Lumbal Disc HerniationLDH-TECARNCT07082660
Tecar Therapy in Lumbar Disc Herniation
A study testing High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR) and Lumbal Stabilization Exercise Program in people with Lumbal Disc Herniation and Capacitive and Resistive Electric Transfer Therapy, run by Şebnem Nur Alkan at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effects of Tecar therapy on pain intensity and functional status in patients with lumbar disc herniation. The intervention group received Tecar therapy combined with conventional physiotherapy, while the control group received only conventional physiotherapy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbal Disc Herniation, Capacitive and Resistive Electric Transfer Therapy, Exercise Training
- What is being tested?
- High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR) and Lumbal Stabilization Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 20 May 2023
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 20-60 years
- diagnosed with low back pain
- pain localized between L1 and L5
- having low back pain lasting for more than 3 months [24].
Who cannot join
- having sensory disturbances
- muscle weakness, or reflex loss identified during motor, sensory, or reflex examinations
- history of prior lumbal spine surgery or vertebral fractures
- presence of electronic medical devices such as pacemakers or other implants contraindicated for electrical stimulation or high-frequency diathermy therapy
- patients officially registered as disabled or receiving social benefits due to low back pain, severe osteoporosis, osteomalacia, malignancy, infectious diseases, or systemic musculoskeletal or rheumatological disorders,
- pregnancy,
- cardiovascular conditions preventing exercise, or viscerogenic causes of low back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial On Lumbal Disc Herniation Using Tecar Therapy: Effects On Pain And Functionality
This randomized controlled trial investigates the effects of Tecar therapy on pain intensity and functional status in patients with lumbar disc herniation. The intervention group received Tecar therapy combined with conventional physiotherapy, while the control group received only conventional physiotherapy. Outcome measures include pain intensity, lumbar mobility, and functional disability. The study aims to determine whether Tecar therapy provides additional benefits compared to standard care in the early rehabilitation of individuals with lumbar disc herniation.
Read the detailed description
Background Lumbar disc herniation (LDH) is a prevalent musculoskeletal condition that can significantly impair quality of life due to pain and functional limitations. Rehabilitation strategies often include lumbar stabilization exercises, and adjunct electrotherapies such as capacitive-resistive diathermy (TECAR) have gained interest for their potential therapeutic effects.
Purpose This randomized controlled trial aims to evaluate the effects of adding high-frequency capacitive-resistive diathermic current (TECAR) therapy to lumbar stabilization exercises, compared to lumbar stabilization exercises alone, on pain intensity, functional status, and lumbar range of motion in individuals with chronic LDH.
Methods
Thirty participants with chronic LDH (duration >6 months) and no neurological deficits will be randomly assigned to one of two intervention groups:
TECAR + Exercise Group (TEG, n=15): Participants will receive 12 sessions of TECAR therapy (20 minutes, 3 sessions per week) in combination with lumbar stabilization exercises over 4 weeks.
Exercise Group (EG, n=15): Participants will receive only lumbar stabilization exercises with the same frequency and duration.
Outcome measures will include:
Pain intensity (Visual Analog Scale - VAS)
Functional status (Oswestry Disability Index - ODI)
Lumbar range of motion (goniometry)
All evaluations will be performed pre- and post-intervention by a physiotherapist who is blinded to group allocation.
- Conditions
- Lumbal Disc Herniation, Capacitive and Resistive Electric Transfer Therapy, Exercise Training
- Being tested
- High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR), Lumbal Stabilization Exercise Program
- Keywords
- Lumbal disk herniation, Capasitive and resistive electric transfer therapy, exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR)Device
20 minutes per session, 3 times per week for 4 weeks
Lumbal Stabilization Exercise ProgramBehavioural
3 sessions per week for 4 weeks, each session includes core stabilization and lumbar control exercises (12 sessions total).
| Study group | Role | What they receive |
|---|---|---|
| TECAR Therapy Combined with Lumbal Stabilization Exercises | Experimental | Participants in this group will receive high-frequency capacitive-resistive diathermic current (TECAR) therapy (20 minutes per session, 3 sessions/week for 4 weeks) in addition to a lumbal stabilization exercise program (12 sessions total). Receives: Device: High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR) |
| Lumbal Stabilization Exercises Only | Active comparator | Participants in this group will receive only the lumbal stabilization exercise program, 3 sessions/week for 4 weeks (12 sessions total), with no TECAR therapy applied. Receives: Behavioral: Lumbal Stabilization Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar functionality
The Oswestry Disability Index (ODI), validated Turkish version, will be used to assess disability related to low back pain. The scale consists of 10 items, each scored from 0 to 5, with a total maximum score of 50. The total score is converted into a percentage using the formula: (total obtained score / maximum possible score) × 100. Scores range from 0% to 100%, where higher scores indicate greater disability. Interpretation categories are as follows: 0%-20% indicates minimal disability; 21%-40% indicates moderate disability; 41%-60% indicates severe disability; 61%-80% indicates crippled; and 81%-100% indicates bed-bound status or possible symptom exaggeration.
Measured: Baseline - 4 weeks
Secondary outcomes (1)
Pain intensity
The Visual Analog Scale (VAS) will be used to assess pain intensity. It consists of a 10-centimeter horizontal line representing a continuum from 'no pain' (0) to 'worst imaginable pain' (10). Participants are asked to mark a point on the line that corresponds to the intensity of their pain. The distance in centimeters from the 'no pain' anchor to the participant's mark is measured and recorded as the VAS score. Scores range from 0 to 10, with higher scores indicating greater pain severity.
Measured: Baseline - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jan 2023
- Primary completion30 Mar 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbal Disc HerniationStudies of the same condition, open and under way.
- 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
- Model description
- Participants were randomly assigned to two parallel groups receiving either TECAR + lumbar stabilization or lumbar stabilization only.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şebnem Nur Alkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şebnem Nur Alkan, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082660
- Sponsor's protocol ID
- ETTBI-LDH-2023-01
- Acronym
- LDH-TECAR
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the article (after deidentification) will be shared with other researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial On Lumbal Disc Herniation Using Tecar Therapy: Effects On Pain And Functionality
- ClinicalTrials.gov ID
- NCT07082660
- Acronym / sponsor ID
- LDH-TECAR / ETTBI-LDH-2023-01
- Conditions
- Lumbal Disc Herniation, Capacitive and Resistive Electric Transfer Therapy, Exercise Training
- Keywords
- Lumbal disk herniation, Capasitive and resistive electric transfer therapy, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Şebnem Nur AlkanUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 24 Jul 2025 (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.
This randomized controlled trial investigates the effects of Tecar therapy on pain intensity and functional status in patients with lumbar disc herniation. The intervention group received Tecar therapy combined with conventional physiotherapy, while the control group received only conventional physiotherapy. Outcome measures include pain intensity, lumbar mobility, and functional disability. The study aims to determine whether Tecar therapy provides additional benefits compared to standard care in the early rehabilitation of individuals with lumbar disc herniation.
Detailed description
Background Lumbar disc herniation (LDH) is a prevalent musculoskeletal condition that can significantly impair quality of life due to pain and functional limitations. Rehabilitation strategies often include lumbar stabilization exercises, and adjunct electrotherapies such as capacitive-resistive diathermy (TECAR) have gained interest for their potential therapeutic effects.
Purpose This randomized controlled trial aims to evaluate the effects of adding high-frequency capacitive-resistive diathermic current (TECAR) therapy to lumbar stabilization exercises, compared to lumbar stabilization exercises alone, on pain intensity, functional status, and lumbar range of motion in individuals with chronic LDH.
Methods
Thirty participants with chronic LDH (duration >6 months) and no neurological deficits will be randomly assigned to one of two intervention groups:
TECAR + Exercise Group (TEG, n=15): Participants will receive 12 sessions of TECAR therapy (20 minutes, 3 sessions per week) in combination with lumbar stabilization exercises over 4 weeks.
Exercise Group (EG, n=15): Participants will receive only lumbar stabilization exercises with the same frequency and duration.
Outcome measures will include:
Pain intensity (Visual Analog Scale - VAS)
Functional status (Oswestry Disability Index - ODI)
Lumbar range of motion (goniometry)
All evaluations will be performed pre- and post-intervention by a physiotherapist who is blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two parallel groups receiving either TECAR + lumbar stabilization or lumbar stabilization only.
| Arm | Type | Receives |
|---|---|---|
| TECAR Therapy Combined with Lumbal Stabilization Exercises | Experimental | Device: High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR)Participants in this group will receive high-frequency capacitive-resistive diathermic current (TECAR) therapy (20 minutes per session, 3 sessions/week for 4 weeks) in addition to a lumbal stabilization exercise program (12 sessions total). |
| Lumbal Stabilization Exercises Only | Active comparator | Behavioral: Lumbal Stabilization Exercise ProgramParticipants in this group will receive only the lumbal stabilization exercise program, 3 sessions/week for 4 weeks (12 sessions total), with no TECAR therapy applied. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 20-60 years
- diagnosed with low back pain
- pain localized between L1 and L5
- having low back pain lasting for more than 3 months [24].
Key exclusion criteria (7 listed)
- having sensory disturbances
- muscle weakness, or reflex loss identified during motor, sensory, or reflex examinations
- history of prior lumbal spine surgery or vertebral fractures
- presence of electronic medical devices such as pacemakers or other implants contraindicated for electrical stimulation or high-frequency diathermy therapy
- patients officially registered as disabled or receiving social benefits due to low back pain, severe osteoporosis, osteomalacia, malignancy, infectious diseases, or systemic musculoskeletal or rheumatological 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 |
|---|---|---|
| High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR)20 minutes per session, 3 times per week for 4 weeks | Device | TECAR Therapy Combined with Lumbal Stabilization Exercises |
| Lumbal Stabilization Exercise Program3 sessions per week for 4 weeks, each session includes core stabilization and lumbar control exercises (12 sessions total). | Behavioural | Lumbal Stabilization Exercises Only |
Primary outcome
Lumbar functionality
Time frame: Baseline - 4 weeks
The Oswestry Disability Index (ODI), validated Turkish version, will be used to assess disability related to low back pain. The scale consists of 10 items, each scored from 0 to 5, with a total maximum score of 50. The total score is converted into a percentage using the formula: (total obtained score / maximum possible score) × 100. Scores range from 0% to 100%, where higher scores indicate greater disability. Interpretation categories are as follows: 0%-20% indicates minimal disability; 21%-40% indicates moderate disability; 41%-60% indicates severe disability; 61%-80% indicates crippled; and 81%-100% indicates bed-bound status or possible symptom exaggeration.
1 secondary outcome
Pain intensity
Time frame: Baseline - 4 weeks
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 24 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the article (after deidentification) will be shared with other researchers upon reasonable request.
Related trials for Lumbal Disc Herniation
Enrolling by invitation
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Lumbar Disc Disease, Lumbal Disc Herniation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR) and Lumbal Stabilization Exercise Program in people with Lumbal Disc Herniation and Capacitive and Resistive Electric Transfer Therapy, run by Şebnem Nur Alkan 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 7 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 24 Jul 2025. 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?
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?
Lumbar functionality (time frame: Baseline - 4 weeks). 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 24 Jul 2025.