Clinical trial NCT04832100: Bio-significance of LPC16:0 in Fibromyalgia
Official title: A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia, Primary
Pain
Soreness, Muscle
Oxidative Stress
Metabolomics
Lipidomics
Keywords: lysophosphotidylcholine
fibromyalgia
pain
soreness
metabolomics
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient group: participants with primary fibromyalgia Control group: healthy controls

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.

Primary outcomes:
measure: Questionnaire: Numeric rating scale (NRS) for pain and soreness
timeFrame: Changes from baseline NRS at 2 weeks are assessed
measure: Questionnaire: Numeric rating scale (NRS) for pain and soreness
timeFrame: Changes from baseline NRS at 4 weeks are assessed
measure: Questionnaire: widespread pain index and widespread soreness index
timeFrame: Change from baseline widespread index at 2 weeks are assessed
measure: Questionnaire: widespread pain index and widespread soreness index
timeFrame: Change from baseline widespread index at 4 weeks are assessed
measure: Questionnaire: Fibromyalgia impact questionnaire (FIQR)
timeFrame: Change from baseline FIQR at 2 weeks are assessed
measure: Questionnaire: Fibromyalgia impact questionnaire (FIQR)
timeFrame: Change from baseline FIQR at 4 weeks are assessed
measure: Questionnaire: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS at 2 weeks are assessed
measure: Questionnaire: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS at 4 weeks are assessed
measure: Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline PSQI at 2 weeks are assessed
measure: Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline PSQI at 4 weeks are assessed
measure: Questionnaire: Perceived stress scale (PSS)
timeFrame: Change from baseline PSS at 2 weeks are assessed
measure: Questionnaire: Perceived stress scale (PSS)
timeFrame: Change from baseline PSS at 4 weeks are assessed
measure: Metabolomics investigation
timeFrame: Change from baseline metabolomics at 3 months are assessed
measure: Lipidomics investigation
timeFrame: Change from baseline metabolomics at 3 months are assessed
measure: Metabolomics investigation
timeFrame: Change from baseline metabolomics at 6 months are assessed
measure: Lipidomics investigation
timeFrame: Change from baseline metabolomics at 6 months are assessed
measure: Metabolomics investigation
timeFrame: Change from baseline metabolomics at 9 months are assessed
measure: Lipidomics investigation
timeFrame: Change from baseline metabolomics at 9 months are assessed
measure: Metabolomics investigation
timeFrame: Change from baseline metabolomics at 12 months are assessed
measure: Lipidomics investigation
timeFrame: Change from baseline metabolomics at 12 months are assessed
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References: