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NCT Number: NCT05345015

High Frequency RF Current Effects on Muscle Pain and Function

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy Clinic, Kavala, Greece

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About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: TECAR

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.

Other names: TENS

Primary outcomes

  1. 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

    Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain

  2. 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

    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

  3. 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

    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.

  4. 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

    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

  5. Change in prone flexibility test

    Time frame: 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 outcomes

  1. 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

    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.

  2. Change in single leg balance test center of pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Kellis, MSc

CONTACT

[email protected]

+302510240610

Eleftherios Kellis, Ph.D.

CONTACT

[email protected]

+302310991053

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Apr 25, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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