Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block

This study aimed to investigate the relationship between fatty infiltration in the lumbar paraspinal (multifidus and erector spinae) muscles, clinical characteristics, and treatment response after lumbar erector spinae plane block (ESPB) in patients with low back pain due to lumbar radiculopathy. A responder was defined as a patient with a numerical rating scale (NRS) decrease of ≥ 50% from baseline to one month after the procedure. The presence of fat infiltration in the lumbar paraspinal muscles was assessed, along with patient demographic and clinical characteristics.

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Key information

Conditions

Low Back Pain Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

Low back pain (LBP) is a common health problem that causes global disability. Lumbosacral radiculopathy (LR) is the most common cause of low back pain. Disc herniation is the most common cause of LR, in addition to spinal stenosis, foraminal stenosis, facet joint hypertrophy, and degenerative disease (1). Treatment options for lumbar disc herniation include conservative treatment, interventional pain management, and surgery. Lumbar erector spinae plane block (ESPB) is an interventional procedure for chronic axial and radicular low back pain which that is unresponsive to conservative treatment.

Lumbar paraspinal muscles play an important role in maintaining lumbar spine stability. Increased fat infiltration in the paraspinal muscles has been associated with high-intensity low back pain and poor functional status, and fat infiltration in the paraspinal muscles can be detected by lumbar magnetic resonance imaging. In this study, fatty infiltration in the bilateral lumbar multifidus muscles was evaluated at the L3 level using Goutallier classification.

The primary aim of this study was to investigate the potential relationship between the treatment outcome of lumbar ESPB and the degree of fatty infiltration in the paraspinal muscles in patients with chronic axial and/or radicular low back pain unresponsive to conservative treatments. The secondary aim was to identify other factors that may be associated with a successful response to lumbar ESPB and fatty infiltration of the paraspinal muscles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

lumbar radicular pain
no response to conservative treatment for > 3 months
MRI within 1 year prior to injection.

Exclusion criteria

inadequate medical records with missing numerical rating scale (NRS) scores and MRI images
patients lost to follow-up within one month after lumbar ESPB
patients with a history of surgery for lumbar disc herniation
patients with severe spinal and/or foraminal stenosis
patients with extruded, sequestrated, or migrating hernias.

Treatment and study plan

Lumbar Erector Spinae Plane Block

Procedure

All procedures were performed under ultrasound (US) guidance. The patient was monitored in the operating room and placed in the prone position under a sterile drape. A 2-6 MHz convex US probe was used during the procedure. The transverse processes of the lumbar vertebrae were visualized and then a 22 gauge spinal needle was advanced to the transverse process of the L3 vertebra. After contacting the transverse process, a total of 15 mL of drug consisting of 2 mL of methylprednisolone and 6 mL of 0.025% bupivacaine was injected into this area, and the spread of the drug in the craniocaudal area was visualized. The patients were followed up for possible complications after the procedure.

Primary outcomes

VAS

Time frame: Change from Baseline NRS at 3 months

Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

Association of Fatty Infiltration in Paraspinal Muscles With the Analgesic Effect of Lumbar Erector Spina Plane Block

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 17, 2024
Registry last updated: Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed