High Frequency RF Current Effects on Muscle Pain and Function

Study Overview
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Brief Summary
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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
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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. Participants referred for muscle strain injury (hamstring, quadriceps, gastrocnemius) or chronic low back pain will be randomly allocated into one of the three groups: an experimental group (muscle injuries), experimental group (low back pain) and a control group. The project is divided in two phases. In the first phase, the acute effects of TECAR therapy will be examined. Outcome measures will be obtained prior to, after, 24 and 48 hours following a single intervention session. The intervention consists of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%) or a typical transcutaneous electrical stimulation (TENS, asymmetric biphasic mode, rectangular pulse, f = 80Hz) protocol. In the chronic stage, participants will receive 10 sessions (3 times a week) receiving either protocol while outcome measurements will be obtained before, immediately, 3 and 6 months after the intervention. Analysis of variance designs will be used to compare differences in each outcome between groups at different measurement sessions. The alpha level is set to p <0.05.

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

Conditions
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Transcutaneous Electric Nerve Stimulation, Chronic Low-back Pain, Hamstring Injury, Muscle; Injury, Quadriceps (Thigh), Physical Therapy, Calf Muscle Pulled

Intervention / Treatment
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* Device: Radiofrequency Energy Transfer
* Device: Transcutaneous Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Muscle injury group Inclusion Criteria: Acute hamstring or quadriceps or calf strain injury Age above 18 years Exclusion Criteria: Other injury or musculoskeletal condition Any observed organ dysfunctions Receipt of medication or treatment for the past 3 months Low back pain group Inclusion criteria Pain between bottom of ribs and buttock creases Incidents for at least half the days in the past six months Visual analogue pain score equal or greater than 2/10 Exclusion Criteria: spinal stenosis radiographic evidence of inflammatory disease affecting the spine fracture spondylolysis or spondylolisthesis important genetic structure abnormality in the spine daily intensive low back pain pregnancy use of medication that might influence heart rate and/or blood pressure psychiatric disorders receipt of medication or treatment for the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to either a electrical energy transfer (TECAR) or a Transcutaneous Electrical Stimulation (TENS) group in parallel for the duration of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute effects<br>The experimental group will receive one single session of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The control group will receive one 20-minute session of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f< 50Hz). Outcome measures will be measured prior to, immediately after, 24 and 48 hours after. | Device: Radiofrequency Energy Transfer<br>* 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.<br>* Other names: TECAR;Device: Transcutaneous Nerve Stimulation<br>* 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.<br>* Other names: TENS;|
| Experimental: Chronic effects<br>The experimental group will receive 10 sessions of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The control group will receive 10 20-minute sessions of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f< 50Hz). Outcome measures will be measured prior to, immediately after, 3 and 6 months after. | Device: Radiofrequency Energy Transfer<br>* 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.<br>* Other names: TECAR;Device: Transcutaneous Nerve Stimulation<br>* 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.<br>* Other names: TENS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain Intensity | Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain | Day before, day 0, day 1, day 2, month 3, month 6 | 
| 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 | Day before, day 0, day 1, day 2, month 3, month 6 | 
| 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. | Day before, day 0, day 1, day 2, month 3, month 6 | 
| Change in prone flexibility test | From the prone position, the tester flexes the knee of the participant. The maximum range of motion is stored in degrees | Day before, day 0, day 1, day 2, month 3, month 6 | 
| 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 | Day before, day 0, day 1, day 2, month 3, month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day before, day 0, day 1, day 2, month 3, month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sport injuries, TECAR therapy, Low back pain, Muscle injury