Lumbar central spinal stenosis (LCSS) is one of the most common causes of chronic low back and leg pain in older adults. Degenerative narrowing of the spinal canal may lead to compression of neural structures, resulting in pain, neurogenic claudication, sensory symptoms, functional impairment, and reduced quality of life. Lumbar interlaminar epidural steroid injection (LIESI) is a frequently performed minimally invasive treatment option for patients with symptomatic LCSS who do not achieve adequate relief with conservative treatment modalities.
Restless legs syndrome (RLS) is a sensorimotor disorder characterized by an urge to move the legs, usually accompanied by unpleasant sensations that worsen during rest and improve with movement. Several studies have suggested an association between lumbar spinal disorders and secondary RLS symptoms. Chronic pain, neural irritation, inflammatory mediators, sleep disturbance, and impaired mobility may contribute to the development or worsening of RLS in patients with lumbar spinal stenosis. However, data regarding the effect of epidural steroid injections on RLS symptoms remain limited.
The purpose 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 moderate-to-severe lumbar central spinal stenosis confirmed by magnetic resonance imaging (MRI), persistent low back and leg pain despite conservative treatment, and symptoms consistent with restless legs syndrome will be enrolled. All participants will receive fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care. No additional intervention beyond standard treatment will be performed for research purposes.
Baseline demographic and clinical characteristics, including symptom duration, pain intensity, disability level, sleep quality, and radiological severity of spinal stenosis, will be recorded. Outcome assessments will be performed before the procedure and at 3 weeks and 3 months after treatment. Restless legs syndrome severity will be assessed using the International Restless Legs Syndrome Rating Scale (IRLS). Pain intensity will be measured using the Numeric Rating Scale (NRS), disability using the Modified Oswestry Disability Index (MODI), and sleep quality using the Pittsburgh Sleep Quality Index (PSQI).
The primary objective is to determine whether lumbar interlaminar epidural steroid injection is associated with improvement in RLS symptom severity at 3 months compared with baseline. Secondary objectives include evaluating changes in pain intensity, disability, and sleep quality following treatment. The findings of this study may improve understanding of the relationship between lumbar spinal stenosis, chronic pain, and restless legs syndrome, and may help identify additional clinical benefits of epidural steroid injection beyond pain relief alone.