- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07637643
Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Ankara, Турция (Туркие)
- University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010
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Ankara, Турция (Туркие)
- University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010, Ankara,
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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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Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in International Restless Legs Syndrome Rating Scale (IRLS) Score
Временное ограничение: Baseline and 3 Months
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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.
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Baseline and 3 Months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Numeric Rating Scale (NRS) Pain Score
Временное ограничение: Baseline, 3 Weeks, and 3 Months
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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
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Baseline, 3 Weeks, and 3 Months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Modified Oswestry Disability Index (MODI) Score
Временное ограничение: Baseline, 3 Weeks, and 3 Months
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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.
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Baseline, 3 Weeks, and 3 Months
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
Временное ограничение: Baseline, 3 Weeks, and 3 Months
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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
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Baseline, 3 Weeks, and 3 Months
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Alp Eren Celenlioglu, MD./Assoc. Prof, University of Health Sciences Gulhane Training and Research Hospital, Department of Algology
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GEAH-ALGO- LSS HBS
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Синдром беспокойных ног
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Cognitive FXЗавершенныйПостконтузивный синдром | Неуточненное тревожное расстройство | Симптомы после сотрясения мозга | Постконтузионный синдром | Post Coversive Syndrome, хроническийСоединенные Штаты
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Reuth Rehabilitation HospitalРекрутингЛегкая черепно-мозговая травма, сотрясение мозга | Посттравматическая головная боль | Post Coversive Syndrome, хроническийИзраиль