Fibromyalgia (FM) OR Fibromyalgia SyndromeNCT07769177
Efficacy of TECAR Therapy in Patients With Fibromyalgia
A study testing TECAR Therapy in people with Fibromyalgia (FM) OR Fibromyalgia Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia (FM) OR Fibromyalgia Syndrome
- What is being tested?
- TECAR Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Üniversiteler Mahallesi, Bilkent Caddesi, No: 1 (veya 6000. Cadde, No: 9) Çankaya Ankara Turkey
Ankara, 06
About this study
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.
- Being tested
- TECAR Therapy, Sham TECAR Therapy
- Keywords
- Fibromyalgia, TECAR therapy, Radiofrequency diathermy, Chronic pain, Quality of life, Sleep quality
- Medical subject headings
- Fibromyalgia, Chronic Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR TherapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TECAR Therapy | Experimental | 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 Receives: Device: TECAR Therapy |
| Sham Group | Placebo comparator | Sham TECAR therapy will be applied to the 2 most painful regions, 2 days per week for a total of 6 sessions, using 1% power in pulsed mode Receives: Device: Sham TECAR Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity
Evaluation of pain severity using Visual Analog Scale (VAS)
Measured: Baseline, immediately after the end of treatment, and 1 month after treatment
Secondary outcomes (2)
Change in Sleep Quality
Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI / PUKİ)
Measured: 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)
Measured: Baseline, immediately after treatment, and 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start7 Apr 2025
- Primary completion7 Apr 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM) OR Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SELAMI AKKUS, Prof. Dr., Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769177
- Sponsor's protocol ID
- E2-25-10719
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TECAR Therapy in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07769177
- Acronym / sponsor ID
- E2-25-10719
- Keywords
- Fibromyalgia, TECAR therapy, Radiofrequency diathermy, Chronic pain, Quality of life, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECAR Therapy | Experimental | Device: TECAR TherapyTECAR 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 Group | Placebo comparator | Device: Sham TECAR TherapySham TECAR therapy will be applied to the 2 most painful regions, 2 days per week for a total of 6 sessions, using 1% power in pulsed mode |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnancy
- Deep vein thrombosis (DVT)
- Presence of a cardiac pacemaker
- Inflammatory rheumatic diseases
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECAR TherapyTECAR 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 | Device | TECAR Therapy |
| Sham TECAR TherapySham 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. | Device | Sham Group |
Primary outcome
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)
2 secondary outcomes
Change in Sleep Quality
Time frame: Baseline, immediately after the end of treatment, and 1 month after treatment
Change in Quality of Life
Time frame: Baseline, immediately after treatment, and 1 month post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for Fibromyalgia (FM) OR Fibromyalgia Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SELAMI AKKUS, Prof. Dr. study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECAR Therapy in people with Fibromyalgia (FM) OR Fibromyalgia Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity (time frame: Baseline, immediately after the end of treatment, and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.