Bio-significance of LPC16:0 in Fibromyalgia

Recruiting

• Conditions: Metabolomics; Lipidomics; Fibromyalgia, Primary; Soreness, Muscle; Oxidative Stress; Pain
• Interventions: Drug: Pregabalin 150mg, imipramine 25mg

• Registration Number: NCT04832100
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Study Start: 2021-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-14
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with primary fibromyalgia	Pregabalin 150mg, imipramine 25mg	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 .

Primary Outcome Measures

Name	Time	Method
Questionnaire: widespread pain index and widespread soreness index	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)	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)	Change from baseline PSS at 4 weeks are assessed	assessment of perceived stress loading. Score: 0 (no stress) \~40 (highest stressed level)
Metabolomics investigation	Change from baseline metabolomics at 12 months are assessed	Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.
Questionnaire: Numeric rating scale (NRS) for pain and soreness	Changes from baseline NRS at 4 weeks are assessed	assessment of pain and soreness severity. Score: 0(no symptom) \~10 (worst symptom)
Questionnaire: Hospital Anxiety and Depression Scale (HADS)	Change from baseline HADS at 4 weeks are assessed	assessment of psychological distress. Score: 0 (no symptom) \~42 (worst symptom)
Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)	Change from baseline PSQI at 4 weeks are assessed	assessment of sleep quality. Score: 0 (no symptom) \~21 (worst sleep quality)
Lipidomics investigation	Change from baseline metabolomics at 12 months are assessed	Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan