Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis

NCT07637643 | Completed

• 1 other identifier: GEAH-ALGO- LSS HBS
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lumbar Central Spinal Stenosis; Restless Legs Syndrome

Keywords

Lumbar Central Spinal Stenosis; Restless Legs Syndrome; Secondary Restless Legs Syndrome; Epidural Steroid Injection; Lumbar Interlaminar Epidural Injection; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Numeric Rating Scale (NRS) Pain Score

  Baseline, 3 Weeks, and 3 Months

Other Outcomes (2)

• 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

Study Arms (1)

Lumbar Interlaminar Epidural Steroid Injection

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.

Procedure: Lumbar Interlaminar Epidural Steroid Injection

Interventions

Lumbar Interlaminar Epidural Steroid Injection PROCEDURE

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.

Lumbar Interlaminar Epidural Steroid Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (2)

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

Ankara, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Alp Eren Celenlioglu, MD./Assoc. Prof

  University of Health Sciences Gulhane Training and Research Hospital, Department of Algology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 25, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)