An interventional study of TECAR Therapy plus Hi-EMS and Tecar therapy alone in Chronic Low-back Pain (cLBP) and Non Specific Chronic Low Back Pain, sponsored by University of Hartford. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Hartford · Not applicable, Interventional, and Treatment
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:
Researchers will compare TECAR therapy delivered with Hi-EMS to TECAR therapy delivered without Hi-EMS.
Participants will:
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.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's planned enrollment of 37 is below the median of 70 across 593 interventional studies indexed under Back Pain.
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Exclusion criteria:
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.
Device: TECAR Therapy plus Hi-EMS
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.
Device: Tecar therapy alone
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 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.
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.
Time frame: 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.
Time frame: Immediately before and immediately after each treatment session.
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.
Time frame: 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.
Time frame: Immediately before and immediately after each treatment session.
No study locations are listed for this record.
Plan to share: No — IPD sharing is not currently planned because a data-sharing process and repository have not been established for this study.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Hartford