Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain

Not Applicable

• Conditions: Low Back Pain; Degenerative Disc Disease
• Interventions: Drug: Dexamethasone-Lidocaine

• Registration Number: NCT04930211
• Lead Sponsor: Marmara University

Brief Summary

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.

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 Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-28
• Last Update Posted: 2021-08-31
• Primary Completion: 2022-08-01
• Study Completion: 2022-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modic Type-1 changes	Dexamethasone-Lidocaine	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.
Degenerative disc disease without Modic Type-1 changes	Dexamethasone-Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
numeric rating scale	sixth month	a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most

Secondary Outcome Measures

Name	Time	Method
Oswestry disability index	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.

Trial Locations

Locations (1)

Marmara University, Faculty of Medicine; 🇹🇷 Istanbul, Turkey