NCT05345015

High Frequency RF Current Effects on Muscle Pain and Function

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Radiofrequency Energy Transfer	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.
DEVICE	Transcutaneous Nerve Stimulation	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.

Timeline

• Start date: 2022-04-30
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2022-04-25
• Last updated: 2025-01-29

Locations

2 sites across 1 country: Greece