Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930211
• Other study ID #: 09.2020.961
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: October 5, 2022

Study information

• Verified date: August 2021
• Source: Marmara University
• Contact: Serdar Kokar, M.D.
• Phone: +905416415143
• Email: srdrkkr[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 5, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University, Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Buttermann GR. The effect of spinal steroid injections for degenerative disc disease. Spine J. 2004 Sep-Oct;4(5):495-505. — View 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. — View 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. Review. — View 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. Epub 2006 Aug 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numeric rating scale	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
Primary	numeric rating scale	a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most	first month
Primary	numeric rating scale	a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most	third month
Primary	numeric rating scale	a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most	sixth month
Secondary	Oswestry disability index	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
Secondary	Oswestry disability index	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
Secondary	Oswestry disability index	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
Secondary	Oswestry disability index	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