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

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia (FM)

• Registration Number: NCT07145788
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Study Start: 2025-11-01
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability, Fibromyalgia Impact Questionnaire (FIQ)	At baseline (Week 0) and after 8 weeks of intervention (Week 8)	The FIQ is a valid and reliable questionnaire with a total score range of 0-100 measuring overall disease severity, pain severity, physical functioning, work difficulties, morning fatigue, depression, anxiety, and general well-being rated by individuals with fibromyalgia. Higher scores indicate a greater impact of symptoms.

Secondary Outcome Measures

Name	Time	Method
Central Nervous System Assessment, Central Sensitization Inventory (CSI)	At baseline (Week 0) and after 8 weeks of intervention (Week 8)	This scale, which has a scoring system ranging from 0 to 100, consists of 25 items with a 5-point Likert type question, each of which is evaluated between 0 and 4 points. A total score of 40 and above is shown as a clinically significant cut-off value.
Autonomic Nervous System Assessment, Heart Rate Variability (HRV)	At baseline (Week 0) and after 8 weeks of intervention (Week 8)	Changes in the autonomic nervous system will be recorded by measuring heart rate variability. Heart Rate Variability (HRV) will be measured and recorded with a Polar H10 (Polar Electro UK Ltd., Warwick, UK) chest strap using the validated Elite HRV mobile application.
Current Pain Perception, The Visual Analog Scale (VAS)	At baseline (Week 0) and after 8 weeks of intervention (Week 8)	The Visual Analog Scale (VAS) scale, a widely used and valid and reliable scale, will be used to rate the pain intensity of the participants. The scale consists of a 10 cm long line, 0 "no pain"; 10 would represent "worst possible pain".
Fatique Assessment, The 20-item Multidimensional Fatigue Index (MFI)	At enrollment (Week 0) and after 8 weeks of intervention (Week 8)	To measure the severity of fatigue in participants with fibromyalgia, the 20-item Multidimensional Fatigue Index (MFI), covering various aspects of fatigue (five subscales; general fatigue, physical fatigue, mental fatigue, decreased motivation, decreased activity) will be applied. Higher score indicates more severe fatigue.
Sleep Assessment, Pittsburgh Sleep Quality Index (PSQI)	At baseline (Week 0) and after 8 weeks of intervention (Week 8)	The questionnaire consists of 19 questions grouped into seven component scores, each with a range of 0-3, including specific sleep-related problems such as average sleep duration, sleep latency, and daytime sleepiness. An overall PSQI score (range 0 to 21) is calculated. Higher scores indicate poorer sleep quality.
Stress Assessment, Perceived Stress Scale (PSS)	At baseline (Week 0) and after 8 weeks of intervention (Week 8)	This 10-item self-report scale is Likert-type and has a 5-point scoring system ranging from "never" to "very often". Higher scores were associated with higher perceived severity of stress.

Trial Locations

Locations (1)

Bosch Health Campus; 🇩🇪 Stuttgart, Auerbachstraße 112, Germany