NCT04832100 Bio-significance of LPC16:0 in Fibromyalgia
| NCT ID | NCT04832100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Condition | Fibromyalgia, Primary |
| Study Type | OBSERVATIONAL |
| Enrollment | 245 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 245 participants in total. It began in 2021-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1\. Clinical diagnosis of fibromyalgia Exclusion Criteria: 1. Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis), 2. Systemic use of corticosteroids, 3. Pregnancy, 4. Chronic diseases under poor control 5. Malignancies.
Frequently Asked Questions
Who can join the NCT04832100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Fibromyalgia, Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04832100 currently recruiting?
Yes, NCT04832100 is actively recruiting participants. Visit ClinicalTrials.gov or contact Kaohsiung Medical University Chung-Ho Memorial Hospital to inquire about joining.
Where is the NCT04832100 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT04832100 clinical trial?
NCT04832100 is sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. The trial plans to enroll 245 participants.
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