Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain

NCT04930211 | Unknown

• 1 other identifier: 09.2020.961
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Low Back Pain

Keywords

transforaminal epidural injection; degenerative disc disease; modic changes

Outcome Measures

Primary Outcomes (4)

• 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

• numeric rating scale

  a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most

  first month

• numeric rating scale

  a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most

  third month

• 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 Outcomes (4)

• Oswestry disability index

  Baseline

• Oswestry disability index

  first month

• Oswestry disability index

  third month

• Oswestry disability index

  sixth month

Study Arms (2)

Modic Type-1 changes

ACTIVE COMPARATOR

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

Degenerative disc disease without Modic Type-1 changes

ACTIVE COMPARATOR

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

Interventions

Dexamethasone-Lidocaine DRUG

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.

Also known as: Transforaminal epidural steroid injection

Degenerative disc disease without Modic Type-1 changes; Modic Type-1 changes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 16896838 BACKGROUND

• 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.

  PMID: 22526703 BACKGROUND

• 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.

  PMID: 20825564 BACKGROUND

• 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.

  PMID: 15363419 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serdar Kokar, M.D.

  Saniurfa Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serdar Kokar, M.D.

CONTACT

+905416415143; srdrkkr@hotmail.com

Rakib Sacaklidir

CONTACT

+905538044082

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: June 18, 2021
• Study Start: October 5, 2020
• Primary Completion: August 1, 2022
• Study Completion: October 5, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)