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Bio-significance of LPC16:0 in Fibromyalgia

NCT04832100 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 245

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Pregabalin 150mg, imipramine 25mg

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

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04832100 on ClinicalTrials.gov