Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block

NCT06208865 | Completed

• 1 other identifier: Lumbar ESPB
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

plane block; low back pain; lumbar radiculopathy; fatty infiltration; erector spinae muscles

Outcome Measures

Primary Outcomes (1)

• VAS

  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

Interventions

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.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Ömer Taylan Akkaya, MD

  Diskapi Teaching and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ezgi Can, MD

  Diskapi Teaching and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 17, 2024
• Study Start: November 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 2, 2023
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

TU (1)