High Frequency RF Current Effects on Muscle Pain and Function

Aristotle University Of Thessaloniki

Status: Enrolling

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

Treatments: Device: Radiofrequency Energy Transfer; Device: Transcutaneous Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05345015

TECAR22#1

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 4/10
• Pain incidents for for less than half the days in the past six months

Exclusion Criteria:

• radiographic evidence of inflammatory disease affecting the spine
• fracture
• important genetic structure abnormality in the spine
• 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
• No neurologic deficits (sensory, motor, or reflexes)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Acute effects

Experimental group

Description:

The experimental group will receive one single session of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The TENS group will receive one 20-minute session of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f\< 50Hz). The control (CON) group will not receive any intervention. Outcome measures will be measured prior to, immediately after, 24 and 48 hours after.

Treatment:

Device: Transcutaneous Nerve Stimulation

Device: Radiofrequency Energy Transfer

Chronic effects

Experimental group

Description:

The experimental group will receive 10 sessions of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The TENS group will receive 10 20-minute sessions of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f\< 50Hz). The control (CON) group will not receive any intervention. Outcome measures will be measured prior to, immediately after, 3 and 6 months after.

Treatment:

Device: Transcutaneous Nerve Stimulation

Device: Radiofrequency Energy Transfer