Fibromyalgia, PrimaryNCT04832100
Bio-significance of LPC16:0 in Fibromyalgia
An observational study of Fibromyalgia, Primary and Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, Primary, Pain, Soreness, Muscle
- What is being tested?
- Pregabalin 150mg, imipramine 25mg
- How many people
- 245 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patient group: participants with primary fibromyalgia Control group: healthy controls
Who may be able to join
- 1. Clinical diagnosis of fibromyalgia
Who cannot join
- Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis),
- Systemic use of corticosteroids,
- Pregnancy,
- Chronic diseases under poor control
- Malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 80756
Chih-Hsien Hung, 073121101 ext. 5851, jasonhung0701@hotmail.com
Chih-Hsien Hung, MD, PhD
About this study
Official title: 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.
- Conditions
- Fibromyalgia, Primary, Pain, Soreness, Muscle, Oxidative Stress, Metabolomics, Lipidomics
- Being tested
- Pregabalin 150mg, imipramine 25mg
- Keywords
- lysophosphotidylcholine, fibromyalgia, pain, soreness, metabolomics
- Medical subject headings
- Fibromyalgia, Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mg, imipramine 25mgDrug
Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Drug: Pregabalin 150mg, imipramine 25mg | |
| Healthy controls | Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire: Numeric rating scale (NRS) for pain and soreness
assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Change from baseline metabolomics at 3 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Measured: 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.
Measured: Change from baseline metabolomics at 6 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Measured: 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.
Measured: Change from baseline metabolomics at 9 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Measured: 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.
Measured: Change from baseline metabolomics at 12 months are assessed
Lipidomics investigation
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Measured: Change from baseline metabolomics at 12 months are assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832100
- Sponsor's protocol ID
- KMUHIRB-G(I)-20170012
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator.
Publications
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.
PubMed 36918228
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia
- ClinicalTrials.gov ID
- NCT04832100
- Acronym / sponsor ID
- KMUHIRB-G(I)-20170012
- Conditions
- Fibromyalgia, Primary, Pain, Soreness, Muscle, Oxidative Stress, Metabolomics, Lipidomics
- Keywords
- lysophosphotidylcholine, fibromyalgia, pain, soreness, metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with primary fibromyalgia | – | Drug: Pregabalin 150mg, imipramine 25mgAdults 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 . |
| Healthy controls | – | –Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient group: participants with primary fibromyalgia Control group: healthy controls
Key inclusion criteria (1 listed)
- 1. Clinical diagnosis of fibromyalgia
Key exclusion criteria (5 listed)
- Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis),
- Systemic use of corticosteroids,
- Pregnancy,
- Chronic diseases under poor control
- Malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 150mg, imipramine 25mgConventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then. | Drug | Patients with primary fibromyalgia |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Lipidomics investigation
Time frame: Change from baseline metabolomics at 3 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
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.
Lipidomics investigation
Time frame: Change from baseline metabolomics at 6 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
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.
Lipidomics investigation
Time frame: Change from baseline metabolomics at 9 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
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.
Lipidomics investigation
Time frame: Change from baseline metabolomics at 12 months are assessed
Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 36918228Hung 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.
- Individual participant dataSharing planned: Undecided. Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, Primary and Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire: Numeric rating scale (NRS) for pain and soreness (time frame: Changes from baseline NRS at 2 weeks are assessed). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.