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.
Study Type
OBSERVATIONAL
Enrollment
245
Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
RECRUITINGQuestionnaire: Numeric rating scale (NRS) for pain and soreness
assessment of pain and soreness severity. Score: 0(no symptom) \~10 (worst symptom)
Time frame: Changes from baseline NRS at 2 weeks are assessed
Questionnaire: Numeric rating scale (NRS) for pain and soreness
assessment of pain and soreness severity. Score: 0(no symptom) \~10 (worst symptom)
Time frame: Changes from baseline NRS at 4 weeks are assessed
Questionnaire: widespread pain index and widespread soreness index
assessment of pain and soreness diffuseness. Score: 0(no symptom) \~19 (mostly diffused symptom)
Time frame: Change from baseline widespread index at 2 weeks are assessed
Questionnaire: widespread pain index and widespread soreness index
assessment of pain and soreness diffuseness. Score: 0(no symptom) \~19 (mostly diffused symptom)
Time frame: Change from baseline widespread index at 4 weeks are assessed
Questionnaire: Fibromyalgia impact questionnaire (FIQR)
assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) \~100 (worst symptom)
Time frame: Change from baseline FIQR at 2 weeks are assessed
Questionnaire: Fibromyalgia impact questionnaire (FIQR)
assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) \~100 (worst symptom)
Time frame: Change from baseline FIQR at 4 weeks are assessed
Questionnaire: Hospital Anxiety and Depression Scale (HADS)
assessment of psychological distress. Score: 0 (no symptom) \~42 (worst symptom)
Time frame: Change from baseline HADS at 2 weeks are assessed
Questionnaire: Hospital Anxiety and Depression Scale (HADS)
assessment of psychological distress. Score: 0 (no symptom) \~42 (worst symptom)
Time frame: Change from baseline HADS at 4 weeks are assessed
Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)
assessment of sleep quality. Score: 0 (no symptom) \~21 (worst sleep quality)
Time frame: Change from baseline PSQI at 2 weeks are assessed
Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)
assessment of sleep quality. Score: 0 (no symptom) \~21 (worst sleep quality)
Time frame: Change from baseline PSQI at 4 weeks are assessed
Questionnaire: Perceived stress scale (PSS)
assessment of perceived stress loading. Score: 0 (no stress) \~40 (highest stressed level)
Time frame: Change from baseline PSS at 2 weeks are assessed
Questionnaire: Perceived stress scale (PSS)
assessment of perceived stress loading. Score: 0 (no stress) \~40 (highest stressed level)
Time frame: Change from baseline PSS at 4 weeks are assessed
Metabolomics investigation
Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.
Time frame: Change from baseline metabolomics at 3 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: Change from baseline metabolomics at 3 months are assessed
Metabolomics investigation
Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.
Time frame: Change from baseline metabolomics at 6 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: Change from baseline metabolomics at 6 months are assessed
Metabolomics investigation
Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.
Time frame: Change from baseline metabolomics at 9 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: Change from baseline metabolomics at 9 months are assessed
Metabolomics investigation
Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.
Time frame: Change from baseline metabolomics at 12 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: Change from baseline metabolomics at 12 months are assessed
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