TECAR Therapy in Chronic Back Pain
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?
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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Richard Liebano, PhD
- Telefonní číslo: 860-768-8419
- E-mail: liebano@hartford.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: TECAR Therapy Plus Hi-EMS
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.
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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.
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Aktivní komparátor: TECAR Therapy Alone
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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain intensity at rest
Časové okno: Immediately before and immediately after each treatment session
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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.
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Immediately before and immediately after each treatment session
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Movement-Evoked Pain Intensity
Časové okno: Immediately before and immediately after each treatment session.
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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.
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Immediately before and immediately after each treatment session.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pressure pain threshold
Časové okno: Immediately before and immediately after each treatment session.
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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.
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Immediately before and immediately after each treatment session.
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Five-Times-Sit-to-Stand Test
Časové okno: Immediately before and immediately after each treatment session.
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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.
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Immediately before and immediately after each treatment session.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Tecar and Back Pain
Plán pro data jednotlivých účastníků (IPD)
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