Acute Low Back Pain, Calf Muscle Pulled, Chronic Low-back Pain, Hamstring Injury, Muscle; Injury, Quadriceps (Thigh), Physical Therapy, Transcutaneous Electric Nerve Stimulation
Conditions
Keywords
Sport injuries, TECAR therapy, Low back pain, Muscle injury
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).
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
DEVICERadiofrequency 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 (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.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain Intensity | ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6 | Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain |
| Change in sit and reach test measurement | ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6 | 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 |
| Change in straight leg raising test | ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: before, month 3, month 6 | 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. |
| Change in Oswestry index score | ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6 | 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 |
| Change in prone flexibility test | CHRONIC PHASE STUDY: Before, month 3, month 6 | From the prone position, the tester flexes the knee of the participant. The maximum range of motion is stored in degrees |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Change in single leg balance test center of pressure | CHRONIC EFFECTS STUDY: Before, month 6 | 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. |
Countries
Greece
Contacts
CONTACTEleftherios Kellis, Ph.D.
CONTACTAnna Kellis, MSc
PRINCIPAL_INVESTIGATOREleftherios Kellis, Ph.D.
Professor
STUDY_DIRECTORThomas Apostolou, M.D.
International Hellenic University
PRINCIPAL_INVESTIGATORParis Iakovidis, Ph.D.
International Hellenic University
Outcome results
None listed