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

N/AActive Not RecruitingNCT07145788

University Hospital Tuebingen40 enrolled

Overview

The current study investigates the effect of an integrative physiotherapy and mind-body program called PhYoMind intervention on disability and symptoms 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 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 perception, stress, fatigue, and sleep quality. Adverse events and adherence of the intervention will be also assessed.

FM is a chronic disorder characterized by widespread pain, fatigue, sleep disturbances, and autonomic/central nervous system dysfunction. Despite its high prevalence, treatment options remain limited and often focus on symptom management rather than addressing underlying dysregulation. Emerging evidence also implicates abnormalities in the central nervous system (CNS) and autonomic nervous system (ANS) in the development and persistence of FM symptoms. Although physiotherapy and mind-body interventions including 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 and complementary program combining physiotherapy techniques in particular, 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 this integrated program. Participants will be randomly assigned to receive either the PhYoMind program or a home exercises including stretching, strengthening, and aerobic exercises 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 perception, stress, fatigue, sleep quality, central/autonomic nervous system function. In addition, adverse events and adherence of the intervention will be assessed. This study will contribute valuable evidence regarding the potential benefits of an integrated physiotherapy and mind-body interventions in managing fibromyalgia symptoms.

Study Type

INTERVENTIONAL

Interventions

PhYoMindOTHER

This integrative intervention method includes some specific physiotherapy techniques, ( e. g. self proprioceptive neuromuscular facilitation, self nerve gliding, self mobility, post isometric relaxation techniques) yoga postures, left nostril breathing, humming bee breathing and mindfulness practices. Each session will be 75 minutes and focus on different parts of the body and yoga postures will be selected according to these focused areas. For each week, a specific body area will be chosen as the focus. For example, the first week will focus on the hip area and lower extremities, the second week on the upper body and upper extremities, the third week on the core and anterior line of the body, and the fourth week on the back and posterior line of the body and this sequence will continue through the eighth week. In addition to these sessions, participants in this group will also apply home exercises (aerobic+strenghtening+streching) twice a week, 60 minutes per practice.

ExerciseOTHER

The control group will receive only home exercises twice a week. Big muscle groups strengthening and stretching exercises and walking planned for the patient will be given as home exercise. The walking exercise will last 30 minutes at a moderately fast pace, depending on the subject's adaptation. The strengthening exercises will last 15 minutes and will consist of 3 sets of 12 repetitions of exercises with body weight and light weights, generally targeting the back extensor muscles, core stabilization muscles, shoulder region muscles in the upper extremity and hip and knee joint muscles in the lower extremity. The stretching exercises will last 15 minutes and will include neck muscles, pectoralis major/minor, erector spina, hamstrings, quadriceps femoris muscles 1-2 times for 30 seconds each. Participants will be taught face to face with a brochure when they come for the first assessment and will be asked to do HE at home.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology Exclusion Criteria: * Other serious illnesses causing severe pain and complicating participation in the study * Receiving another physiotherapy treatment concurrently with this study * Regular practice of yoga and/or mindfulness exercises prior to the study * History of acute myocardial infarction or heart failure and resulting cardiac capacity limitations. * Uncontrolled hypertension (resting systolic/diastolic blood pressure ≥160/100 mmHg) * Current treatment with medications known to significantly affect HRV (e.g. beta-blockers or antiarrhythmic drugs) * Pregnancy or planned pregnancy during the study period * Severe psychiatric disorders or insufficient cognitive abilities resulting in inability to participate in the study * Participants must either be on a stable treatment for FMS or not receiving any treatment, with no intention to alter their treatment plan during the study period. (Any unintended changes in fibromyalgia-related medications or other treatments during the study will be recorded and documented).

Outcomes

Primary Outcomes

Disability, Fibromyalgia Impact Questionnaire (FIQ)

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.