Chronic Low-back Pain (cLBP)NCT07821021
TECAR Therapy in Chronic Back Pain
A study testing TECAR Therapy plus Hi-EMS and Tecar therapy alone in people with Chronic Low-back Pain (cLBP) and Non Specific Chronic Low Back Pain, run by University of Hartford.
Trial summary
The goal of this clinical trial is to learn whether adding high-intensity electromyostimulation (Hi-EMS) to capacitive and resistive electric transfer (TECAR) therapy improves pain and functional performance in adults with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP), Non Specific Chronic Low Back Pain
- What is being tested?
- TECAR Therapy plus Hi-EMS and Tecar therapy alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 9 Feb 2027
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 21 to 60 years old
- chronic nonspecific low back pain
- minimum pain intensity of 3 on a 0-10 scale
- be able to provide consent and comply with study procedures
Who cannot join
- spinal fracture
- tumor
- radiculopathy
- neurological or vascular condition
- pregnancy
- cardiac pacemaker or other implanted device
Show all 14Show fewer
- skin disorder or allergy
- altered sensation in the treatment area
- active or recent hemorrhage
- cognitive impairments
- liniments or heat rubs immediately before a study session
- treatment for low back within the previous 6 weeks
- currently receiving disability benefits because of low back pain
- current or pending litigation related to low back pain
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Investigation Into the Short-term Effects of Capacitive and Resistive Electrical Transfer Therapy Alone Versus Combined With Electrical Stimulation in Chronic Low Back Pain.
The goal of this clinical trial is to learn whether adding high-intensity electromyostimulation (Hi-EMS) to capacitive and resistive electric transfer (TECAR) therapy improves pain and functional performance in adults with chronic nonspecific low back pain. The main questions it aims to answer are:
- Does adding Hi-EMS to TECAR therapy reduce low back pain at rest?
- Does adding Hi-EMS reduce pain during the Five-Times-Sit-to-Stand Test?
- Does adding Hi-EMS improve pressure pain threshold and performance on the - Five-Times-Sit-to-Stand Test?
Read more
Researchers will compare TECAR therapy delivered with Hi-EMS to TECAR therapy delivered without Hi-EMS.
Participants will:
- Receive both treatment conditions in a randomized order
- Wait one week between treatment sessions
- Receive 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer during each session
- Receive Hi-EMS during the 10-minute resistive electrical transfer phase in one of the sessions
- Complete pain, pressure pain threshold, and functional performance assessments immediately before and after each session
Read the detailed description
Capacitive and resistive electric transfer (TECAR) therapy is a radiofrequency-based electrothermal modality designed to generate endogenous tissue heating. Preliminary evidence suggests that TECAR therapy may provide short-term improvements in pain and disability in individuals with low back pain. Some TECAR devices also incorporate a manufacturer-specific electrical stimulation function known as high-intensity electromyostimulation (Hi-EMS). However, the additional effects of combining Hi-EMS with TECAR therapy have not been established.
This randomized, assessor-blinded crossover trial will investigate whether adding Hi-EMS to TECAR therapy produces greater immediate improvements in pain and functional performance than TECAR therapy alone in individuals with chronic nonspecific low back pain. Each participant will receive both treatment conditions in a randomized order, allowing participants to serve as their own controls. The treatment sessions will be separated by a one-week washout period.
The study will evaluate immediate within-session responses and compare the magnitude of change between the two treatment conditions. The findings will help determine whether the concurrent use of Hi-EMS provides additional short-term benefits beyond those produced by TECAR therapy alone.
- Being tested
- TECAR Therapy plus Hi-EMS, Tecar therapy alone
- Keywords
- TECAR, electrical stimulation, back pain, heat, thermotherapy
- Medical subject headings
- Back Pain, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR Therapy plus Hi-EMSDevice
TECAR therapy will be delivered using the BACK4 system (Winback Europa SAS, Biarritz, France). The intervention will consist of 10 minutes of capacitive electrical transfer (CET) followed by 10 minutes of resistive electrical transfer (RET). A conductive cream will be applied to the treatment area, and a return plate will be positioned over the abdomen. The Hi-EMS Focal mode will be activated only during the 10-minute RET phase and adjusted to produce a strong but comfortable stimulation without pain or excessive discomfort.
Tecar therapy aloneDevice
TECAR therapy will be delivered using the BACK4 system (Winback Europa SAS, Biarritz, France). The intervention will consist of 10 minutes of capacitive electrical transfer (CET) followed by followed by 10 minutes of resistive electrical transfer (RET). A conductive cream will be applied to the treatment area, and a return plate will be positioned over the abdomen. Hi-EMS will not be activated during this condition.
| Study group | Role | What they receive |
|---|---|---|
| TECAR Therapy Plus Hi-EMS | Experimental | Participants will receive TECAR therapy with concurrent Hi-EMS. The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer, with Hi-EMS delivered only during the 10-minute resistive electrical transfer phase. Receives: Device: TECAR Therapy plus Hi-EMS |
| TECAR Therapy Alone | Active comparator | Participants will receive TECAR therapy without Hi-EMS. The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer. Receives: Device: Tecar therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest
Low back pain intensity at rest will be assessed using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will rate their current low back pain while at rest before performing the functional test. Higher scores indicate greater pain intensity.
Measured: Immediately before and immediately after each treatment session
Movement-Evoked Pain Intensity
Movement-evoked low back pain intensity will be assessed immediately after the Five-Times-Sit-to-Stand Test using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will rate the greatest low back pain experienced while performing the test. Higher scores indicate greater pain intensity.
Measured: Immediately before and immediately after each treatment session.
Secondary outcomes (2)
Pressure pain threshold
A computerized digital pressure algometer (AlgoMed, Medoc Ltd.) with a 1-cm² probe will assess lumbar pressure pain threshold (PPT). Pressure will be applied at 40 kPa/s, and participants will press a response button when the sensation first becomes painful. PPT will be measured three times bilaterally at sites 5 cm lateral to the L3 and L5 spinous processes, with 30-second intervals. The measurements will be averaged to obtain a single lumbar PPT value at each assessment.
Measured: Immediately before and immediately after each treatment session.
Five-Times-Sit-to-Stand Test
Functional performance will be assessed using the Five-Times-Sit-to-Stand Test. Participants will be instructed to complete five consecutive sit-to-stand repetitions as quickly and safely as possible. The time required to complete five repetitions will be measured using a stopwatch. The test will be performed twice, and the mean completion time of the two trials will be used for analysis.
Measured: Immediately before and immediately after each treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies 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
- Crossover
- Model description
- Participants will receive both treatment conditions in a randomized order in a two-treatment, two-period crossover design. Treatment sessions will be separated by a one-week washout period. Participants will serve as their own controls.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Liebano, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821021
- Sponsor's protocol ID
- Tecar and Back Pain
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not currently planned because a data-sharing process and repository have not been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Short-term Effects of Capacitive and Resistive Electrical Transfer Therapy Alone Versus Combined With Electrical Stimulation in Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT07821021
- Acronym / sponsor ID
- Tecar and Back Pain
- Keywords
- TECAR, electrical stimulation, back pain, heat, thermotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Feb 2027 (estimated)
- First posted
- 15 Sep 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.
The goal of this clinical trial is to learn whether adding high-intensity electromyostimulation (Hi-EMS) to capacitive and resistive electric transfer (TECAR) therapy improves pain and functional performance in adults with chronic nonspecific low back pain. The main questions it aims to answer are:
- Does adding Hi-EMS to TECAR therapy reduce low back pain at rest?
- Does adding Hi-EMS reduce pain during the Five-Times-Sit-to-Stand Test?
- Does adding Hi-EMS improve pressure pain threshold and performance on the - Five-Times-Sit-to-Stand Test?
Researchers will compare TECAR therapy delivered with Hi-EMS to TECAR therapy delivered without Hi-EMS.
Participants will:
- Receive both treatment conditions in a randomized order
- Wait one week between treatment sessions
- Receive 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer during each session
- Receive Hi-EMS during the 10-minute resistive electrical transfer phase in one of the sessions
- Complete pain, pressure pain threshold, and functional performance assessments immediately before and after each session
Detailed description
Capacitive and resistive electric transfer (TECAR) therapy is a radiofrequency-based electrothermal modality designed to generate endogenous tissue heating. Preliminary evidence suggests that TECAR therapy may provide short-term improvements in pain and disability in individuals with low back pain. Some TECAR devices also incorporate a manufacturer-specific electrical stimulation function known as high-intensity electromyostimulation (Hi-EMS). However, the additional effects of combining Hi-EMS with TECAR therapy have not been established.
This randomized, assessor-blinded crossover trial will investigate whether adding Hi-EMS to TECAR therapy produces greater immediate improvements in pain and functional performance than TECAR therapy alone in individuals with chronic nonspecific low back pain. Each participant will receive both treatment conditions in a randomized order, allowing participants to serve as their own controls. The treatment sessions will be separated by a one-week washout period.
The study will evaluate immediate within-session responses and compare the magnitude of change between the two treatment conditions. The findings will help determine whether the concurrent use of Hi-EMS provides additional short-term benefits beyond those produced by TECAR therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive both treatment conditions in a randomized order in a two-treatment, two-period crossover design. Treatment sessions will be separated by a one-week washout period. Participants will serve as their own controls.
| Arm | Type | Receives |
|---|---|---|
| TECAR Therapy Plus Hi-EMS | Experimental | Device: TECAR Therapy plus Hi-EMSParticipants will receive TECAR therapy with concurrent Hi-EMS. The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer, with Hi-EMS delivered only during the 10-minute resistive electrical transfer phase. |
| TECAR Therapy Alone | Active comparator | Device: Tecar therapy aloneParticipants will receive TECAR therapy without Hi-EMS. The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 21 to 60 years old
- chronic nonspecific low back pain
- minimum pain intensity of 3 on a 0-10 scale
- be able to provide consent and comply with study procedures
Key exclusion criteria (14 listed)
- spinal fracture
- tumor
- radiculopathy
- neurological or vascular condition
- pregnancy
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 Therapy plus Hi-EMSTECAR therapy will be delivered using the BACK4 system (Winback Europa SAS, Biarritz, France). The intervention will consist of 10 minutes of capacitive electrical transfer (CET) followed by 10 minutes of resistive electrical transfer (RET). A conductive cream will be applied to the treatment area, and a return plate will be positioned over the abdomen. The Hi-EMS Focal mode will be activated only during the 10-minute RET phase and adjusted to produce a strong but comfortable stimulation without pain or excessive discomfort. | Device | TECAR Therapy Plus Hi-EMS |
| Tecar therapy aloneTECAR therapy will be delivered using the BACK4 system (Winback Europa SAS, Biarritz, France). The intervention will consist of 10 minutes of capacitive electrical transfer (CET) followed by followed by 10 minutes of resistive electrical transfer (RET). A conductive cream will be applied to the treatment area, and a return plate will be positioned over the abdomen. Hi-EMS will not be activated during this condition. | Device | TECAR Therapy Alone |
Primary outcome
Pain intensity at rest
Time frame: Immediately before and immediately after each treatment session
Low back pain intensity at rest will be assessed using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will rate their current low back pain while at rest before performing the functional test. Higher scores indicate greater pain intensity.
Movement-Evoked Pain Intensity
Time frame: Immediately before and immediately after each treatment session.
Movement-evoked low back pain intensity will be assessed immediately after the Five-Times-Sit-to-Stand Test using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will rate the greatest low back pain experienced while performing the test. Higher scores indicate greater pain intensity.
2 secondary outcomes
Pressure pain threshold
Time frame: Immediately before and immediately after each treatment session.
Five-Times-Sit-to-Stand Test
Time frame: Immediately before and immediately after each treatment session.
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 15 Sep 2026.
- Individual participant dataSharing planned: No. IPD sharing is not currently planned because a data-sharing process and repository have not been established for this study.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TECAR Therapy plus Hi-EMS and Tecar therapy alone in people with Chronic Low-back Pain (cLBP) and Non Specific Chronic Low Back Pain, run by University of Hartford.
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 14 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Richard Liebano, PhD (860-768-8419, liebano@hartford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at rest (time frame: Immediately before and immediately after each treatment session). The study lists 2 primary outcomes in all. 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 15 Sep 2026.