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COMPLETED
NCT07637643

Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis

Sponsor: Saglik Bilimleri Universitesi

View on ClinicalTrials.gov

Summary

Lumbar central spinal stenosis (LCSS) is a common degenerative spinal disorder characterized by narrowing of the spinal canal, resulting in chronic low back pain, leg pain, and neurogenic claudication. Restless legs syndrome (RLS) is frequently observed in patients with lumbar spinal disorders and may contribute substantially to sleep disturbance and reduced quality of life. Although lumbar interlaminar epidural steroid injection (LIESI) is widely used to alleviate pain and improve functional status in patients with LCSS, its effect on RLS symptoms has not been adequately investigated. The aim of this prospective observational study is to evaluate the effect of lumbar interlaminar epidural steroid injection on restless legs syndrome symptoms in patients with lumbar central spinal stenosis. Adult patients with symptomatic moderate-to-severe lumbar central spinal stenosis who have persistent pain despite conservative treatment and who also report symptoms consistent with restless legs syndrome will be enrolled. Participants will undergo standard fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care. Restless legs syndrome severity, pain intensity, disability, and sleep quality will be assessed before the procedure and at 3 weeks and 3 months after treatment using the International Restless Legs Syndrome Rating Scale (IRLS), Numeric Rating Scale (NRS), Modified Oswestry Disability Index (MODI), and Pittsburgh Sleep Quality Index (PSQI), respectively. The primary outcome is the change in IRLS score from baseline to 3 months. Secondary outcomes include changes in pain intensity, disability, and sleep quality following treatment. This study aims to provide evidence regarding the relationship between epidural pain treatment and restless legs syndrome symptoms in patients with lumbar central spinal stenosis.

Official title: Effect of Lumbar Interlaminar Epidural Injection on Restless Legs Syndrome in Patients With Lumbar Central Spinal Stenosis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

45

Start Date

2025-06-01

Completion Date

2025-12-25

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

PROCEDURE

Lumbar Interlaminar Epidural Steroid Injection

Fluoroscopy-guided lumbar interlaminar epidural steroid injection using dexamethasone, lidocaine, and normal saline in patients with lumbar central spinal stenosis and restless legs syndrome symptoms.

Locations (2)

University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010, Ankara,

Ankara, Turkey (Türkiye)

University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010

Ankara, Turkey (Türkiye)