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Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis

4 czerwca 2026 zaktualizowane przez: Saglik Bilimleri Universitesi

Effect of Lumbar Interlaminar Epidural Injection on Restless Legs Syndrome in Patients With Lumbar Central Spinal Stenosis

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

45

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Ankara, Turcja (Türkiye)
        • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010
      • Ankara, Turcja (Türkiye)
        • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010, Ankara,

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in International Restless Legs Syndrome Rating Scale (IRLS) Score
Ramy czasowe: Baseline and 3 Months
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Numeric Rating Scale (NRS) Pain Score
Ramy czasowe: Baseline, 3 Weeks, and 3 Months
Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. A reduction in NRS score reflects improvement in pain
Baseline, 3 Weeks, and 3 Months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in Modified Oswestry Disability Index (MODI) Score
Ramy czasowe: Baseline, 3 Weeks, and 3 Months
Disability related to low back pain will be assessed using the Modified Oswestry Disability Index (MODI). Total scores range from 0 to 100, with higher scores indicating greater disability and functional impairment. A reduction in MODI score reflects improvement in functional status.
Baseline, 3 Weeks, and 3 Months
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Ramy czasowe: Baseline, 3 Weeks, and 3 Months
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A reduction in PSQI score reflects improvement in sleep quality
Baseline, 3 Weeks, and 3 Months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Alp Eren Celenlioglu, MD./Assoc. Prof, University of Health Sciences Gulhane Training and Research Hospital, Department of Algology

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2025

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2025

Ukończenie studiów (Rzeczywisty)

25 grudnia 2025

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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