Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Individuals with Muscle Injury
Inclusion Criteria:
Exclusion Criteria:
Individuals with Acute Low Back Pain
Inclusion Criteria:
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:
Discontinuation of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics:
Exclusion Criteria:
Individuals with Chronic Low Back Pain
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleftherios Kellis, Ph.D. | Contact | +302310991053 | ekellis@phed-sr.auth.gr | |
| Anna Kellis, MSc | Contact | +302510240610 | anna24kellis@google.com |
| Name | Affiliation | Role |
|---|---|---|
| Eleftherios Kellis, Ph.D. | Professor | Principal Investigator |
| Thomas Apostolou, M.D. | International Hellenic University | Study Director |
| Paris Iakovidis, Ph.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiotherapy Clinic | Recruiting | Kavala | 64100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32606905 | Background | 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. | |
| 31680597 | 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. |
Not provided
Not provided
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
Beginning 6 months and ending 24 months after the publication of results.
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.
Not provided
Not provided
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
Not provided
Not provided
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.
|
|
| 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. |
|
|
| 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 | 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. | CHRONIC EFFECTS STUDY: Before, month 6 |
| International Hellenic University |
| Principal Investigator |
| Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki | Recruiting | Serres | 62100 | Greece |
|
| 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. |
| 25427571 | 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. |
| 26524223 | 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. |
| 32339169 | 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. |
| 32273653 | 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. |
| 28139939 | 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. |
| 29765189 | 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. |
| 33021115 | 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. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided