Fibromyalgia symptoms and the immune system

Autoimmunity-informed Phenotyping In patients with Fibromyalgia syndrome (APIF)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18414398

Enrollment

100

Registered

2019-03-15

Start date

2018-11-01

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Musculoskeletal Diseases Fibromyalgia syndrome (FMS)

Interventions

Eligible patients identified from Walton Centre pain registry will be approached over the telephone and provided with study information by post if agreeable. Those who are happy to participate will at

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Fibromyalgia syndrome of more than 1 year duration, without other conditions that could explain participant's widespread pain in the view of the investigator 2. ACR Fibromyalgia Criteria 2010 or 1990 3. Aged 18 years and above 4. Average weekly pain intensity of 4/10 or higher on a 11-point numeric rating scale (0-10 NRS)

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding 2. Unable to read or understand the standard questionnaires

Design outcomes

Primary

Measure	Time frame
1. Patient-reported 'ideal' temperature (i.e. the temperature at which a patients feels most comfortable with least spontaneous pain) by the researchers on interview 2. Change in symptom intensity (including spontaneous pain, pressure induced pain, sleep, fatigue, bowel symptoms, and psychological symptoms such as anxiety and depression) caused by variation in ambient temperature, recorded by the researchers on interview Unless otherwise defined, the timepoint for all outcome measures is at the clinic visit.	—

Measure

Time frame

1. Patient-reported 'ideal' temperature (i.e. the temperature at which a patients feels most comfortable with least spontaneous pain) by the researchers on interview 2. Change in symptom intensity (including spontaneous pain, pressure induced pain, sleep, fatigue, bowel symptoms, and psychological symptoms such as anxiety and depression) caused by variation in ambient temperature, recorded by the researchers on interview Unless otherwise defined, the timepoint for all outcome measures is at the clinic visit.

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Secondary

Measure	Time frame
1. Mechanical pain threshold assessed using a pressure algometer 2. Brush stroke sensitivity (intensity, ticklishness and pain on a VAS 0 to 10 and pleasantness on a VAS (-5 to +5) for both slow and fast brush strokes) 3. Patient-reported pain lingering after mechanical examination from 0 to 5 days recorded during telephone call from researcher 5-7 days after the clinic visit 4. Extent of neuropathic component to pain assessed using the painDETECT questionnaire 5. Health-related quality of life assessed using the EQ-5D questionnaire 6. Pain characteristics assessed using McGill pain questionnaire 7. Interference with life of pain assessed using the Brief Pain Inventory 8. Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS) 9. Pain catastrophising assessed using the Pain Catastrophizing Scale 10. Energy and pain intensity assessed using a a Patient-Developed Measures questionnaire 11. Ability to focus on work assessed using the Stanford Presenteeism Questionnaire 12. Security in relationships assessed using the Experiences in Close Relationships (ECR-R) questionnaire 13. Confidence in ability to conduct life activities while in pain assessed using the Pain Self Efficacy questionnaire 14. Impact of FMS symptoms assessed using the Revised Fibromyalgia Impact questionnaire (FIQR) 15. Ability to deal with emotional burdens and social interactions assessed using a daily stressors questionnaire 16. Patient-reported psychological trauma trigger for FMS by the researchers on interview 17. History of rheumatic disease in participant or first-degree relative by the researchers on interview Unless otherwise defined, the timepoint for all outcome measures is at the clinic visit.	—

Measure

Time frame

1. Mechanical pain threshold assessed using a pressure algometer 2. Brush stroke sensitivity (intensity, ticklishness and pain on a VAS 0 to 10 and pleasantness on a VAS (-5 to +5) for both slow and fast brush strokes) 3. Patient-reported pain lingering after mechanical examination from 0 to 5 days recorded during telephone call from researcher 5-7 days after the clinic visit 4. Extent of neuropathic component to pain assessed using the painDETECT questionnaire 5. Health-related quality of life assessed using the EQ-5D questionnaire 6. Pain characteristics assessed using McGill pain questionnaire 7. Interference with life of pain assessed using the Brief Pain Inventory 8. Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS) 9. Pain catastrophising assessed using the Pain Catastrophizing Scale 10. Energy and pain intensity assessed using a a Patient-Developed Measures questionnaire 11. Ability to focus on work assessed using the Stanford Presenteeism Questionnaire 12. Security in relationships assessed using the Experiences in Close Relationships (ECR-R) questionnaire 13. Confidence in ability to conduct life activities while in pain assessed using the Pain Self Efficacy questionnaire 14. Impact of FMS symptoms assessed using the Revised Fibromyalgia Impact questionnaire (FIQR) 15. Ability to deal with emotional burdens and social interactions assessed using a daily stressors questionnaire 16. Patient-reported psychological trauma trigger for FMS by the researchers on interview 17. History of rheumatic disease in participant or first-degree relative by the researchers on interview Unless otherwise defined, the timepoint for all outcome measures is at the clinic visit.

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026