Bio-significance of LPC16:0 in Fibromyalgia

NCT04832100 | Recruiting

• 1 other identifier: KMUHIRB-G(I)-20170012
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lysophosphotidylcholine; fibromyalgia; pain; soreness; metabolomics

Outcome Measures

Primary Outcomes (20)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Lipidomics investigation

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

  Change from baseline metabolomics at 3 months are assessed

• 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

• Lipidomics investigation

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

  Change from baseline metabolomics at 6 months are assessed

• 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

• Lipidomics investigation

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

  Change from baseline metabolomics at 9 months are assessed

• 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

• Lipidomics investigation

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

  Change from baseline metabolomics at 12 months are assessed

Study Arms (2)

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 .

Drug: Pregabalin 150mg, imipramine 25mg

Healthy controls

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

Interventions

Pregabalin 150mg, imipramine 25mg DRUG

Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.

Patients with primary fibromyalgia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient group: participants with primary fibromyalgia Control group: healthy controls

You may qualify if:

• \. Clinical diagnosis of fibromyalgia

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

collection of blood samples for metabolomic and genetic investigations

MeSH Terms

Conditions

Fibromyalgia; Pain; Myalgia

Interventions

Pregabalin; Imipramine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Pain

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-03

Locations

TW (1)