Bio-significance of LPC16:0 in Fibromyalgia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis),

Systemic use of corticosteroids,

Pregnancy,

Chronic diseases under poor control

Trial population

Patient group: participants with primary fibromyalgia Control group: healthy controls

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Pregabalin 150mg, imipramine 25mg

    Drug

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

Treatment groups

245 Participants
are divided into 2 treatment groups
Group A: Patients with primary fibromyalgia1 intervention
Group B: Healthy controls0 interventions

Trial outcomes

Primary outcomes

1

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 2 weeks are assessed
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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