Bio-significance of LPC16:0 in Fibromyalgia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832100
• Other study ID #: KMUHIRB-G(I)-20170012
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: July 31, 2027

Study information

• Verified date: October 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia, Primary
• Lipidomics
• Metabolomics
• Myalgia
• Myofascial Pain Syndromes
• Oxidative Stress
• Pain
• Soreness, Muscle

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire: Numeric rating scale (NRS) for pain and soreness	assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom)	Changes from baseline NRS at 2 weeks are assessed
Primary	Questionnaire: Numeric rating scale (NRS) for pain and soreness	assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom)	Changes from baseline NRS at 4 weeks are assessed
Primary	Questionnaire: widespread pain index and widespread soreness index	assessment of pain and soreness diffuseness. Score: 0(no symptom) ~19 (mostly diffused symptom)	Change from baseline widespread index at 2 weeks are assessed
Primary	Questionnaire: widespread pain index and widespread soreness index	assessment of pain and soreness diffuseness. Score: 0(no symptom) ~19 (mostly diffused symptom)	Change from baseline widespread index at 4 weeks are assessed
Primary	Questionnaire: Fibromyalgia impact questionnaire (FIQR)	assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) ~100 (worst symptom)	Change from baseline FIQR at 2 weeks are assessed
Primary	Questionnaire: Fibromyalgia impact questionnaire (FIQR)	assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) ~100 (worst symptom)	Change from baseline FIQR at 4 weeks are assessed
Primary	Questionnaire: Hospital Anxiety and Depression Scale (HADS)	assessment of psychological distress. Score: 0 (no symptom) ~42 (worst symptom)	Change from baseline HADS at 2 weeks are assessed
Primary	Questionnaire: Hospital Anxiety and Depression Scale (HADS)	assessment of psychological distress. Score: 0 (no symptom) ~42 (worst symptom)	Change from baseline HADS at 4 weeks are assessed
Primary	Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)	assessment of sleep quality. Score: 0 (no symptom) ~21 (worst sleep quality)	Change from baseline PSQI at 2 weeks are assessed
Primary	Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)	assessment of sleep quality. Score: 0 (no symptom) ~21 (worst sleep quality)	Change from baseline PSQI at 4 weeks are assessed
Primary	Questionnaire: Perceived stress scale (PSS)	assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level)	Change from baseline PSS at 2 weeks are assessed
Primary	Questionnaire: Perceived stress scale (PSS)	assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level)	Change from baseline PSS at 4 weeks are assessed
Primary	Metabolomics investigation	Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.	Change from baseline metabolomics at 3 months are assessed
Primary	Lipidomics investigation	Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.	Change from baseline metabolomics at 3 months are assessed
Primary	Metabolomics investigation	Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.	Change from baseline metabolomics at 6 months are assessed
Primary	Lipidomics investigation	Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.	Change from baseline metabolomics at 6 months are assessed
Primary	Metabolomics investigation	Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.	Change from baseline metabolomics at 9 months are assessed
Primary	Lipidomics investigation	Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.	Change from baseline metabolomics at 9 months are assessed
Primary	Metabolomics investigation	Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.	Change from baseline metabolomics at 12 months are assessed
Primary	Lipidomics investigation	Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.	Change from baseline metabolomics at 12 months are assessed