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Bio-significance of LPC16:0 in Fibromyalgia

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04832100
Enrollment
245
Registered
2021-04-05
Start date
2021-06-01
Completion date
2027-06-30
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Primary, Lipidomics, Metabolomics, Oxidative Stress, Pain, Soreness, Muscle

Keywords

lysophosphotidylcholine, fibromyalgia, pain, soreness, metabolomics

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.

Interventions

DRUGPregabalin 150mg, imipramine 25mg

Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
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.

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire: Numeric rating scale (NRS) for pain and sorenessChanges from baseline NRS at 2 weeks are assessedassessment of pain and soreness severity. Score: 0(no symptom) \ 10 (worst symptom)
Questionnaire: widespread pain index and widespread soreness indexChange from baseline widespread index at 2 weeks are assessedassessment of pain and soreness diffuseness. Score: 0(no symptom) \ 19 (mostly diffused symptom)
Questionnaire: Fibromyalgia impact questionnaire (FIQR)Change from baseline FIQR at 2 weeks are assessedassessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) \ 100 (worst symptom)
Questionnaire: Hospital Anxiety and Depression Scale (HADS)Change from baseline HADS at 2 weeks are assessedassessment of psychological distress. Score: 0 (no symptom) \ 42 (worst symptom)
Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)Change from baseline PSQI at 2 weeks are assessedassessment of sleep quality. Score: 0 (no symptom) \ 21 (worst sleep quality)
Questionnaire: Perceived stress scale (PSS)Change from baseline PSS at 2 weeks are assessedassessment of perceived stress loading. Score: 0 (no stress) \ 40 (highest stressed level)
Metabolomics investigationChange from baseline metabolomics at 3 months are assessedLaboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.
Lipidomics investigationChange from baseline metabolomics at 3 months are assessedLaboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026