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Recruiting Not applicable NCT05345015

High Frequency RF Current Effects on Muscle Pain and Function

No applicable phase (e.g. observational)
Conditions: Transcutaneous Electric Nerve Stimulation Chronic Low-back Pain Hamstring Injury Muscle; Injury, Quadriceps (Thigh) Physical Therapy Calf Muscle Pulled Acute Low Back Pain

Sponsor: Aristotle University Of Thessaloniki

trial.available_in: БГ
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).
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.
Who can participate
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.
Interventions
Radiofrequency Energy Transfer
DEVICE
Transcutaneous Nerve Stimulation
DEVICE
Locations 2
Greece (2)
Physiotherapy Clinic
Kavala
Anna Kelli, MSc
Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki
Serres
Eleftherios Kellis, Ph.D.
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
30.04.2022
Completion date
31.12.2029
Registry ID
NCT05345015
Source
clinicaltrials.gov
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