Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis
CompletedNCT07637643
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Lumbar Interlaminar Epidural Injection on Restless Legs Syndrome in Patients With Lumbar Central Spinal Stenosis
- Conditions
- Lumbar Central Spinal Stenosis
- Restless Legs Syndrome
- Interventions
- Procedure: Lumbar Interlaminar Epidural Steroid Injection
- Sponsor
- Saglik Bilimleri Universitesi
- Start date
- 2025-06-01
- Primary completion
- 2025-12-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Turkey (Türkiye)
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Age between 18 and 75 years Ability to understand the study procedures and provide written informed consent Moderate or severe lumbar central spinal stenosis confirmed by magnetic resonance imaging (MRI) Chronic low back and leg pain attributed to lumbar central spinal stenosis Symptoms of restless legs syndrome Pain intensity ≥4 on the Numeric Rating Scale (NRS) Symptom duration ≥3 months Persistent symptoms despite conservative treatment and maximum tolerated medical therapy Planned fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care - Exclusion Criteria: Radicular pain limited to a single nerve root distribution Vascular claudication History of peripheral vascular disease Previous lumbosacral spine surgery Polyneuropathy or lower extremity entrapment neuropathy Local or systemic infection Rheumatologic disease Neurodegenerative disease Diabetes mellitus Moderate to severe chronic kidney disease Ankylosing spondylitis or rheumatoid arthritis Epidural steroid injection within the previous 6 months Foraminal stenosis causing dynamic or postural radiculopathy Current use of antidepressant, sedative, or hypnotic medications Iron deficiency anemia Vitamin B12 deficiency Known history of restless legs syndrome or family history of restless legs syndrome Failure to receive maximum tolerated medical therapy \-
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07637643