High Frequency RF Current Effects on Muscle Pain and Function

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345015
• Other study ID #: TECAR22#1
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Aristotle University Of Thessaloniki
• Contact: Eleftherios Kellis, Ph.D.
• Phone: +302310991053
• Email: ekellis[@]phed-sr.auth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Description:

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. Participants referred for muscle strain injury (hamstring, quadriceps, gastrocnemius) or chronic low back pain will be randomly allocated into one of the three groups: an experimental group (muscle injuries), experimental group (low back pain) and a control group. The project is divided in two phases. In the first phase, the acute effects of TECAR therapy will be examined. Outcome measures will be obtained prior to, after, 24 and 48 hours following a single intervention session. The intervention consists of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%) or a typical transcutaneous electrical stimulation (TENS, asymmetric biphasic mode, rectangular pulse, f = 80Hz) protocol. In the chronic stage, participants will receive 10 sessions (3 times a week) receiving either protocol while outcome measurements will be obtained before, immediately, 3 and 6 months after the intervention. Analysis of variance designs will be used to compare differences in each outcome between groups at different measurement sessions. The alpha level is set to p <0.05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Muscle injury group

Inclusion Criteria:

• Acute hamstring or quadriceps or calf strain injury

• Age above 18 years

Exclusion Criteria:

• Other injury or musculoskeletal condition

• Any observed organ dysfunctions

• Receipt of medication or treatment for the past 3 months

Low back pain group

Inclusion criteria

• 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 2/10

Exclusion Criteria:

• spinal stenosis

• radiographic evidence of inflammatory disease affecting the spine

• fracture

• spondylolysis or spondylolisthesis

• important genetic structure abnormality in the spine

• daily intensive low back pain

• 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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Hamstring Injury
• Low Back Pain
• Physical Therapy
• Transcutaneous Electric Nerve Stimulation
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Greece	Physiotherapy Clinic	Kavala
Greece	Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki	Serres

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain Intensity	Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain	Day before, day 0, day 1, day 2, month 3, month 6
Primary	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	Day before, day 0, day 1, day 2, month 3, month 6
Primary	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.	Day before, day 0, day 1, day 2, month 3, month 6
Primary	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	Day before, day 0, day 1, day 2, month 3, month 6
Primary	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	Day before, day 0, day 1, day 2, month 3, month 6
Secondary	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.	Day before, day 0, day 1, day 2, month 3, month 6