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NCT Number: NCT07425652

Physiotherapy Methods for 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital

Ankara, 06560, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nuriye Kayalı Sendur

CONTACT

[email protected]

+90 312 212 66 66

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Connective Tissue Massage

Other

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 Stimulation

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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