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Completed

NCT Number: NCT07769177

Efficacy of TECAR Therapy in Patients With Fibromyalgia

A total of 46 patients aged 18-65 years diagnosed with fibromyalgia according to the 2016 ACR criteria, whose most painful region was axial (neck, back, or lower back), were included in the study and randomly assigned upon admission into treatment ($n=23$) and sham control ($n=23$) groups. The treatment group received real TECAR therapy using the BTL-6000 TR Therapy Pro device for a total of 6 sessions over 3 weeks at a frequency of 2 days per week (each 30-minute session consisting of 10 minutes of capacitive and 5 minutes of resistive modes applied to each of the 2 most painful regions), while the control group underwent the exact same protocol applied as sham therapy at 1% power in pulsed mode.

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Key information

Conditions

Fibromyalgia (FM) OR Fibromyalgia Syndrome Chronic Pain Dyssomnias Fibromyalgia Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Üniversiteler Mahallesi, Bilkent Caddesi, No: 1 (veya 6000. Cadde, No: 9) Çankaya Ankara Turkey

Ankara, 06, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 65 years
  • Diagnosed with fibromyalgia syndrome (FMS) according to the 2016 American College of Rheumatology (ACR) diagnostic criteria
  • Willing and able to provide written informed consent

Exclusion criteria

  • Pregnancy
  • Deep vein thrombosis (DVT)
  • Presence of a cardiac pacemaker
  • Inflammatory rheumatic diseases
  • Psychiatric disorders
  • Medical or physical therapy treatment for fibromyalgia (FM) within the last 3 months
  • Skin conditions in the application area
  • History of active malignancy or malignancy within the past year, and ongoing chemotherapy and/or radiotherapy
  • Active infection or coagulation disorders
  • Uncontrolled or severe cardiovascular or metabolic disorders
  • Significant disc herniation, radiculopathy, myelopathy, or neurological deficit

Treatment and study plan

TECAR Therapy

Device

TECAR therapy will be applied to the 2 most painful regions, 2 days per week for a total of 6 sessions. Each session will consist of 10 minutes of capacitive mode followed by 5 minutes of resistive mode

Sham TECAR therapy

Device

Sham TECAR therapy will be applied to ionizing/similar protocol to the 2 most painful regions, 2 days per week for a total of 6 sessions, using 1% power in pulsed mode.

Primary outcomes

  1. Change in Pain Severity

    Time frame: Baseline, immediately after the end of treatment, and 1 month after treatment

    Evaluation of pain severity using Visual Analog Scale (VAS)

Secondary outcomes

  1. Change in Sleep Quality

    Time frame: Baseline, immediately after the end of treatment, and 1 month after treatment

    Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI / PUKİ)

  2. Change in Quality of Life

    Time frame: Baseline, immediately after treatment, and 1 month post-treatment

    Evaluation of quality of life and functional status using the Short Form-36 (SF-36)

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 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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