High Frequency RF Current Effects on Muscle Pain and Function

Official title

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

Overview

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).

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.

Interventions

• 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 (f
• Device 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

Primary outcome measures

• 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]
• Change in sit and reach test measurement [Time frame: 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 [Time frame: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: before, month 3, month 6]
• Change in Oswestry index score [Time frame: ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6]
• Change in prone flexibility test [Time frame: CHRONIC PHASE STUDY: Before, month 3, month 6]

Secondary outcome measures (2)

• Functional Assessment Scale for Acute Hamstring Injuries (FASH) [Time frame: 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 [Time frame: CHRONIC EFFECTS STUDY: Before, month 6]

Eligibility criteria

Individuals with Muscle Injury

Inclusion criteria

• 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).

Exclusion criteria

• 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

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:

• 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

Exclusion criteria

• Radiographic evidence of inflammatory disease affecting the spine.
• 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

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Greece · 2 centers

• Physiotherapy Clinic — Kavala
• Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotl — Serres

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28139939

Identifiers

NCT: NCT05345015 · TECAR22#1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗