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

NCT07145788 | Active Not Recruiting

• 3 other identifiers: 260/2025BO21059B142400174KVC 0/151/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia (FM); Chronic Pain

Keywords

Mind-Body Intervention; Fibromyalgia; chronic pain; pain management; post-isometric relaxation; proprioceptive neuromuscular facilitation; physical therapy techniques; randomized controlled trial; yoga; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (Week 0) and after 8 weeks of intervention (Week 8)

Secondary Outcomes (6)

• Central Nervous System Assessment, Central Sensitization Inventory (CSI)

  At baseline (Week 0) and after 8 weeks of intervention (Week 8)

• Autonomic Nervous System Assessment, Heart Rate Variability (HRV)

  At baseline (Week 0) and after 8 weeks of intervention (Week 8)

• Pain Perception, The Visual Analog Scale (VAS)

  At baseline (Week 0) and after 8 weeks of intervention (Week 8)

• Fatique Assessment, The 20-item Multidimensional Fatigue Index (MFI)

  At Baseline (Week 0) and after 8 weeks of intervention (Week 8)

• Sleep Assessment, Pittsburgh Sleep Quality Index (PSQI)

  At baseline (Week 0) and after 8 weeks of intervention (Week 8)

Other Outcomes (3)

• Demographic Data

  At Baseline (Week 0)

• Adverse Events

  At weeks 2, 4, 6, 8

• Adherence to the intervention

  At weeks 2, 4, 6, 8

Study Arms (2)

PhYoMind Intervention Group

EXPERIMENTAL

Physiotherapy techniques integrated with yoga and mindfulness + Home Exercise

Other: PhYoMind

Home Exercise Group

ACTIVE COMPARATOR

Only Home Exercise (walking + strenghtening + streching)

Other: Exercise

Interventions

PhYoMind OTHER

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.

PhYoMind Intervention Group

Exercise OTHER

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.

Home Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other important causes of pain other than FM
• 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
• Practicing yoga and/or mindfulness regularly
• Not having sufficient cognitive level or not being able to participate in the sessions.
• 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 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.

Sponsors & Collaborators

• Karl and Veronica Carstens Foundation: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator
• University Hospital Tuebingen: lead

Study Sites (1)

Bosch Health Campus

Stuttgart, Auerbachstraße 112, 70376, Germany

Location

Related Publications (1)

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.

  PMID: 27916278 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Agnosia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Holger Cramer, Prof. Dr.

  Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will also be conducted blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 ratio

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)