Fibromyalgia (FM)PhYoMindNCT07145788
The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Individuals With Fibromyalgia
A study testing PhYoMind and Exercise in people with Fibromyalgia (FM) and Chronic Pain, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM), Chronic Pain
- What is being tested?
- PhYoMind and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology
Who cannot join
- 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)
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia (FM), Chronic Pain
- Being tested
- PhYoMind, Exercise
- Keywords
- Mind-Body Intervention, Fibromyalgia, chronic pain, pain management, post-isometric relaxation, proprioceptive neuromuscular facilitation, physical therapy techniques, randomized controlled trial, yoga, mindfulness
- Medical subject headings
- Fibromyalgia, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PhYoMind Intervention Group | Experimental | Physiotherapy techniques integrated with yoga and mindfulness + Home Exercise Receives: Other: PhYoMind |
| Home Exercise Group | Active comparator | Only Home Exercise (walking + strenghtening + streching) Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Secondary outcomes (6)
Central Nervous System Assessment, Central Sensitization Inventory (CSI)
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.
Measured: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Autonomic Nervous System Assessment, Heart Rate Variability (HRV)
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.
Measured: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Pain Perception, The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) scale, a widely used and valid and reliable scale, will be used to rate the current, average, worst pain intensity of the participants over the last week.The scale consists of a 10 cm long line, 0 "no pain"; 10 would represent "worst possible pain".
Measured: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Fatique Assessment, The 20-item Multidimensional Fatigue Index (MFI)
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.
Measured: At Baseline (Week 0) and after 8 weeks of intervention (Week 8)
Sleep Assessment, Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Stress Assessment, Perceived Stress Scale (PSS)
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.
Measured: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start10 Feb 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Karl and Veronica Carstens Foundation
- Responsible party
- Sponsor
- Investigators
- Holger Cramer, Prof. Dr., Principal investigator, Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145788
- Sponsor's protocol ID
- 260/2025BO2
- Other IDs
- 1059B142400174, KVC 0/151/2025
- Acronym
- PhYoMind
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and the data dictionary will be made available upon reasonable request.
Publications
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.
PubMed 27916278Sarak Kucukosmanoglu H, Aytar A, Bilc MI, Anheyer D, N V Kieninger A, Alaze A, Cramer H. Physiotherapy-integrated yoga and mindfulness plus home exercise versus home exercise alone for individuals with fibromyalgia syndrome (PhYoMind): study protocol of a randomised controlled clinical trial. BMJ Open. 2026 Jul 6;16(7):e120248. doi: 10.1136/bmjopen-2026-120248.
PubMed 42409395
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07145788
- Acronym / sponsor ID
- PhYoMind / 260/2025BO2
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Karl and Veronica Carstens Foundation
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| PhYoMind Intervention Group | Experimental | Other: PhYoMindPhysiotherapy techniques integrated with yoga and mindfulness + Home Exercise |
| Home Exercise Group | Active comparator | Other: ExerciseOnly Home Exercise (walking + strenghtening + streching) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhYoMindThis 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. | Other | PhYoMind Intervention Group |
| ExerciseThe 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. | Other | Home Exercise Group |
Primary outcome
Disability, Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 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.
6 secondary outcomes
Central Nervous System Assessment, Central Sensitization Inventory (CSI)
Time frame: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Autonomic Nervous System Assessment, Heart Rate Variability (HRV)
Time frame: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Pain Perception, The Visual Analog Scale (VAS)
Time frame: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Fatique Assessment, The 20-item Multidimensional Fatigue Index (MFI)
Time frame: At Baseline (Week 0) and after 8 weeks of intervention (Week 8)
Sleep Assessment, Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Stress Assessment, Perceived Stress Scale (PSS)
Time frame: At baseline (Week 0) and after 8 weeks of intervention (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 27916278Wolfe 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.
- Derived from this study: PubMed 42409395Sarak Kucukosmanoglu H, Aytar A, Bilc MI, Anheyer D, N V Kieninger A, Alaze A, Cramer H. Physiotherapy-integrated yoga and mindfulness plus home exercise versus home exercise alone for individuals with fibromyalgia syndrome (PhYoMind): study protocol of a randomised controlled clinical trial. BMJ Open. 2026 Jul 6;16(7):e120248. doi: 10.1136/bmjopen-2026-120248.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and the data dictionary will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Cramer, Prof. Dr. principal investigator
Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhYoMind and Exercise in people with Fibromyalgia (FM) and Chronic Pain, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability, Fibromyalgia Impact Questionnaire (FIQ) (time frame: At baseline (Week 0) and after 8 weeks of intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.