Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis (NCT07637643) | Clinical Trial Compass
CompletedNot Applicable
Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis
Turkey (Türkiye)45 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether epidural steroid injections changed restless legs symptom scores in people with lumbar spinal stenosis — do you think my restless legs symptoms could actually be coming from my spine compression rather than being a separate condition, and does that change how you'd treat me?
2Since this trial has already completed and was measuring changes in a standard restless legs rating scale called the IRLS, can you tell me if the results have been published yet, and what they might mean for whether an epidural steroid injection is worth considering in my case?
3Before trying an epidural steroid injection for restless legs symptoms tied to spinal stenosis, should I first exhaust standard restless legs treatments like medications or iron therapy, or does my stenosis diagnosis make the injection a more logical first step?
4An epidural steroid injection is an interventional procedure — what are the realistic risks I should weigh, especially given that this trial was studying it for restless legs symptoms rather than the more traditional use for back or leg pain?
5If my restless legs symptoms turn out to be linked to my lumbar stenosis, are there other treatment options for that connection — like physical therapy or surgical decompression — that I should be comparing against an epidural steroid injection?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in International Restless Legs Syndrome Rating Scale (IRLS) Score