Physiotherapy Methods for Fibromyalgia

June 13, 2026 updated by: Beyza Avcı, Ankara Yildirim Beyazıt University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having been diagnosed with fibromyalgia
  • Being female between the ages of 18-65
  • Volunteering to participate in the study

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CTM Group
Connective tissue massage (CTM) will be applied to this group 2 days a week for 6 weeks
Other: Connective tissue massage
Connective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers
Experimental: taVNS Group
Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks
Other: Transcutaneous auricular vagus nerve stimulation
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
Experimental: CTM+taVNS Group
Connective tissue massage (CTM) and transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks.
Other: Connective tissue massage
Connective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers
Other: Transcutaneous auricular vagus nerve stimulation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6th week (after treatment)
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.
Baseline, 6th week (after treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 6th week (after treatment)
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.
Baseline, 6th week (after treatment)
Fatigue as measured by the Visual Analog Scale (VAS).
Time Frame: Baseline, 6th week (after treatment)
'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.
Baseline, 6th week (after treatment)
Depression as measured by the Beck Depression Inventory (BDI)
Time Frame: Baseline, 6th week (after treatment)
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.
Baseline, 6th week (after treatment)
Anxiety as measured by the Beck Anxiety Inventory (BAI)
Time Frame: Baseline, 6th week (after treatment)
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.
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)
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
Baseline, 6th week (after treatment)
Quality of life as measured by the Nottingham Health Profile (NHP)
Time Frame: Baseline, 6th week (after treatment)
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.
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)
'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.
6th week (after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/034 (University of Health Sciences Scientific Research Projects Unit)
  • 2865 (Other Identifier: Ankara Yıldırım Beyazıt University Scientific Research Projects Coordination Unit)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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