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Идёт набор NCT04832100

Bio-significance of LPC16:0 in Fibromyalgia

— Наблюдательное Fibromyalgia, Primary Pain Soreness, Muscle Oxidative Stress

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: Pregabalin 150mg, imipramine 25mg.
Кому может быть актуально
Состояния в реестре: Fibromyalgia, Primary, Pain, Soreness, Muscle, Oxidative Stress. Базовые параметры: 18 лет — 70 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
Тайвань
Следующий шаг
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Официальное название

A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia

Обзор

Fibromyalgia (FM) is a very common but mysterious pain disorder characterized by chronic widespread muscular pain. Fatigue, anxiety and depression are common comorbidities. The syndrome is commonly associated with several symptoms, including fatigue, sleeping disturbance, cognitive impairment, and comorbid pain syndrome, especially irritable bowel symptoms and temporomandibular disease. Anxiety and depression are common psychiatric co-morbidies. Daily stress is believed to trigger or aggravate pain conditions. These symptoms can markedly affect patients' quality of life, and even lead to disability. So far, the etiology and pathogenesis are largely unknown, and diagnostic biomarkers and curative treatment remain to be developed. Recent technological advances enable scientists to explore mechanisms by genetic, transcriptomic, proteomic, and metabolomic researches. However, no definitive result has been concluded for clinical practice so far. In this study, the investigators use tailored questionnaires to evaluate fibromyalgia and associated symptoms, including numeric rating scale for soreness, widespread soreness index, Fibromyalgia impact questionnaire, Hospital Anxiety and Depression Scale, and perceived stress scale. The investigators also use metabolomics and lipidomic approach to probe the potential pathophysiology of fibromyalgia. In our prior translation research (PMID: 32907805), the investigators found that excessive LPC16:0 resulting from lipid oxidization inflicts psychological stress-induced chronic non-inflammatory pain via activating ASIC3. In this content, our prior translational research identified a potential nociceptive ligand that causes fibromyalgia symptoms, which is likely to function as biomarkers for diagnosis or disease monitor. In the current clinical investigation, the investigators aim to reversely translate the novel findings in animal studies and validate the bio-significance of LPC16:0 for fibromyalgia with clinical approaches.

Вмешательства

  • Препарат Pregabalin 150mg, imipramine 25mg
    Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.

Первичные конечные точки

  • Questionnaire: Numeric rating scale (NRS) for pain and soreness [Срок оценки: Changes from baseline NRS at 2 weeks are assessed]
  • Questionnaire: Numeric rating scale (NRS) for pain and soreness [Срок оценки: Changes from baseline NRS at 4 weeks are assessed]
  • Questionnaire: widespread pain index and widespread soreness index [Срок оценки: Change from baseline widespread index at 2 weeks are assessed]
  • Questionnaire: widespread pain index and widespread soreness index [Срок оценки: Change from baseline widespread index at 4 weeks are assessed]
  • Questionnaire: Fibromyalgia impact questionnaire (FIQR) [Срок оценки: Change from baseline FIQR at 2 weeks are assessed]
  • Questionnaire: Fibromyalgia impact questionnaire (FIQR) [Срок оценки: Change from baseline FIQR at 4 weeks are assessed]
  • Questionnaire: Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Change from baseline HADS at 2 weeks are assessed]
  • Questionnaire: Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Change from baseline HADS at 4 weeks are assessed]
  • Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Change from baseline PSQI at 2 weeks are assessed]
  • Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Change from baseline PSQI at 4 weeks are assessed]

Критерии участия

Критерии включения

1\. Clinical diagnosis of fibromyalgia

Критерии исключения

  • Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis),
  • Systemic use of corticosteroids,
  • Pregnancy,
  • Chronic diseases under poor control
  • Malignancies.

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

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Тайвань · 1 центр
  • Kaohsiung Medical University Hospital — Kaohsiung City

Публикации

  • Hung CH, Tsai MH, Wang PS, Liang FW, Hsu CY, Lee KW, Fong YO, Han DS, Lee CH, Lai CL, Chen CC. Oxidative stress involves phenotype modulation of morbid soreness symptoms in fibromyalgia. RMD Open. 2023 Mar;9(1):e002741. doi: 10.1136/rmdopen-2022-002741. PMID 36918228

Идентификаторы

NCT: NCT04832100 · KMUHIRB-G(I)-20170012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗