Health TrialsbyHealthPanel

TECAR Therapy in Chronic Back Pain

ConditionsChronic Low-back Pain (cLBP)Non Specific Chronic Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of Hartford

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

spinal fracture

tumor

radiculopathy

neurological or vascular condition

Trial design

Design model

Crossover

Treatments tested in this trial

  • TECAR Therapy plus Hi-EMS

    Device

    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 alone

    Device

    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.

Treatment groups

37 Participants
are divided into 2 treatment groups
Group A: TECAR Therapy Plus Hi-EMSExperimental treatment 1 intervention
Group B: TECAR Therapy AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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.

Secondary outcomes

1

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.
2

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hartford

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: