High Frequency RF Current Effects on Muscle Pain and Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAristotle University Of Thessaloniki

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: TECAR therapyExperimental treatment 2 interventions
Group B: TENS TherapyActive comparator 2 interventions
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in pain Intensity

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

Time frame
ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6
2

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

Time frame
ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6
3

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.

Time frame
ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: before, month 3, month 6
4

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

Time frame
ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6

Secondary outcomes

1

Functional Assessment Scale for Acute Hamstring Injuries (FASH)

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.

Time frame
ACUTE EFFECTS STUDY: Day before, day 0, day 1, day 2 CHRONIC EFFECTS STUDY: Before, month 3, month 6
2

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.

Time frame
CHRONIC EFFECTS STUDY: Before, month 6

Other outcomes

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