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Transcutaneous Electric Nerve StimulationNCT05345015

High Frequency RF Current Effects on Muscle Pain and Function

A study testing Radiofrequency Energy Transfer and Transcutaneous Nerve Stimulation in people with Transcutaneous Electric Nerve Stimulation and Chronic Low-back Pain, run by Aristotle University Of Thessaloniki at 2 sites in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Radiofrequency Energy Transfer and Transcutaneous Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesGreece
Study dates
1 Sep 2022to 31 Dec 2029
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years.
  • Athletes: amateur soccer players or sprinters with regular, systematic training.
  • Suspected Grade I or II hamstring strain.
  • Cessation of training due to injury.
  • No surgical intervention in the previous year (for initial assessment as potential participants).
  • Age over 18 years.
Show all 20Show fewer
  • Pain located between the lower ribs and the gluteal folds (top of the buttocks).
  • Pain occurred on fewer than half of the days over the preceding six months.
  • Pain intensity $\ge$ 6/10 on the Visual Analogue Scale (VAS).
  • Pain related to one or more of the following:
  • Lumbar facet joints
  • Sacroiliac joints
  • Lumbar intervertebral discs
  • Muscles, tendons, or ligaments of the lumbar and sacral region
  • Other bony structures of the lumbar spine
  • Discontinuation of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics:
  • 1 day prior to measurement
  • 48 hours after measurement
  • Episodes of low back pain (between the lower rib margin and the gluteal fold) for at least half of the days during the last 6 months.
  • Pain intensity $\ge$ 20% on the Visual Analogue Scale (VAS).

Who cannot join

  • History of injury to the same muscle (ipsilateral side) within the last 6 months.
  • Other injury to the posterior aspect of the thigh.
  • Other injuries or chronic pain in the trunk or lower limbs.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) in the 3 months prior to the injury.
  • Individuals with Acute Low Back Pain
  • Radiographic evidence of inflammatory disease affecting the spine.
Show all 23Show fewer
  • Spinal fracture.
  • Significant genetic structural abnormality of the spine.
  • Pregnancy.
  • Psychiatric disorders.
  • Receipt of systemic medication or treatment in the last 3 months.
  • Presence of neurological deficits (sensory, motor, or reflexes).
  • Receipt of TENS or TECAR therapy within the last year.
  • Individuals with Chronic Low Back Pain
  • Spinal stenosis.
  • Radiographic evidence of inflammatory disease affecting the spine.
  • Vertebral fracture.
  • Presence of spondylolisthesis or spondylolytic lesion (spondylolysis).
  • Significant genetic structural abnormality of the spine.
  • Daily, severe low back pain.
  • Pregnancy.
  • Use of medications that might influence heart rate or blood pressure.
  • Psychiatric disorders.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eleftherios Kellis, Ph.D. contact

+302310991053

ekellis@phed-sr.auth.gr

Anna Kellis, MSc contact

+302510240610

anna24kellis@google.com

Greece2 sites, 2 recruiting

  • Physiotherapy Clinic

    Kavala, 64100

    Anna Kelli, MSc, physiokelli@gmail.com

    Recruiting

  • Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki

    Serres, 62100

    Eleftherios Kellis, Ph.D., ekellis@phed-sr.auth.gr

    Recruiting

Other trials in Greece

About this study

Official title: Acute and Chronic Effects of High Frequency RF Electrical Current on Pain and Muscle Function in Individuals With Musculoskeletal Pain

The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. The participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (Acute effects) as well as 3 and 6 months after the intervention (chronic effects).

Read the detailed description

The purpose of this study is to examine the acute and chronic effects of high-frequency electrical current transfer (TECAR) on pain and functional movement in individuals with musculoskeletal injuries. The project is conducted in two phases to distinguish between immediate and long-term therapeutic outcomes. In the first phase, the acute effects of a single 20-minute TECAR session (Capacitive mode, 0.5 MHz, 40-60% intensity) are compared to transcutaneous electrical stimulation (TENS, asymmetric biphasic mode, 80Hz) and a control group in participants with acute hamstring strain or acute low back pain, defined as episodes occurring for less than half the days in the past six months with a visual analogue pain intensity > 6/10. Outcome measures are obtained at baseline, immediately post-intervention, and at 24 and 48 hours. In the chronic phase, participants with hamstring injuries or chronic low back pain receive 10 sessions (3 times per week) while outcome measurements are obtained before, immediately after, and at 3 and 6 months follow-up. Statistical analysis involves a Mixed-Model Analysis of Variance (ANOVA) to evaluate group-by-time interactions for outcomes including the Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and flexibility measures. For significant results, Tukey's post-hoc tests are utilized for pairwise comparisons. Additionally, non-parametric Kruskal-Wallis and Friedman tests are used to analyze percentage changes in clinical scores. Treatment effect sizes are quantified using partial eta squared with the level of significance set at p < 0.05.

Being tested
Radiofrequency Energy Transfer, Transcutaneous Nerve Stimulation
Keywords
Sport injuries, TECAR therapy, Low back pain, Muscle injury
Medical subject headings
Wounds and Injuries, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency Energy TransferDevice

    Also called TECAR

    Radiofrequency Electrical Currents (TECAR) will be delivered using a winback system (Winback, Villeneuve-Loubet, France) propagating radiofrequency waves of 448 kHz using metallic electrodes via a coupling medium. Radiofrequencies will be used in the capacitive mode , which aims to treat superficial /soft tissues in the area. The "active" plate will be applied sequentially on the skin in the injured or painful region. The base plate will be located to the other side of the injured body region (for back thigh muscle injuries, for example, the base plate will be located on the frontal thigh area, to close the current circuit. Therapy will be applied for 20 minutes, with a target intensity of 40% and a frequency of 0.5Mhz.

  • Transcutaneous Nerve StimulationDevice

    Also called TENS

    Transcutaneous nerve stimulation (TENS) will be delivered using a Chattanooga Intellect Advanced Combo system (Chattanooga, Hixson, TN 3 7343, USA). Two electrodes will be placed on the skin at a distance so that they cover the entire painful area. The TENS asymmetric biphasic mode (phase 300 ms, frequency 80Hz, continuous cycle) will be applied. The intensity will be adjusted between 0 and 110A, such that it is tolerable by the participant. The total application time will be 20 minutes or equal to that applied for the TECAR group.

Study groups in NCT05345015
Study groupRoleWhat they receive
TECAR therapyExperimentalParticipants in this arm receive high-frequency electrical current transfer (TECAR) using the Winback system at 0.5 MHz in capacitive mode with 40-60% intensity. In the acute phase, participants receive a single 20-minute session for acute hamstring strain or acute low back pain. In the chronic phase, participants receive 10 sessions (3 times per week) for hamstring injury or chronic low back pain.
Receives: Device: Radiofrequency Energy Transfer; Device: Transcutaneous Nerve Stimulation
TENS TherapyActive comparatorParticipants in this arm receive transcutaneous electrical nerve stimulation (TENS) using a Chattanooga system with an asymmetric biphasic mode at 80 Hz. In the acute phase, participants receive a single 20-minute session for acute hamstring strain or acute low back pain. In the chronic phase, participants receive 10 sessions (3 times per week) for hamstring injury or chronic low back pain.
Receives: Device: Radiofrequency Energy Transfer; Device: Transcutaneous Nerve Stimulation
Control groupNo interventionParticipants in this arm serve as the control group and do not receive any active electrophysical intervention during the assessment periods. For the acute phase, outcomes are measured over a 48-hour window. For the chronic phase, outcomes are measured at baseline and follow-up intervals to account for natural recovery and baseline variations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain Intensity

    Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain

    Measured: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6

  2. Change in sit and reach test measurement

    From supine position, with the feet in contact with a wooden box and the trunk flexed, participants attempt to reach with their hands as far as posible. Score is measured in cm. A higher measurement indicates higher flexibility

    Measured: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6

  3. Change in straight leg raising test

    From supine position, the tester raises one leg (with the knee flexed about 10-20 degrees) until discomfort is reported. The range of motion (in degrees) is stored.

    Measured: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: before, month 3, month 6

  4. Change in Oswestry index score

    A questionnaire which provides a score which reflects function in activities of daily living for those with acute or chronic back pain. It consists of 10 categories of questions, with a total sum of 50. Score is expressed as a percentage of 50, where 0% indicates no functional disability and pain. 100% indicates maximum functional disability and pain

    Measured: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6

  5. Change in prone flexibility test

    From the prone position, the tester flexes the knee of the participant. The maximum range of motion is stored in degrees

    Measured: CHRONIC PHASE STUDY: Before, month 3, month 6

Secondary outcomes (2)

  1. Functional Assessment Scale for Acute Hamstring Injuries (FASH)

    A questionnaire for the assessment of hamstring injury severity and its impact on function of injured individuals. The questionnaire consists of 10 items, each given a score from 0 to 10, where 10 represents a high level of physical ability and 0 represents complete disability. Items scores are then added, such that a lowest total score indicates more severe symptoms.

    Measured: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6

  2. Change in single leg balance test center of pressure

    Displacement of center of pressure during a 30s single-leg standing test on a pressure platform. A greater center of pressure displacement indicates less postural stability.

    Measured: CHRONIC EFFECTS STUDY: Before, month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start1 Sep 2022
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Parallel groups
Model description
Participants are assigned to an electrical energy transfer (TECAR), a Transcutaneous Electrical Stimulation (TENS) or a control (CON) group in parallel for the duration of the study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05345015
Sponsor's protocol ID
TECAR22#1
Status last verified
Apr 2026
First submitted
9 Apr 2022
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in this study may be made available upon reasonable request. However, under no circumstances will identifiable personal information, medical records, or any data that could compromise participant confidentiality be provided. All shared data will be strictly anonymized and restricted to numerical outcome measurements to ensure full compliance with privacy regulations and the study's ethics protocol

Publications

  • Paolucci T, Pezzi L, Centra AM, Giannandrea N, Bellomo RG, Saggini R. Electromagnetic Field Therapy: A Rehabilitative Perspective in the Management of Musculoskeletal Pain - A Systematic Review. J Pain Res. 2020 Jun 12;13:1385-1400. doi: 10.2147/JPR.S231778. eCollection 2020.

    PubMed 32606905

  • Paolucci T, Pezzi L, Centra MA, Porreca A, Barbato C, Bellomo RG, Saggini R. Effects of capacitive and resistive electric transfer therapy in patients with painful shoulder impingement syndrome: a comparative study. J Int Med Res. 2020 Feb;48(2):300060519883090. doi: 10.1177/0300060519883090. Epub 2019 Nov 4.

    PubMed 31680597

  • Takahashi K, Suyama T, Onodera M, Hirabayashi S, Tsuzuki N, Zhong-Shi L. Clinical Effects of Capacitive Electric Transfer Hyperthermia Therapy for Lumbago. J Phys Ther Sci. 1999;11:45-51. doi:10.1589/jpts.11.45.

  • Hernandez-Bule ML, Paino CL, Trillo MA, Ubeda A. Electric stimulation at 448 kHz promotes proliferation of human mesenchymal stem cells. Cell Physiol Biochem. 2014;34(5):1741-55. doi: 10.1159/000366375. Epub 2014 Nov 12.

    PubMed 25427571

  • Kumaran B, Watson T. Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults. Int J Hyperthermia. 2015;31(8):883-95. doi: 10.3109/02656736.2015.1092172. Epub 2015 Nov 2.

    PubMed 26524223

  • Bretelle F, Fabre C, Golka M, Pauly V, Roth B, Bechadergue V, Blanc J. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study. PLoS One. 2020 Apr 27;15(4):e0231869. doi: 10.1371/journal.pone.0231869. eCollection 2020.

    PubMed 32339169

  • Fousekis K, Chrysanthopoulos G, Tsekoura M, Mandalidis D, Mylonas K, Angelopoulos P, Koumoundourou D, Billis V, Tsepis E. Posterior thigh thermal skin adaptations to radiofrequency treatment at 448 kHz applied with or without Indiba(R) fascia treatment tools. J Phys Ther Sci. 2020 Apr;32(4):292-296. doi: 10.1589/jpts.32.292. Epub 2020 Apr 2.

    PubMed 32273653

  • Tashiro Y, Hasegawa S, Yokota Y, Nishiguchi S, Fukutani N, Shirooka H, Tasaka S, Matsushita T, Matsubara K, Nakayama Y, Sonoda T, Tsuboyama T, Aoyama T. Effect of Capacitive and Resistive electric transfer on haemoglobin saturation and tissue temperature. Int J Hyperthermia. 2017 Sep;33(6):696-702. doi: 10.1080/02656736.2017.1289252. Epub 2017 Feb 19.

    PubMed 28139939

  • Yokota Y, Sonoda T, Tashiro Y, Suzuki Y, Kajiwara Y, Zeidan H, Nakayama Y, Kawagoe M, Shimoura K, Tatsumi M, Nakai K, Nishida Y, Bito T, Yoshimi S, Aoyama T. Effect of Capacitive and Resistive electric transfer on changes in muscle flexibility and lumbopelvic alignment after fatiguing exercise. J Phys Ther Sci. 2018 May;30(5):719-725. doi: 10.1589/jpts.30.719. Epub 2018 May 8.

    PubMed 29765189

  • Tashiro Y, Suzuki Y, Nakayama Y, Sonoda T, Yokota Y, Kawagoe M, Tsuboyama T, Aoyama T. The effect of Capacitive and Resistive electric transfer on non-specific chronic low back pain. Electromagn Biol Med. 2020 Oct 1;39(4):437-444. doi: 10.1080/15368378.2020.1830795. Epub 2020 Oct 6.

    PubMed 33021115

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency Energy Transfer and Transcutaneous Nerve Stimulation in people with Transcutaneous Electric Nerve Stimulation and Chronic Low-back Pain, run by Aristotle University Of Thessaloniki at 2 sites in Greece.

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 20 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Eleftherios Kellis, Ph.D. (+302310991053, ekellis@phed-sr.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain Intensity (time frame: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05345015, which also lists 10 linked publications.

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 26 Jun 2026.

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