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Clinical Trials/NCT04832100
NCT04832100
Recruiting
Not Applicable

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country245 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Pregabalin 150mg, imipramine 25mg
Conditions
Fibromyalgia, Primary
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
245
Locations
1
Primary Endpoint
Questionnaire: widespread pain index and widespread soreness index
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
June 30, 2027
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of fibromyalgia

Exclusion Criteria

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

Arms & Interventions

Patients with primary fibromyalgia

Adults with complaints of chronic widespread pain at the outpatient department of KMUH were consecutively enrolled over a 5-year period from June 2021 to June 2026. Participants were interviewed by experienced neurologists , and those who fulfilled the 2011 American College of Rheumatology (ACR) criteria for FM were recruited .

Intervention: Pregabalin 150mg, imipramine 25mg

Outcomes

Primary Outcomes

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)

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)

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)

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.

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)

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)

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)

Lipidomics investigation

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

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

Study Sites (1)

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