Bio-significance of LPC16:0 in Fibromyalgia

June 22, 2025 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Chih-Hsien Hung, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls.
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
Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire: Numeric rating scale (NRS) for pain and soreness
Time Frame: Changes from baseline NRS at 2 weeks are assessed
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
Time Frame: Changes from baseline NRS at 4 weeks are assessed
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
Time Frame: Change from baseline widespread index at 2 weeks are assessed
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
Time Frame: Change from baseline widespread index at 4 weeks are assessed
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)
Time Frame: Change from baseline FIQR at 2 weeks are assessed
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)
Time Frame: Change from baseline FIQR at 4 weeks are assessed
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)
Time Frame: Change from baseline HADS at 2 weeks are assessed
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)
Time Frame: Change from baseline HADS at 4 weeks are assessed
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)
Time Frame: Change from baseline PSQI at 2 weeks are assessed
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)
Time Frame: Change from baseline PSQI at 4 weeks are assessed
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)
Time Frame: Change from baseline PSS at 2 weeks are assessed
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)
Time Frame: Change from baseline PSS at 4 weeks are assessed
assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level)
Change from baseline PSS at 4 weeks are assessed
Metabolomics investigation
Time Frame: Change from baseline metabolomics at 3 months are assessed
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
Time Frame: Change from baseline metabolomics at 3 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Change from baseline metabolomics at 3 months are assessed
Metabolomics investigation
Time Frame: Change from baseline metabolomics at 6 months are assessed
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
Time Frame: Change from baseline metabolomics at 6 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Change from baseline metabolomics at 6 months are assessed
Metabolomics investigation
Time Frame: Change from baseline metabolomics at 9 months are assessed
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
Time Frame: Change from baseline metabolomics at 9 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Change from baseline metabolomics at 9 months are assessed
Metabolomics investigation
Time Frame: Change from baseline metabolomics at 12 months are assessed
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
Time Frame: Change from baseline metabolomics at 12 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Change from baseline metabolomics at 12 months are assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-G(I)-20170012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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