Lumbar Disc HerniationTECAR THERAPYNCT07335718
Evaluation of the Effectiveness of Focused Radiofrequency (TECAR) Therapy on Pain, Disability, Function, and Quality of Life in Patients With Lumbar Disc Herniation
An observational study of Lumbar Disc Herniation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a very common health problem in societies, regardless of the underlying cause. Its lifetime prevalence has been reported to be as high as 75-80%. Low back pain negatively affects the quality of life of affected individuals. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- TECAR THERAPY
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 15 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients presenting to the outpatient clinic of the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital.
Who may be able to join
- Having low back pain lasting longer than 12 weeks
- Having a diagnosis of lumbar disc herniation (bulging, protruded, or extruded)
- Being able to comply with the exercise program
- Willingness to participate in the study Being between 20 and 60 years of age
Who cannot join
- Being younger than 20 years or older than 60 years
- Having a known and/or newly diagnosed malignancy
- Presence of cardiac implants such as a pacemaker
- Having inflammatory low back pain
- Having absolute spinal stenosis (anteroposterior diameter of the spinal canal < 10 mm and anteroposterior diameter of the lateral recess < 3 mm)
- History of surgery due to lumbar disc herniation, lumbar spinal stenosis, vertebral fracture, or similar conditions
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- Presence of lumbar spondylolisthesis
- Patients with sequestered disc herniation
- Patients with polyneuropathy
- Patients with central pain following stroke
- Patients with neurological deficits
- Having a diagnosed neurodegenerative disease
- Having a systemic musculoskeletal disease
- Patients with acute deep vein thrombosis
- Pregnancy
- Presence of infection at the skin surface where treatment will be applied
- Unexplained weight loss
- Bladder and/or bowel incontinence
- Having received physical therapy modalities or injections for low back pain within the last 1 month
- Having cognitive impairment
- Refusal to participate in the study
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara
ankara bilkent city hospital ankara bilkent city hospital, 0312 552 60 00, ankarasehir@saglik.gov.tr
About this study
Low back pain is a very common health problem in societies, regardless of the underlying cause. Its lifetime prevalence has been reported to be as high as 75-80%. Low back pain negatively affects the quality of life of affected individuals. In addition to diagnostic and treatment costs, it can lead to serious physical disability, resulting in loss of workforce and placing a substantial economic burden on countries. Many different factors play a role in the etiology of low back pain. According to etiology, it can be classified as idiopathic, mechanical, rheumatologic, metabolic, endocrine, infectious, neoplastic, neurologic/psychiatric disorders, and pain of visceral origin. The treatment of low back pain can be classified into medical treatment, physical therapy, percutaneous invasive interventions, and surgical intervention. TECAR therapy is also one of the treatment modalities routinely used in clinical practice. Our aim is to develop more effective physical therapy programs.
Read the detailed description
The study is planned as a prospective, randomized, double-blind trial. According to power analysis, 54 patients will be included to achieve 95% power. Eligible participants will be women or men aged 20-60 years who are diagnosed with lumbar disc herniation, have low back pain lasting longer than 12 weeks, present to the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, and consent to participate in the study.
According to the study criteria, initial evaluations will be performed by a single Physical Medicine and Rehabilitation physician. Demographic data of eligible patients, including age, sex, height, weight, occupation, and systemic diseases, will be recorded.
Patients will be evaluated before treatment, immediately after treatment, and one month after the end of treatment using the following scales: Visual Analog Scale (VAS) for pain, Numeric Rating Scale (NRS), Quality of Life Scale (SF-36), Roland-Morris Disability Questionnaire, Oswestry Disability Index, Finger-to-Floor Distance Measurement, Beck Depression Inventory, and Lumbar Schober Test.
Patients will be divided into two groups. The first group will receive a home exercise program including lumbar active range of motion exercises and lumbar isometric strengthening exercises, performed five times per week for three weeks according to the level of movement restriction and pain severity, along with TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
The second group will receive the same home exercise program-including lumbar active range of motion exercises and lumbar isometric strengthening exercises-performed five times per week for three weeks according to the level of movement restriction and pain severity, along with sham TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
- Conditions
- Lumbar Disc Herniation
- Being tested
- TECAR THERAPY
- Keywords
- Lumbar Disc Herniation, TECAR Therapy, Pain
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR THERAPYDevice
TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions
TECAR TherapyDevice
TECAR therapy is a new and effective treatment modality.
| Study group | Role | What they receive |
|---|---|---|
| TECAR Therapy | Patients with lumbar disc herniation Receives: Device: TECAR THERAPY | |
| sham TECAR Therapy | Patients with lumbar disc herniation Receives: Device: TECAR Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Zero indicates no pain at all, whereas ten represents the most severe pain imaginable.
Measured: Up to 1 month after the end of treatment
Secondary outcomes (1)
Oswestry Disability Index
The Oswestry Disability Index (ODI) is a standardized questionnaire designed to assess the degree of disability and functional impairment in individuals with lower back pain
Measured: Up to 1 month after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Saymaz, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335718
- Sponsor's protocol ID
- TABED 1-24-833
- Acronym
- TECAR THERAPY
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I am undecided because the study is currently ongoing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Focused Radiofrequency (TECAR) Therapy on Pain, Disability, Function, and Quality of Life in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07335718
- Acronym / sponsor ID
- TECAR THERAPY / TABED 1-24-833
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar Disc Herniation, TECAR Therapy, Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 13 Jan 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.
Low back pain is a very common health problem in societies, regardless of the underlying cause. Its lifetime prevalence has been reported to be as high as 75-80%. Low back pain negatively affects the quality of life of affected individuals. In addition to diagnostic and treatment costs, it can lead to serious physical disability, resulting in loss of workforce and placing a substantial economic burden on countries. Many different factors play a role in the etiology of low back pain. According to etiology, it can be classified as idiopathic, mechanical, rheumatologic, metabolic, endocrine, infectious, neoplastic, neurologic/psychiatric disorders, and pain of visceral origin. The treatment of low back pain can be classified into medical treatment, physical therapy, percutaneous invasive interventions, and surgical intervention. TECAR therapy is also one of the treatment modalities routinely used in clinical practice. Our aim is to develop more effective physical therapy programs.
Detailed description
The study is planned as a prospective, randomized, double-blind trial. According to power analysis, 54 patients will be included to achieve 95% power. Eligible participants will be women or men aged 20-60 years who are diagnosed with lumbar disc herniation, have low back pain lasting longer than 12 weeks, present to the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, and consent to participate in the study.
According to the study criteria, initial evaluations will be performed by a single Physical Medicine and Rehabilitation physician. Demographic data of eligible patients, including age, sex, height, weight, occupation, and systemic diseases, will be recorded.
Patients will be evaluated before treatment, immediately after treatment, and one month after the end of treatment using the following scales: Visual Analog Scale (VAS) for pain, Numeric Rating Scale (NRS), Quality of Life Scale (SF-36), Roland-Morris Disability Questionnaire, Oswestry Disability Index, Finger-to-Floor Distance Measurement, Beck Depression Inventory, and Lumbar Schober Test.
Patients will be divided into two groups. The first group will receive a home exercise program including lumbar active range of motion exercises and lumbar isometric strengthening exercises, performed five times per week for three weeks according to the level of movement restriction and pain severity, along with TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
The second group will receive the same home exercise program-including lumbar active range of motion exercises and lumbar isometric strengthening exercises-performed five times per week for three weeks according to the level of movement restriction and pain severity, along with sham TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECAR Therapy | – | Device: TECAR THERAPYPatients with lumbar disc herniation |
| sham TECAR Therapy | – | Device: TECAR TherapyPatients with lumbar disc herniation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients presenting to the outpatient clinic of the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital.
Key inclusion criteria (4 listed)
- Having low back pain lasting longer than 12 weeks
- Having a diagnosis of lumbar disc herniation (bulging, protruded, or extruded)
- Being able to comply with the exercise program
- Willingness to participate in the study Being between 20 and 60 years of age
Key exclusion criteria (22 listed)
- Being younger than 20 years or older than 60 years
- Having a known and/or newly diagnosed malignancy
- Presence of cardiac implants such as a pacemaker
- Having inflammatory low back pain
- Having absolute spinal stenosis (anteroposterior diameter of the spinal canal < 10 mm and anteroposterior diameter of the lateral recess < 3 mm)
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 applied by a technician for 20 minutes per session, three days per week, for a total of six sessions | Device | TECAR Therapy |
| TECAR TherapyTECAR therapy is a new and effective treatment modality. | Device | sham TECAR Therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Up to 1 month after the end of treatment
Zero indicates no pain at all, whereas ten represents the most severe pain imaginable.
1 secondary outcome
Oswestry Disability Index
Time frame: Up to 1 month after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided. I am undecided because the study is currently ongoing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, 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 4 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 13 Jan 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cemre y yılmaz (0312 552 60 00, saymazcemre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Up to 1 month after the end of 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 13 Jan 2026.