An observational study in Fibromyalgia, Primary, Pain and Soreness, Muscle, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 245 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 291 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient group: participants with primary fibromyalgia Control group: healthy controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Clinical diagnosis of fibromyalgia
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls.
Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.
Questionnaire: Numeric rating scale (NRS) for pain and soreness
assessment of pain and soreness severity. Score: 0(no symptom) \~10 (worst symptom)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Change from baseline metabolomics at 3 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: 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.
Time frame: Change from baseline metabolomics at 6 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: 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.
Time frame: Change from baseline metabolomics at 9 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: 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.
Time frame: Change from baseline metabolomics at 12 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Time frame: Change from baseline metabolomics at 12 months are assessed
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator.
Started Jun 2021 (actual). Primary completion is estimated for Jun 2026, 60 months after the start.
Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's planned 60 months is above that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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