High Frequency RF Current Effects on Muscle Pain and Function

NCT05345015 | Recruiting

• 1 other identifier: TECAR22#1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Transcutaneous Electric Nerve Stimulation; Chronic Low-back Pain; Hamstring Injury; Muscle; Injury, Quadriceps (Thigh); Physical Therapy; Calf Muscle Pulled; Acute Low Back Pain

Keywords

Sport injuries; TECAR therapy; Low back pain; Muscle injury

Outcome Measures

Primary Outcomes (5)

• Change in pain Intensity

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

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

• 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

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

• 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.

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

• 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

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

• 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

  CHRONIC PHASE STUDY: Before, month 3, month 6

Secondary Outcomes (2)

• Functional Assessment Scale for Acute Hamstring Injuries (FASH)

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

• Change in single leg balance test center of pressure

  CHRONIC EFFECTS STUDY: Before, month 6

Study Arms (3)

TECAR therapy

EXPERIMENTAL

Participants 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.

Device: Radiofrequency Energy Transfer; Device: Transcutaneous Nerve Stimulation

TENS Therapy

ACTIVE COMPARATOR

Participants 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.

Device: Radiofrequency Energy Transfer; Device: Transcutaneous Nerve Stimulation

Control group

NO INTERVENTION

Participants 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.

Interventions

Radiofrequency Energy Transfer DEVICE

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.

Also known as: TECAR

TECAR therapy; TENS Therapy

Transcutaneous Nerve Stimulation DEVICE

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.

Also known as: TENS

TECAR therapy; TENS Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Age over 18 years.
• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (2)

Physiotherapy Clinic

Kavala, 64100, Greece

RECRUITING

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

Serres, 62100, Greece

RECRUITING

Related Publications (10)

• 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.

  PMID: 32606905 BACKGROUND

• 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.

  PMID: 31680597 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25427571 BACKGROUND

• 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.

  PMID: 26524223 BACKGROUND

• 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.

  PMID: 32339169 BACKGROUND

• 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.

  PMID: 32273653 BACKGROUND

• 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.

  PMID: 28139939 BACKGROUND

• 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.

  PMID: 29765189 BACKGROUND

• 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.

  PMID: 33021115 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Eleftherios Kellis, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

• Thomas Apostolou, M.D.

  International Hellenic University

  STUDY DIRECTOR

• Paris Iakovidis, Ph.D.

  International Hellenic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleftherios Kellis, Ph.D.

CONTACT

+302310991053; ekellis@phed-sr.auth.gr

Anna Kellis, MSc

CONTACT

+302510240610; anna24kellis@google.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Due to the distinct physical sensations associated with the different interventions-specifically the thermal sensation of TECAR therapy and the electrical paresthesia of TENS-masking of participants and care providers is not feasible. To minimize bias, a single-masked design is employed where the outcomes assessor is blinded to group allocation. Outcome measures are recorded and assigned unique alphanumeric codes by administrative staff not involved in data collection. This ensures that the assessor remains blinded to the intervention received by each participant during the evaluation and data entry processes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 25, 2022
• Study Start: April 30, 2022
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 24 months after the publication of results.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal. Requests must be directed to the corresponding author and are subject to approval based on the study's ethical and privacy guidelines.

Locations

GR (2)