Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain

August 28, 2021 updated by: Marmara University

The Effectiveness of Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain Associated With Modic Type-1 Change

Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. Modic type 1 change is considered an inflammatory process. The aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. However, in degenerative disc disease, whether the pain could be attributed to Modic changes or not is still a matter of debate.

There are different options in the treatment of low back pain due to degenerative disc disease (DDD) and Modic changes. Conservative treatments and surgical approaches are some of them. Other interventional procedures include intradiscal and epidural steroid injections which have relatively less risk of complications than surgery.

The only study in the literature investigating the effectiveness of epidural steroid injections in patients with low back pain associated with modic changes belongs to Butterman et al. They reported that patients with Modic changes (type 1) responded better to epidural steroid injections than those without endplate irregularities. However, they did not report the details of the procedure, such as the steroid and local anesthetic they used, the amount of them and the level of the procedure. Moreover, they used different approaches including interlaminar and transforaminal, which may be misleading while interpreting the results.

Based on these results, the aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rakib Sacaklidir
  • Phone Number: +905538044082

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Marmara University, Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Non-radicular, axial back pain
  • Lack of response to conservative treatments
  • Detection of Modic type 1 changes in contrast-enhanced Lumbar MRI or intervertebral disc findings that may be associated with discogenic pain (nuclear signal intensity change in the disc [black disc], height loss, or high-intensity zone)

Exclusion Criteria:

  • Patients younger than 18 and older than 65
  • Describing pain radiating to the lower extremity (those with radicular pain)
  • Nerve root compression due to disc herniation or other reasons
  • Modic changes in more than one level
  • Positive facet loading test
  • Spinal stenosis or spondylolisthesis
  • Diagnosed with spondylodiscitis
  • Pregnancy
  • Patients with inflammatory rheumatic diseases
  • Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)
  • Patients with exercise intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modic Type-1 changes
Transforaminal Epidural Steroid Injection will be performed on patients at the pathology detected level bilaterally. The Kambin approach will be preferred in order to reach the intervertebral disc.
Drug: Dexamethasone-Lidocaine
Kambin's triangle approach in transforaminal epidural injection: Kambin's triangle is defined as a right triangle over the dorsolateral disc. The hypotenuse is the exiting nerve root, the base is the superior border of the caudal vertebra, and the height is the dura/traversing nerve root. it is possible to inject agents at the entrance and middle zone as the main areas of nerve entrapment by injecting at the retrodiscal area of the entrance zone, as proximal area of the targeted nerve root.
Other Names:
  • Transforaminal epidural steroid injection
Active Comparator: Degenerative disc disease without Modic Type-1 changes
Transforaminal Epidural Steroid Injection will be performed on patients at the pathology detected level bilaterally. The Kambin approach will be preferred in order to reach the intervertebral disc.
Drug: Dexamethasone-Lidocaine
Kambin's triangle approach in transforaminal epidural injection: Kambin's triangle is defined as a right triangle over the dorsolateral disc. The hypotenuse is the exiting nerve root, the base is the superior border of the caudal vertebra, and the height is the dura/traversing nerve root. it is possible to inject agents at the entrance and middle zone as the main areas of nerve entrapment by injecting at the retrodiscal area of the entrance zone, as proximal area of the targeted nerve root.
Other Names:
  • Transforaminal epidural steroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numeric rating scale
Time Frame: Baseline
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most severe pain that could be. The patient scores between 0 and 10 for pain.
Baseline
numeric rating scale
Time Frame: first month
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
first month
numeric rating scale
Time Frame: third month
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
third month
numeric rating scale
Time Frame: sixth month
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
sixth month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index
Time Frame: Baseline
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Baseline
Oswestry disability index
Time Frame: first month
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
first month
Oswestry disability index
Time Frame: third month
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
third month
Oswestry disability index
Time Frame: sixth month
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
sixth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Serdar Kokar, M.D., Saniurfa Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

October 5, 2022

Study Registration Dates

First Submitted

May 1, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2020.961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Dexamethasone-Lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe