Efficacy of TECAR Therapy in Patients With Fibromyalgia

Ankara City Hospital Bilkent46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fibromyalgia (FM) OR Fibromyalgia Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Pain Severity

Evaluation of pain severity using Visual Analog Scale (VAS)

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

Secondary Outcomes

Change in Sleep Quality

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

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

Change in Quality of Life

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

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