High Frequency RF Current Effects on Muscle Pain and Function
NCT ID: NCT05345015
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2022-04-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acute effects
The experimental group will receive one single session of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The TENS group will receive one 20-minute session of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f\< 50Hz). The control (CON) group will not receive any intervention. Outcome measures will be measured prior to, immediately after, 24 and 48 hours after.
Radiofrequency Energy Transfer
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 Stimulation
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.
Chronic effects
The experimental group will receive 10 sessions of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The TENS group will receive 10 20-minute sessions of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f\< 50Hz). The control (CON) group will not receive any intervention. Outcome measures will be measured prior to, immediately after, 3 and 6 months after.
Radiofrequency Energy Transfer
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 Stimulation
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.
Interventions
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Radiofrequency Energy Transfer
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 Stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age above 18 years
* Pain between bottom of ribs and buttock creases
* Incidents for at least half the days in the past six months
* Visual analogue pain score equal or greater than 4/10
* Pain incidents for for less than half the days in the past six months
Exclusion Criteria
* Any observed organ dysfunctions
* Receipt of medication or treatment for the past 3 months
Low back pain group
* radiographic evidence of inflammatory disease affecting the spine
* fracture
* important genetic structure abnormality in the spine
* pregnancy
* use of medication that might influence heart rate and/or blood pressure
* psychiatric disorders
* receipt of medication or treatment for the past 3 months
* No neurologic deficits (sensory, motor, or reflexes)
18 Years
65 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Eleftherios Kellis
Professor
Principal Investigators
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Eleftherios Kellis, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Professor
Thomas Apostolou, M.D.
Role: STUDY_DIRECTOR
International Hellenic University
Paris Iakovidis, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
International Hellenic University
Locations
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Physiotherapy Clinic
Kavala, , Greece
Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki
Serres, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TECAR22#1
Identifier Type: -
Identifier Source: org_study_id
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