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NCT Number: NCT04832100

Bio-significance of LPC16:0 in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia, Primary Fibromyalgia Lipidomics Metabolomics Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Oxidative Stress Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Soreness, Muscle

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location status: Recruiting

Location contact

Chih-Hsien Hung

CONTACT

[email protected]

073121101 ext. 5851

Chih-Hsien Hung, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of fibromyalgia

Exclusion criteria

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

Treatment and study plan

Pregabalin 150mg, imipramine 25mg

Drug

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

Primary outcomes

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

    Time frame: Changes from baseline NRS at 2 weeks are assessed

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

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

    Time frame: Changes from baseline NRS at 4 weeks are assessed

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

  3. Questionnaire: widespread pain index and widespread soreness index

    Time frame: Change from baseline widespread index at 2 weeks are assessed

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

  4. Questionnaire: widespread pain index and widespread soreness index

    Time frame: Change from baseline widespread index at 4 weeks are assessed

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

  5. Questionnaire: Fibromyalgia impact questionnaire (FIQR)

    Time frame: Change from baseline FIQR at 2 weeks are assessed

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

  6. Questionnaire: Fibromyalgia impact questionnaire (FIQR)

    Time frame: Change from baseline FIQR at 4 weeks are assessed

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

  7. Questionnaire: Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline HADS at 2 weeks are assessed

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

  8. Questionnaire: Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline HADS at 4 weeks are assessed

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

  9. Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline PSQI at 2 weeks are assessed

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

  10. Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline PSQI at 4 weeks are assessed

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

  11. Questionnaire: Perceived stress scale (PSS)

    Time frame: Change from baseline PSS at 2 weeks are assessed

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

  12. Questionnaire: Perceived stress scale (PSS)

    Time frame: Change from baseline PSS at 4 weeks are assessed

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

  13. Metabolomics investigation

    Time frame: Change from baseline metabolomics at 3 months are assessed

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

  14. Lipidomics investigation

    Time frame: Change from baseline metabolomics at 3 months are assessed

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

  15. Metabolomics investigation

    Time frame: Change from baseline metabolomics at 6 months are assessed

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

  16. Lipidomics investigation

    Time frame: Change from baseline metabolomics at 6 months are assessed

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

  17. Metabolomics investigation

    Time frame: Change from baseline metabolomics at 9 months are assessed

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

  18. Lipidomics investigation

    Time frame: Change from baseline metabolomics at 9 months are assessed

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

  19. Metabolomics investigation

    Time frame: Change from baseline metabolomics at 12 months are assessed

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

  20. Lipidomics investigation

    Time frame: Change from baseline metabolomics at 12 months are assessed

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Apr 5, 2021
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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