The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Individuals With Fibromyalgia
CompletedNot applicableNCT07145788
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Physiotherapy-Integrated Yoga and Mindfulness Plus Home Exercise Versus Home Exercise Alone for Individuals With Fibromyalgia (PhYoMind): A Single-Blind, Parallel-Group, Randomized Controlled Trial
- Conditions
- Interventions
- Other: PhYoMind
- Other: Exercise
- Sponsor
- University Hospital Tuebingen
- Collaborators
- The Scientific and Technological Research Council of Turkey; Karl and Veronica Carstens Foundation
- Start date
- 2026-02-10
- Primary completion
- 2026-06-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Germany
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07145788