TECAR Therapy in Chronic Back Pain

NCT07821021 | Not Yet Recruiting

• 1 other identifier: Tecar and Back Pain
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Chronic Low-back Pain (cLBP); Non Specific Chronic Low Back Pain

Keywords

TECAR; electrical stimulation; back pain; heat; thermotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately before and immediately after each treatment session.

Secondary Outcomes (2)

• Pressure pain threshold

  Immediately before and immediately after each treatment session.

• Five-Times-Sit-to-Stand Test

  Immediately before and immediately after each treatment session.

Study Arms (2)

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.

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.

Device: Tecar therapy alone

Interventions

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 Plus Hi-EMS

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.

TECAR Therapy Alone

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• spinal fracture
• tumor
• radiculopathy
• neurological or vascular condition
• pregnancy
• cardiac pacemaker or other implanted device
• 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

Sponsors & Collaborators

• University of Hartford: lead

MeSH Terms

Conditions

Back Pain; Hyperthermia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Richard Liebano, PhD

CONTACT

860-768-8419; liebano@hartford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): February 9, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share