Social Support and Biomarkers in Fibromyalgia Syndrome (FMS)

Social Support and Biomarkers in Fibromyalgia Syndrome (FMS) - FMS-Resolution

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039368

Enrollment

225

Registered

2026-02-27

Start date

2026-03-04

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

M79.7

Interventions

Group 1: We have followed a cohort of patients with fibromyalgia syndrome (FMS) for more than 10 years. For many participants, long-term follow-up data (=5 years) are available. Based on changes in th

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 and older with CRPS (male/female) or FMS (female). Healthy control subjects.

Exclusion criteria

Exclusion criteria: Serious other medical condition that would prevent participation in the study. For microneurography (MNG) and skin biopsy: bleeding disorder. For MNG and MRI: pacemaker or internal defibrillator, pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the resolution or clinical improvement of fibromyalgia syndrome (FMS). Resolution is defined as a reduction of the Fibromyalgia Impact Questionnaire (FIQ) score by = 50%, and improvement as a reduction by = 30%, together with the associated change in the systemic cytokine profile. This parameter will be assessed by comparing the initial examination (baseline at the first clinical visit), two to three follow-up assessments during long-term follow-up (= 5 years), and the current examination conducted as part of the present study. Clinical status will be assessed using the FIQ. In parallel, serum cytokines and chemokines will be measured using the ELLA® system. Additionally, serum Neurofilament Light Chain (NfL) will be determined as a marker of axonal degeneration.	—

Measure

Time frame

The primary endpoint is the resolution or clinical improvement of fibromyalgia syndrome (FMS). Resolution is defined as a reduction of the Fibromyalgia Impact Questionnaire (FIQ) score by = 50%, and improvement as a reduction by = 30%, together with the associated change in the systemic cytokine profile. This parameter will be assessed by comparing the initial examination (baseline at the first clinical visit), two to three follow-up assessments during long-term follow-up (= 5 years), and the current examination conducted as part of the present study. Clinical status will be assessed using the FIQ. In parallel, serum cytokines and chemokines will be measured using the ELLA® system. Additionally, serum Neurofilament Light Chain (NfL) will be determined as a marker of axonal degeneration.

—

Secondary

Measure	Time frame
Secondary endpoints include subjective pain intensity, which is assessed multiple times per day during the one-week Ecological Momentary Assessment (EMA) and Ecological Momentary Intervention (EMI) phase, as well as comorbidities, neuropathic pain symptoms, overall pain burden, and depressive symptoms, all evaluated at the current study visit using various questionnaires. In addition, intraepidermal nerve fiber density (IENFD) is determined once via a skin biopsy with immunohistochemical analysis, while spontaneous activity and excitability of C-nociceptors are examined once using microneurography with electrical, mechanical, and thermal stimulation. Morphology and function of the dorsal root ganglia are assessed once by magnetic resonance imaging (MRI). Finally, autoantibody profiles and the reactivity of peripheral immune cells are evaluated.	—

Measure

Time frame

Secondary endpoints include subjective pain intensity, which is assessed multiple times per day during the one-week Ecological Momentary Assessment (EMA) and Ecological Momentary Intervention (EMI) phase, as well as comorbidities, neuropathic pain symptoms, overall pain burden, and depressive symptoms, all evaluated at the current study visit using various questionnaires. In addition, intraepidermal nerve fiber density (IENFD) is determined once via a skin biopsy with immunohistochemical analysis, while spontaneous activity and excitability of C-nociceptors are examined once using microneurography with electrical, mechanical, and thermal stimulation. Morphology and function of the dorsal root ganglia are assessed once by magnetic resonance imaging (MRI). Finally, autoantibody profiles and the reactivity of peripheral immune cells are evaluated.

—

Countries

Germany

Contacts

Public ContactClaudia Sommer

Universitätsklinikum Würzburg

claudia.sommer@uni-wuerzburg.de+49 931 201 23697

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026