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Recruiting NCT04832100

Bio-significance of LPC16:0 in Fibromyalgia

— Observational Fibromyalgia, Primary Pain Soreness, Muscle Oxidative Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pregabalin 150mg, imipramine 25mg.
Who it may be relevant to
Registry conditions: Fibromyalgia, Primary, Pain, Soreness, Muscle, Oxidative Stress. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Pregabalin 150mg, imipramine 25mg
    Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.

Primary outcome measures

  • Questionnaire: Numeric rating scale (NRS) for pain and soreness [Time frame: Changes from baseline NRS at 2 weeks are assessed]
  • Questionnaire: Numeric rating scale (NRS) for pain and soreness [Time frame: Changes from baseline NRS at 4 weeks are assessed]
  • Questionnaire: widespread pain index and widespread soreness index [Time frame: Change from baseline widespread index at 2 weeks are assessed]
  • Questionnaire: widespread pain index and widespread soreness index [Time frame: Change from baseline widespread index at 4 weeks are assessed]
  • Questionnaire: Fibromyalgia impact questionnaire (FIQR) [Time frame: Change from baseline FIQR at 2 weeks are assessed]
  • Questionnaire: Fibromyalgia impact questionnaire (FIQR) [Time frame: Change from baseline FIQR at 4 weeks are assessed]
  • Questionnaire: Hospital Anxiety and Depression Scale (HADS) [Time frame: Change from baseline HADS at 2 weeks are assessed]
  • Questionnaire: Hospital Anxiety and Depression Scale (HADS) [Time frame: Change from baseline HADS at 4 weeks are assessed]
  • Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Change from baseline PSQI at 2 weeks are assessed]
  • Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Change from baseline PSQI at 4 weeks are assessed]

Eligibility criteria

Inclusion criteria

1\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University Hospital — Kaohsiung City

Publications

  • Hung CH, Tsai MH, Wang PS, Liang FW, Hsu CY, Lee KW, Fong YO, Han DS, Lee CH, Lai CL, Chen CC. Oxidative stress involves phenotype modulation of morbid soreness symptoms in fibromyalgia. RMD Open. 2023 Mar;9(1):e002741. doi: 10.1136/rmdopen-2022-002741. PMID 36918228

Identifiers

NCT: NCT04832100 · KMUHIRB-G(I)-20170012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗