FibromyalgiaNCT07425652
Physiotherapy Methods for Fibromyalgia
A study testing Connective tissue massage and Transcutaneous auricular vagus nerve stimulation in people with Fibromyalgia, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to examine and compare the effects of different physiotherapy methods, namely connective tissue massage, transcutaneous auricular vagus nerve stimulation and both, on pain, health status, sleep quality, fatigue, psychosocial status, autonomic symptoms and quality of life in women with… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Connective tissue massage and Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with fibromyalgia
- Being female between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- Diagnosed neurological and infectious diseases
- Uncontrolled endocrine and/or autoimmune diseases
- Serious psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.)
- Pregnancy or breastfeeding
- Malignancy
- History of known arrhythmia or any implanted electronic device
Show all 10Show fewer
- Presence of sensory loss
- Acute inflammation, open wounds, erythema in massage areas
- History of any surgery within the last 6 months
- Having received physical therapy for FM within the last 6 months and/or being included in a new treatment program during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital
Ankara, 06560
Nuriye Kayalı Sendur, +90 312 212 66 66, ankaragmkmeslekhastanesi@hs01.kep.tr
About this study
Official title: Comparison of the Effects of Different Physiotherapy Methods in Women With Fibromyalgia
The aim of our study was to examine and compare the effects of different physiotherapy methods, namely connective tissue massage, transcutaneous auricular vagus nerve stimulation and both, on pain, health status, sleep quality, fatigue, psychosocial status, autonomic symptoms and quality of life in women with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Connective tissue massage, Transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue massageOther
Connective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers
Transcutaneous auricular vagus nerve stimulationOther
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique. It targets vagus nerve stimulation through the transcutaneous application of electrical impulses to the auricle
| Study group | Role | What they receive |
|---|---|---|
| CTM Group | Experimental | Connective tissue massage (CTM) will be applied to this group 2 days a week for 6 weeks Receives: Other: Connective tissue massage |
| taVNS Group | Experimental | Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks Receives: Other: Transcutaneous auricular vagus nerve stimulation |
| CTM+taVNS Group | Experimental | Connective tissue massage (CTM) and transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks. Receives: Other: Connective tissue massage; Other: Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity as measured by the Visual Analog Scale (VAS)
In the VAS scale, which is a 10 cm scale, '0' represents no pain and '10' represents the worst imaginable pain. The distance from the marked point to the 0 point is measured using a ruler, and the pain intensity is recorded in centimeters.
Measured: Baseline, 6th week (after treatment)
Health status and disease severity as measured by the Fibromyalgia Impact Questionnaire (FIQ).
This questionnaire assesses the severity of symptoms, overall impact, and physical function. The total score for the questionnaire ranges from 0 to 100, with higher scores indicating a greater impact of the illness on patients.
Measured: Baseline, 6th week (after treatment)
Secondary outcomes (7)
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Each question is scored on a scale of 0-3, with a total score ranging from 0 to 21.
Measured: Baseline, 6th week (after treatment)
Fatigue as measured by the Visual Analog Scale (VAS).
'0' means no fatigue and '10' means unbearable fatigue. Fatigue level is recorded by measuring the distance from the marked point on the VAS (a 10 cm scale) to the 0 point using a ruler.
Measured: Baseline, 6th week (after treatment)
Depression as measured by the Beck Depression Inventory (BDI)
The BDI measures individuals' levels of depression. The scale consists of 21 items in total. Scores range from 0 to 63, with higher scores indicating higher levels of depression.
Measured: Baseline, 6th week (after treatment)
Anxiety as measured by the Beck Anxiety Inventory (BAI)
The BAI measures individuals' anxiety levels. The scale consists of 21 items in total. Scores range from 0 to 63, with higher scores indicating higher anxiety levels.
Measured: Baseline, 6th week (after treatment)
Autonomic symptoms as measured by the Composite Autonomic Symptom Score 31 (COMPASS 31)
The COMPASS-31 (Composite Autonomic Symptom Score-31) scale measures neurodegenerative system symptoms through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction
Measured: Baseline, 6th week (after treatment)
Quality of life as measured by the Nottingham Health Profile (NHP)
The NHP is a general quality of life scale that measures a person's perceived health problems and the extent to which these problems affect normal daily activities. 0 indicates the best health status, and 100 indicates the worst health status.
Measured: Baseline, 6th week (after treatment)
Compliance with the information and recommendations as measured by the Visual Analog Scale (VAS)
'0' means I did not follow any of the information and suggestions, and '10' means I followed them completely. The distance from the marked point on the VAS (a 10 cm scale) to the 0 point is measured using a ruler, and the compliance value is recorded.
Measured: 6th week (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Avcı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425652
- Sponsor's protocol ID
- 2024/034
- Other IDs
- 2865
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Physiotherapy Methods in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07425652
- Acronym / sponsor ID
- 2024/034
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Feb 2026 (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 aim of our study was to examine and compare the effects of different physiotherapy methods, namely connective tissue massage, transcutaneous auricular vagus nerve stimulation and both, on pain, health status, sleep quality, fatigue, psychosocial status, autonomic symptoms and quality of life in women with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTM Group | Experimental | Other: Connective tissue massageConnective tissue massage (CTM) will be applied to this group 2 days a week for 6 weeks |
| taVNS Group | Experimental | Other: Transcutaneous auricular vagus nerve stimulationTranscutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks |
| CTM+taVNS Group | Experimental | Other: Connective tissue massage, Other: Transcutaneous auricular vagus nerve stimulationConnective tissue massage (CTM) and transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having been diagnosed with fibromyalgia
- Being female between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (10 listed)
- Diagnosed neurological and infectious diseases
- Uncontrolled endocrine and/or autoimmune diseases
- Serious psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.)
- Pregnancy or breastfeeding
- Malignancy
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 |
|---|---|---|
| Connective tissue massageConnective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers | Other | CTM Group, CTM+taVNS Group |
| Transcutaneous auricular vagus nerve stimulationTranscutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique. It targets vagus nerve stimulation through the transcutaneous application of electrical impulses to the auricle | Other | CTM+taVNS Group, taVNS Group |
Primary outcome
Pain intensity as measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 6th week (after treatment)
In the VAS scale, which is a 10 cm scale, '0' represents no pain and '10' represents the worst imaginable pain. The distance from the marked point to the 0 point is measured using a ruler, and the pain intensity is recorded in centimeters.
Health status and disease severity as measured by the Fibromyalgia Impact Questionnaire (FIQ).
Time frame: Baseline, 6th week (after treatment)
This questionnaire assesses the severity of symptoms, overall impact, and physical function. The total score for the questionnaire ranges from 0 to 100, with higher scores indicating a greater impact of the illness on patients.
7 secondary outcomes
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 6th week (after treatment)
Fatigue as measured by the Visual Analog Scale (VAS).
Time frame: Baseline, 6th week (after treatment)
Depression as measured by the Beck Depression Inventory (BDI)
Time frame: Baseline, 6th week (after treatment)
Anxiety as measured by the Beck Anxiety Inventory (BAI)
Time frame: Baseline, 6th week (after treatment)
Autonomic symptoms as measured by the Composite Autonomic Symptom Score 31 (COMPASS 31)
Time frame: Baseline, 6th week (after treatment)
Quality of life as measured by the Nottingham Health Profile (NHP)
Time frame: Baseline, 6th week (after treatment)
Compliance with the information and recommendations as measured by the Visual Analog Scale (VAS)
Time frame: 6th week (after treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Related trials for Fibromyalgia
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
RecruitingObservational study
Respiratory Function in Fibromiyalgia Syndrome
Fibromyalgia
Not yet recruiting
Art and Mindfulness in Fibromyalgia Rehabilitation at the University Museum
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
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.
Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue massage and Transcutaneous auricular vagus nerve stimulation in people with Fibromyalgia, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Jun 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity as measured by the Visual Analog Scale (VAS) (time frame: Baseline, 6th week (after treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.