Physiotherapy-integrated yoga and mindfulness plus home exercise versus home exercise alone for individuals with fibromyalgia syndrome (PhYoMind): study protocol of a randomised controlled clinical trial.

backgroundFibromyalgia syndrome (FMS) is a chronic condition characterised by the presence of complex multiple symptoms, often accompanied by psychiatric comorbidities and sleep problems. The wide spectrum of symptoms and comorbid problems complicates treatment and management of the ensuing disability and symptoms. Physiotherapy approaches and mind-body practices including yoga and mindfulness are among the non-pharmacological treatment methods commonly used in FMS treatment. While there is initial evidence for these interventions, definitive conclusions about their effectiveness are still lacking and research on their combined effectiveness is limited. Therefore, this study aims to evaluate the effectiveness of a multimodal integrative protocol, the PhYoMind (PYM) intervention, which combines specific physical therapy modalities with yoga and mindfulness practices on the overall impact of fibromyalgia and functional impairment. METHODS AND ANALYSIS: This monocentric study uses a parallel-group (1:1) randomised controlled design, in which the outcome assessor and statistician are blinded to group allocation. Individuals with a clinical diagnosis of FMS (n=40) will be included in the study (Cohen's f=0.675; α=0.05; power=0.80). Participants will be randomised to receive either PYM intervention in addition to Home Exercise (HE) programme or HE programme alone. The intervention period for both groups will last 8 weeks; PYM sessions will be held twice a week for 75 min each. The primary outcome is the broad disease impact and functional impairments measured by the total score of the Fibromyalgia Impact Questionnaire. Secondary outcomes include central sensitivity, as assessed by the Central Sensitisation Index; autonomic nervous system function, as measured objectively by heart rate variability; pain perception (current, average, worst), as assessed by the Visual Analogue Scale; fatigue, as assessed by the Multidimensional Fatigue Inventory; stress, as assessed by the Perceived Stress Scale; and sleep quality as assessed by the Pittsburgh Sleep Quality Index. Adherence and adverse events will be assessed for both interventions. Repeated measures ANOVA will be used to analyse the effect of time, intervention group and their interaction on primary and secondary outcomes under an intention-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval was granted from the Ethics Committee at the Medical Faculty of Eberhard Karls Tuebingen University and at the University Hospital of Tuebingen (260/2025BO2) on 30 April 2025. The trial will be conducted in accordance with the updated principles of the Declaration of Helsinki. The study's findings will be disseminated and documented in a peer-reviewed publication, adhering to the Consolidated Standards of Reporting Trials guidelines. After completion of the study and publication of the results, participants who are interested will be offered a brief summary of the aggregated study findings. TRIAL REGISTRATION NUMBER: NCT07145788.