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Набор скоро начнётся NCT07641920

Assessment of Peripheral Neuropathy in Ankylosing Spondylitis

Наблюдательное Ankylosing Spondylitis Peripheral Neuropathies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nerve conduction study.
Кому может быть актуально
Состояния в реестре: Ankylosing Spondylitis, Peripheral Neuropathies. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessment of Peripheral Neuropathy in Ankylosing Spondylitis and Its Correlation With, Central Sensitization, Disease Activity and Quality of Life

Обзор

investigators hypothesized that peripheral neuropathy in ankylosing spondylitis is associated with higher disease activity, greater central sensitization, worse functional impairment, and poorer quality of life.

Подробное описание

Ankylosing spondylitis (AS) is a chronic inflammatory disease primarily affecting the axial skeleton, leading to persistent back pain, stiffness, and progressive functional impairment.

Pain in AS has been attributed to inflammation; however, accumulating evidence suggests that non-inflammatory mechanisms, including neuropathic pain and central sensitization, play a significant role in the overall pain experience.

Previous studies using screening tools such as Pain DETECT and S LANSS(Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs) questionnaires have reported that a considerable proportion of patients exhibit neuropathic pain features, with prevalence ranging from approximately 28% to over 50%. Moreover, neuropathic pain has been associated with higher disease activity scores, worse functional status, and impaired quality of life.

In addition, central sensitization defined as an amplification of neural signaling within the central nervous system has been proposed as a key contributor to chronic pain in AS. Neuroimaging and psychophysical studies have demonstrated alterations in brain structure and pain processing in AS patients, supporting the presence of central pain mechanisms.

Peripheral neuropathy may also occur in AS, potentially due to chronic inflammation, immune-mediated pathways, or mechanical and treatment-related factors. Electrophysiological evaluation using nerve conduction studies (NCS) provides an objective method for detecting large-fiber neuropathy and has revealed peripheral nervous system involvement in a subset of AS patients.

Disease activity in AS is commonly assessed using the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), while disease-specific quality of life can be evaluated using the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Understanding the interaction between inflammatory activity, neuropathic pain, and central sensitization is essential for optimizing patient management.

Вмешательства

  • Диагностический тест Nerve conduction study
    Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.

Первичные конечные точки

  • presence of peripheral neuropathy [Срок оценки: 1 month]

Критерии участия

Критерии включения

  • Patients aged ≥18 years
  • Diagnosis of ankylosing spondylitis according to the modified New York criteria (6).
  • Ability to provide informed consent

Критерии исключения

  • Patients under the age of 18 years.
  • Patients with definite diagnosis for any other systemic autoimmune disorders.
  • Diabetes mellitus
  • Chronic renal or hepatic disease
  • Alcohol abuse or drug-induced neuropathy
  • Known neurological disorders affecting peripheral nerves

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Египет · 1 центр
  • Assiut university — Asyut

Публикации

  • Atik S, Sahin O, Atik I, Polat M. Neuropathic Pain Component in Patients with Ankylosing Spondylitis and the Relationship of Neuropathic Pain and Disease Activity Parameters: A Cross-Sectional Study. J Musculoskelet Neuronal Interact. 2024 Sep 1;24(3):284-290. PMID 39219326
  • Wu Q, Inman RD, Davis KD. Neuropathic pain in ankylosing spondylitis: a psychophysics and brain imaging study. Arthritis Rheum. 2013 Jun;65(6):1494-503. doi: 10.1002/art.37920. PMID 23460087

Идентификаторы

NCT: NCT07641920 · Ankylosing.6.2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗