Bio-significance of LPC16:0 in Fibromyalgia

NCT ID: NCT04832100

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2027-06-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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 .

Pregabalin 150mg, imipramine 25mg

Intervention Type: DRUG

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

Healthy controls

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

No interventions assigned to this group

Interventions

Pregabalin 150mg, imipramine 25mg

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Chih-Hsien Hung

Role: primary

jasonhung0701@hotmail.com

073121101 ext. 5851

References

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.

Reference Type: DERIVED

PMID: 36918228 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KMUHIRB-G(I)-20170012

Identifier Type: -

Identifier Source: org_study_id