NCT07425652

Brief 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 fibromyalgia.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

February 11, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 11, 2026

Last Update Submit

February 15, 2026

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline, 6th week (after treatment)

Secondary Outcomes (7)

  • Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)

    Baseline, 6th week (after treatment)

  • Fatigue as measured by the Visual Analog Scale (VAS).

    Baseline, 6th week (after treatment)

  • Depression as measured by the Beck Depression Inventory (BDI)

    Baseline, 6th week (after treatment)

  • Anxiety as measured by the Beck Anxiety Inventory (BAI)

    Baseline, 6th week (after treatment)

  • Autonomic symptoms as measured by the Composite Autonomic Symptom Score 31 (COMPASS 31)

    Baseline, 6th week (after treatment)

  • +2 more secondary outcomes

Study Arms (3)

CTM Group

EXPERIMENTAL

Connective tissue massage (CTM) will be applied to this group 2 days a week for 6 weeks

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

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.

Other: Connective tissue massageOther: Transcutaneous auricular vagus nerve stimulation

Interventions

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

CTM GroupCTM+taVNS Group
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

CTM+taVNS GrouptaVNS Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physiotherapist and PhD Candidate

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02