Bio-significance of LPC16:0 in Fibromyalgia

Kaohsiung Medical University

Status: Enrolling

Conditions: Soreness, Muscle; Metabolomics; Fibromyalgia, Primary; Oxidative Stress; Lipidomics; Pain

Treatments: Drug: Pregabalin 150mg, imipramine 25mg

Study type: Observational

Funder types: Other

Identifiers

NCT04832100

KMUHIRB-G(I)-20170012

Details and patient eligibility

About

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.

Enrollment: 245 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

245 participants in 2 patient groups

Patients with primary fibromyalgia

Description:

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 .

Treatment:

Drug: Pregabalin 150mg, imipramine 25mg

Healthy controls

Description:

Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls.