High Frequency RF Current Effects on Muscle Pain and Function

Not Applicable

Recruiting

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

• Registration Number: NCT05345015
• Lead Sponsor: Aristotle University Of Thessaloniki

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 (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.

Study Timeline

• Study First Submitted: 2022-04-09
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-04-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-05-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute effects	Radiofrequency Energy Transfer	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.
Acute effects	Transcutaneous Nerve Stimulation	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.
Chronic effects	Radiofrequency Energy Transfer	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.
Chronic effects	Transcutaneous Nerve Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in pain Intensity	Day before, day 0, day 1, day 2, 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	Day before, day 0, day 1, day 2, 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	Day before, day 0, day 1, day 2, 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 prone flexibility test	Day before, day 0, day 1, day 2, 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
Change in Oswestry index score	Day before, day 0, day 1, day 2, 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

Secondary Outcome Measures

Name	Time	Method
Change in single leg balance test center of pressure	Day before, day 0, day 1, day 2, month 3, 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.
Functional Assessment Scale for Acute Hamstring Injuries (FASH)	Day before, day 0, day 1, day 2, 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.

Trial Locations

Locations (2)

Physiotherapy Clinic; 🇬🇷 Kavala, Greece

Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki; 🇬🇷 Serres, Greece