FatiguE in Sjögren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA).

Fatigue is a prevalent and debilitating symptom of Sjögren's syndrome (SjS), affecting up to 70% of patients, with limited effective therapeutic options available. The FESSONA trial will evaluate the efficacy of combined non-pharmacological strategies, including adapted physical activity (APA), acupuncture (ACU) and transcutaneous vagus nerve stimulation (tVNS), in alleviating fatigue in SjS. This monocentric, randomised controlled trial will compare three intervention arms: APA alone, APA combined with ACU and APA combined with tVNS (with sham ACU and simulated tVNS when relevant). The primary outcome will focus on fatigue reduction, assessed by the difference in FACIT-F score between weeks 0 and 12. Secondary outcomes will include physiological and psychological fatigue-related and disease-specific measurements at both short (weeks 0 and 12) and long terms (weeks 24 and 48). A longitudinal biobank will also be established for further mechanistic studies. The trial aims to enrich clinical practice and global understanding of SjS-associated fatigue to improve its management.Trial registration number: NCT06875102.