Fibromyalgia (FM) OR Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia, TECAR therapy, Radiofrequency diathermy, Chronic pain, Quality of life, Sleep quality
Brief summary
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.
Interventions
DEVICETECAR Therapy
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
DEVICESham TECAR Therapy
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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Severity | Baseline, immediately after the end of treatment, and 1 month after treatment | Evaluation of pain severity using Visual Analog Scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality | Baseline, immediately after the end of treatment, and 1 month after treatment | Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI / PUKİ) |
| Change in Quality of Life | Baseline, immediately after treatment, and 1 month post-treatment | Evaluation of quality of life and functional status using the Short Form-36 (SF-36) |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORSELAMI AKKUS, Prof. Dr.
Ankara Yildirim Beyazıt University
Outcome results
None listed