The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Disability in Individuals With Fibromyalgia (PhYoMind)

University Hospital Tuebingen

Status: Not yet enrolling

Conditions: Fibromyalgia (FM)

Treatments: Other: PhYoMind; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07145788

1059B142400174 (Other Grant/Funding Number)

260/2025BO2

Details and patient eligibility

About

The current study investigates the effect of an integrative physiotherapy and mind-body programme called PhYoMind on disability in individuals with fibromyalgia (FM). Participants will be randomized to either the PhYoMind intervention, which combines specific physiotherapy techniques with yoga and mindfulness, or to a home-based exercise control group. The intervention lasts 8 weeks, with supervised and home sessions. The primary outcome is disability, with secondary outcomes including measures of central and autonomic nervous system function, pain, stress, fatigue, and sleep.

Full description

FM is a chronic disorder characterized by widespread pain, fatigue, sleep disturbances, and cognitive-emotional difficulties. Despite its high prevalence, treatment options remain limited and often focus on symptom management rather than addressing underlying physiological dysregulation. Emerging evidence implicates abnormalities in the central nervous system (CNS) and autonomic nervous system (ANS), along with neurochemical imbalances, in the development and persistence of FM symptoms.

Although physiotherapy and mind-body practices such as yoga and mindfulness have individually shown benefits for fibromyalgia symptoms, there is a lack of research on combined interventions integrating these therapies.

The present randomized controlled trial investigates the effects of PhYoMind, a novel integrative program combining physiotherapy techniques - such as Proprioceptive Neuromuscular Facilitation (PNF), Nerve Gliding Exercises (NGE), Mobility Exercises (ME), and Post-Isometric Relaxation (PIR) - with yoga and mindfulness practices. The intervention aims to improve disability and address multiple symptoms in people with FM through an integrated approach.

Participants will be randomly assigned to receive either the PhYoMind program or a home-based stretching, strengthening, and aerobic exercise regimen over 8 weeks. Two supervised sessions per week will be complemented by prescribed home exercises. Outcomes will be assessed at baseline (Week 0) and immediately after post-intervention (Week 8), including disability (primary outcome), as well as pain, stress, fatigue, sleep quality, central nervous system function and autonomic function via heart rate variability.

This study will contribute valuable evidence regarding the potential benefits of an integrative physiotherapy and mind-body approach in managing fibromyalgia symptoms.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology

Exclusion criteria

• Other important causes of pain other than FM
• If participants have hypertension; in case of changes in antihypertensive medication during the study
• Severe osteoarthritis that affects activities of daily living
• Severe somatic or psychiatric disorders
• Receiving another physiotherapy and/or physical exercise treatment concurrently with this study
• Not having sufficient cognitive level or not being able to participate in the sessions.
• Participants must either be on a stable treatment for fibromyalgia or not receiving any treatment, with no intention to alter their treatment plan during the study period. Those who do not meet this criterion will be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

PhYoMind Intervention Group

Experimental group

Description:

Physiotherapy techniques + yoga + mindfulness + home exercise

Treatment:

Other: PhYoMind

Home Exercise Group

Active Comparator group

Description:

Only Home Exercise (walking + strenghtening + streching)

Treatment:

Other: Exercise