A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia
| Registry | NCT04832100 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 245 (Estimated) |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital (Other) |
| Conditions | Fibromyalgia, Primary, Pain, Soreness, Muscle, Oxidative Stress, Metabolomics, Lipidomics |
| Interventions | Pregabalin 150mg, imipramine 25mg (Drug) |
| Dates | start 2021-06-01, primary completion 2026-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2021-04-05, last updated 2025-06-26 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Fibromyalgia, Primary All trials for Pain All trials of Pregabalin 150mg, imipramine 25mg
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients with primary fibromyalgia | Drug: Pregabalin 150mg, imipramine 25mg | 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 . | |
| Healthy controls | Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls. |
Sex: All, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | Taiwan | Recruiting |