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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

March 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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