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

What this Trial Is About

Fibromyalgia is a common chronic pain disorder that causes widespread muscle pain along with symptoms like fatigue, sleep problems, cognitive issues, and anxiety or depression. This study evaluates fibromyalgia and related symptoms using tailored questionnaires and explores the biological role of a specific lipid, LPC16:0, which previous research suggests may be involved in fibromyalgia pain and could serve as a diagnostic biomarker. Adults with fibromyalgia meeting standard criteria and healthy adults without pain are enrolled over five years. Patients receive conventional treatments such as Pregabalin and Imipramine and undergo clinical follow-ups. The study uses questionnaires to assess pain, soreness, anxiety, depression, sleep quality, and stress at 2 and 4 weeks, alongside metabolomic and lipidomic tests at 3, 6, 9, and 12 months to investigate biological changes. Participants will attend interviews and complete multiple questionnaires to track symptom changes over time. Researchers will monitor biological markers in blood samples and assess questionnaire results to understand fibromyalgia's pathophysiology better. The study runs through June 2027, aiming to validate the clinical significance of LPC16:0 as a biomarker for fibromyalgia.

Bio-significance of LPC16:0 in Fibromyalgia