- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06208865
Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block
Association of Fatty Infiltration in Paraspinal Muscles With the Analgesic Effect of Lumbar Erector Spina Plane Block
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Ankara Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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.
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Change from Baseline NRS at 3 months
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Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lumbar ESPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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