Biological, psychological and social markers of fibromyalgia syndrome

Lymphocyte µ opioid receptors as an innovative biomarker for fibromyalgia: a biological, psychological and social study for fibromyalgia diagnosis, therapy and rehabilitation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN24645566

Enrollment

140

Registered

2018-12-10

Start date

2018-03-08

Completion date

Unknown

Last updated

2026-02-16

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

Conditions

Fibromyalgia Signs and Symptoms Fibromyalgia

Interventions

All participants with fibromyalgia (FM) will undergo a clinical examination, with a tender points (TP) count and blood sampling. Blood sample (20ml) will be taken from both FM patients and the control

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with fibromyalgia, according to both 1990 and 2010 ACR criteria 2. Aged 18-65 years

Exclusion criteria

Exclusion criteria: Patients who are treated with opioids

Design outcomes

Primary

Measure	Time frame
The following are assessed at the first clinical visit (between 0-12 months): 1. Gene expression analysis of the µ opioid receptor, assessed using real-time PCR using blood samples 2. Protein expression analysis of the µ opioid receptor, assessed using Western blotting using blood samples 3. Immunophenotype of the µ opioid receptor, assessed using blood samples 4. Functional receptor analysis, assessed using ELISA using blood samples	—

Measure

Time frame

The following are assessed at the first clinical visit (between 0-12 months): 1. Gene expression analysis of the µ opioid receptor, assessed using real-time PCR using blood samples 2. Protein expression analysis of the µ opioid receptor, assessed using Western blotting using blood samples 3. Immunophenotype of the µ opioid receptor, assessed using blood samples 4. Functional receptor analysis, assessed using ELISA using blood samples

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Secondary

Measure	Time frame
Psychological endpoints The following are assessed at the first clinical visit (0-12 months): 1. Fibromyalgia status, progress and outcomes, assessed using the Fibromyalgia Impact Questionnaire (FIQ) 2. Fatigue, sleep disturbances and pain, assessed using the FIbromyalgia Assessment Status (FAS) 3. Health status, assessed using the Health Assessment Questionnaire (HAQ) 4. Perceptions of illness, assessed using the Illness Perception Questionnaire-Revised (IPQ-R) 5. Coping strategies, assessed using the Coping Strategies Questionnaire-Revised (CSQ) 6. Depression, anxiety and stress, assessed using the Depression Anxiety and Stress Scale 21 (DASS-21) 7. Acceptance of pain, assessed using the Chronic Pain Acceptance Questionnaire (CPAQ) 8. Hypochondriasis and hysteria, assessed using the Hypochondriasis (Hs) and Hysteria (Hy) scales of the Minnesota Multiphasic Personality Inventory 2 (MMPI-2) respectively Anthropological endpoints Analysis of individual elaboration process of pain and disease, in order to identify the elements that occur more frequently in the illness narratives, will be assessed using the McGill Illness Narrative Interview (MINI). These interviews will be conducted during 3-18 months of the study.	—

Measure

Time frame

Psychological endpoints The following are assessed at the first clinical visit (0-12 months): 1. Fibromyalgia status, progress and outcomes, assessed using the Fibromyalgia Impact Questionnaire (FIQ) 2. Fatigue, sleep disturbances and pain, assessed using the FIbromyalgia Assessment Status (FAS) 3. Health status, assessed using the Health Assessment Questionnaire (HAQ) 4. Perceptions of illness, assessed using the Illness Perception Questionnaire-Revised (IPQ-R) 5. Coping strategies, assessed using the Coping Strategies Questionnaire-Revised (CSQ) 6. Depression, anxiety and stress, assessed using the Depression Anxiety and Stress Scale 21 (DASS-21) 7. Acceptance of pain, assessed using the Chronic Pain Acceptance Questionnaire (CPAQ) 8. Hypochondriasis and hysteria, assessed using the Hypochondriasis (Hs) and Hysteria (Hy) scales of the Minnesota Multiphasic Personality Inventory 2 (MMPI-2) respectively Anthropological endpoints Analysis of individual elaboration process of pain and disease, in order to identify the elements that occur more frequently in the illness narratives, will be assessed using the McGill Illness Narrative Interview (MINI). These interviews will be conducted during 3-18 months of the study.

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026