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Bio-significance of LPC16:0 in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04832100
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.


Condition or disease Intervention/treatment
Fibromyalgia, Primary Pain Soreness, Muscle Oxidative Stress Metabolomics Lipidomics Drug: Pregabalin 150mg, imipramine 25mg

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Group/Cohort Intervention/treatment
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 July 2017 to June 2022. 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.

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



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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.

  14. Lipidomics investigation [ Time Frame: Change from baseline metabolomics at 3 months are assessed ]
    Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.

  15. 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.

  16. Lipidomics investigation [ Time Frame: Change from baseline metabolomics at 6 months are assessed ]
    Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.

  17. 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.

  18. Lipidomics investigation [ Time Frame: Change from baseline metabolomics at 9 months are assessed ]
    Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.

  19. 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.

  20. Lipidomics investigation [ Time Frame: Change from baseline metabolomics at 12 months are assessed ]
    Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.


Biospecimen Retention:   Samples With DNA
collection of blood samples for metabolomic and genetic investigations


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patient group: participants with primary fibromyalgia Control group: healthy controls
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832100


Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 80756
Contact: Chih-Hsien Hung    073121101 ext 5851    jasonhung0701@hotmail.com   
Principal Investigator: Chih-Hsien Hung, MD, PhD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT04832100    
Other Study ID Numbers: KMUHIRB-G(I)-20170012
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
lysophosphotidylcholine
fibromyalgia
pain
soreness
metabolomics
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Pregabalin
Imipramine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors