Pain characterization and cluster analysis in patients with connective tissue disease and fibromyalgia syndrome

Pain characterization and cluster analysis in patients with connective tissue disease and fibromyalgia syndrome - ConnectPain

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034450

Enrollment

800

Registered

2024-09-18

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Pain in patients with suspected or confirmed connective tissue diseases and/or with suspected or confirmed fibromyalgia syndrome M79.7 Q79.6 M35.7 Q87.4 Q78.0

Interventions

Group 1: Patients with a (suspected) diagnosis of connective tissue disease and/or fibromyalgia syndrome (FMS) Online survey of the following constructs Part 1: General patient characterization - Dem

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a confirmed or suspected diagnosis of a connective tissue disease (e.g. Ehlers-Danlos syndrome, hypermobility spectrum disorder, Marfan syndrome, osteogenesis imperfecta) and/or fibromyalgia syndrome

Exclusion criteria

Exclusion criteria: - Lack of consent to the survey - Age under 18 years

Design outcomes

Primary

Measure	Time frame
Cluster analysis of the pain characterization of patients with connective tissue disease and/or FMS The measurement method is an online questionnaire with 3 sub-areas: patient characterization, pain characterization and psychological pain level (see “Intervention/observation group”). Patients are asked to complete this once. The endpoint is reviewed after data collection is complete. The aim is to identify symptom clusters within the data.	—

Measure

Time frame

Cluster analysis of the pain characterization of patients with connective tissue disease and/or FMS The measurement method is an online questionnaire with 3 sub-areas: patient characterization, pain characterization and psychological pain level (see “Intervention/observation group”). Patients are asked to complete this once. The endpoint is reviewed after data collection is complete. The aim is to identify symptom clusters within the data.

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Secondary

Measure	Time frame
Time of measurement: one-time survey of the online questionnaire General for all groups - General patient characterization (e.g. demographics, main diagnoses, comorbidities, hypermobility (e.g. 5PQ), FMS criteria (FSQ)) - Symptoms of anxiety (GAD-7) and depression (PHQ-8) - Quality of life (EQ-5D-5L) - Sensitivity to pain (PSQ) - Specific pain characterization - Pain-related impairment (GCPS-R and GCPS) - Characterization of nociceptive, neuropathic and nociplastic pain - Current pain medication - Pain intensifying factors (pain catastrophizing (PCS), pain attention (PVAQ), pain acceptance (CPAQ), pain adjective/affective pain description (SBL), own control conviction) Specific endpoints for Ehlers-Danlos syndrome (EDS) and hypermobility spectrum disorder (HSD) 1) Lack of medical diagnosis as a stress factor: Comparison of EDS/HSD with suspected diagnosis vs. medically confirmed diagnosis. 2) Additional FMS with effect on disease severity: Comparison of EDS/HSD with vs. without fulfillment of FMS criteria. 3) Nociplastic symptom pattern 3a) Incidence of nociplastic pain pattern in EDS/HSD: EDS/HSD in comparison with FMS. 3b) Mediating variables and risk factors for nociplastic pain pattern: Comparison of EDS/HSD with vs. without fulfillment of nociplastic symptom pattern.	—

Measure

Time frame

Time of measurement: one-time survey of the online questionnaire General for all groups - General patient characterization (e.g. demographics, main diagnoses, comorbidities, hypermobility (e.g. 5PQ), FMS criteria (FSQ)) - Symptoms of anxiety (GAD-7) and depression (PHQ-8) - Quality of life (EQ-5D-5L) - Sensitivity to pain (PSQ) - Specific pain characterization - Pain-related impairment (GCPS-R and GCPS) - Characterization of nociceptive, neuropathic and nociplastic pain - Current pain medication - Pain intensifying factors (pain catastrophizing (PCS), pain attention (PVAQ), pain acceptance (CPAQ), pain adjective/affective pain description (SBL), own control conviction) Specific endpoints for Ehlers-Danlos syndrome (EDS) and hypermobility spectrum disorder (HSD) 1) Lack of medical diagnosis as a stress factor: Comparison of EDS/HSD with suspected diagnosis vs. medically confirmed diagnosis. 2) Additional FMS with effect on disease severity: Comparison of EDS/HSD with vs. without fulfillment of FMS criteria. 3) Nociplastic symptom pattern 3a) Incidence of nociplastic pain pattern in EDS/HSD: EDS/HSD in comparison with FMS. 3b) Mediating variables and risk factors for nociplastic pain pattern: Comparison of EDS/HSD with vs. without fulfillment of nociplastic symptom pattern.

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Countries

Germany

Contacts

Public ContactJan Wandrey

Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin

schmerzforschung@charite.de+49 30 450 531 012

Outcome results

None listed

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