Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block

NCT ID: NCT06208865

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-07-02

Brief Summary

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.

Detailed Description

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.

Conditions

Low Back Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

lumbar erector spinae plane block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Damla Yürük

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ömer Taylan Akkaya, MD

Role: PRINCIPAL_INVESTIGATOR

Diskapi Teaching and Research Hospital

Ezgi Can, MD

Role: STUDY_DIRECTOR

Diskapi Teaching and Research Hospital

Locations

Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Lumbar ESPB

Identifier Type: -

Identifier Source: org_study_id