65
  • After outpatient evaluation, a decision was made to perform transforaminal steroid injection,
  • Low back pain of more than 6 on a numeric rating scale (NRS)
  • Radiculopathy for more than 4 weeks and less than one year and straight leg raising \<45
  • Disc herniation at the L4-L5 or L5-S1 level on MRI
  • Failure to respond to medical treatment for at least one month

You may not qualify if:

  • Neurological deficit,
  • Bleeding problems,
  • Localized infection,
  • Spinal pathologies (such as tumors),
  • Fractures,
  • Severe stenosis,
  • Uncontrolled diabetes,
  • Pregnancy,
  • Red flag symptoms (such as motor and/or sphincter dysfunction)
  • Patient reluctance,
  • Computed tomography (CT) and MRI findings in favor of sequestrated fragments from herniated disc,
  • Sphincteric disorders,
  • Previous spine surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Tuba Tanyel Saraçoğlu, MD

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 23, 2024

Study Start

March 15, 2024

Primary Completion

October 15, 2024

Study Completion

January 15, 2025

Last Updated

March 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)