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Recruiting NCT07425652

Physiotherapy Methods for Fibromyalgia

No phase Interventional Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Connective tissue massage, Transcutaneous auricular vagus nerve stimulation.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of the Effects of Different Physiotherapy Methods in Women With Fibromyalgia

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Pain intensity as measured by the Visual Analog Scale (VAS) [Time frame: 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)]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital — Ankara

Identifiers

NCT: NCT07425652 · 2024/034 · 2865

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗