Clinical trial NCT04930211: Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
Official title: The Effectiveness of Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain Associated With Modic Type-1 Change
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disc Disease
Low Back Pain
Keywords: transforaminal epidural injection
degenerative disc disease
modic changes
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: numeric rating scale
timeFrame: Baseline
measure: numeric rating scale
timeFrame: first month
measure: numeric rating scale
timeFrame: third month
measure: numeric rating scale
timeFrame: sixth month
Secondary outcomes:
measure: Oswestry disability index
timeFrame: Baseline
measure: Oswestry disability index
timeFrame: first month
measure: Oswestry disability index
timeFrame: third month
measure: Oswestry disability index
timeFrame: sixth month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Medicine
Study officials:
affiliation: Saniurfa Education and Research Hospital
name: Serdar Kokar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjaer P, Korsholm L, Bendix T, Sorensen JS, Leboeuf-Yde C. Modic changes and their associations with clinical findings. Eur Spine J. 2006 Sep;15(9):1312-9. doi: 10.1007/s00586-006-0185-x. Epub 2006 Aug 9.
citation: Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Jensen TS, Manniche C. Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI. Eur Spine J. 2012 Nov;21(11):2271-9. doi: 10.1007/s00586-012-2309-9. Epub 2012 Apr 24.
citation: Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M. 15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6.
citation: Buttermann GR. The effect of spinal steroid injections for degenerative disc disease. Spine J. 2004 Sep-Oct;4(5):495-505. doi: 10.1016/j.spinee.2004.03.024.