跳至主要内容
临床试验/NCT04832100
NCT04832100招募中不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
245
试验地点
1
主要终点
Questionnaire: widespread pain index and widespread soreness index

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of fibromyalgia

排除标准

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

研究组 & 干预措施

Patients with primary fibromyalgia

Adults with complaints of chronic widespread pain at the outpatient department of KMUH were consecutively enrolled over a 5-year period from June 2021 to June 2026. Participants were interviewed by experienced neurologists , and those who fulfilled the 2011 American College of Rheumatology (ACR) criteria for FM were recruited .

干预措施: Pregabalin 150mg, imipramine 25mg (Drug)

结局指标

主要结局

Questionnaire: widespread pain index and widespread soreness index

时间窗: Change from baseline widespread index at 4 weeks are assessed

assessment of pain and soreness diffuseness. Score: 0(no symptom) \~19 (mostly diffused symptom)

Questionnaire: Fibromyalgia impact questionnaire (FIQR)

时间窗: Change from baseline FIQR at 4 weeks are assessed

assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) \~100 (worst symptom)

Questionnaire: Perceived stress scale (PSS)

时间窗: Change from baseline PSS at 4 weeks are assessed

assessment of perceived stress loading. Score: 0 (no stress) \~40 (highest stressed level)

Metabolomics investigation

时间窗: Change from baseline metabolomics at 12 months are assessed

Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.

Questionnaire: Hospital Anxiety and Depression Scale (HADS)

时间窗: Change from baseline HADS at 4 weeks are assessed

assessment of psychological distress. Score: 0 (no symptom) \~42 (worst symptom)

Questionnaire: Numeric rating scale (NRS) for pain and soreness

时间窗: Changes from baseline NRS at 4 weeks are assessed

assessment of pain and soreness severity. Score: 0(no symptom) \~10 (worst symptom)

Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)

时间窗: Change from baseline PSQI at 4 weeks are assessed

assessment of sleep quality. Score: 0 (no symptom) \~21 (worst sleep quality)

Lipidomics investigation

时间窗: Change from baseline metabolomics at 12 months are assessed

Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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