Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block

April 5, 2024 updated by: Damla Yürük, Diskapi Teaching and Research Hospital

Association of Fatty Infiltration in Paraspinal Muscles With the Analgesic Effect of 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female patients who underwent lumbar erector spinae plane block for low back pain due to lumbar radiculopathy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline NRS at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ömer Taylan Akkaya, MD, Diskapi Teaching and Research Hospital
  • Study Director: Ezgi Can, MD, Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 2, 2023

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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