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Effect of Lumbar Interlaminar Epidural Injection on Restless Legs Syndrome in Patients With Lumbar Central Spinal Stenosis
Sponsor study identifier
observational
45
1 country
2
Study Start
June 1, 2025
Actual (reported)Primary Completion
December 1, 2025
Actual (reported)Study Completion
December 25, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 25, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2025
Actual (reported)December 1, 2025
Actual (reported)December 25, 2025
Actual (reported)June 4, 2026
Actual (reported)June 10, 2026
Actual (reported)Change in International Restless Legs Syndrome Rating Scale (IRLS) Score
The International Restless Legs Syndrome Rating Scale (IRLS) is a 10-item patient-reported questionnaire used to assess the severity of restless legs syndrome symptoms. Total scores range from 0 to 40, with higher scores indicating greater symptom severity. A decrease in score reflects clinical improvement.
Baseline and 3 Months
Change in Numeric Rating Scale (NRS) Pain Score
Baseline, 3 Weeks, and 3 Months
Change in Modified Oswestry Disability Index (MODI) Score
Baseline, 3 Weeks, and 3 Months
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Baseline, 3 Weeks, and 3 Months
Participants with lumbar central spinal stenosis and restless legs syndrome symptoms will receive a fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care. The injectate consists of dexamethasone, lidocaine, and normal saline. Participants will be evaluated at baseline, 3 weeks, and 3 months after the procedure for changes in restless legs syndrome severity, pain intensity, disability, and sleep quality.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult patients aged 18 to 75 years with moderate-to-severe lumbar central spinal stenosis confirmed by magnetic resonance imaging (MRI), chronic low back and leg pain refractory to conservative treatment, and symptoms consistent with restless legs syndrome who are scheduled to undergo fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care.
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)
Alp Eren Celenlioglu, MD./Assoc. Prof
University of Health Sciences Gulhane Training and Research Hospital, Department of Algology
45 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2026
First Posted
June 10, 2026
Study Start
June 1, 2025
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 1, 2025
Actual (reported)Study Completion
December 25, 2025
Actual (reported)Last Updated
June 10, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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