Effects of high frequency electrical current 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

This study is testing if a new type of electrical therapy called TECAR can help people with muscle pain and movement problems feel better compared to a standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Aristotle University Of Thessaloniki (other)
• Locations: 2 sites (Kavala and 1 other locations)
• Trial ID: NCT05345015 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of high frequency electrical current transfer, known as TECAR therapy, on pain and functional movement in individuals with musculoskeletal injuries or chronic low back pain. Participants will be randomly assigned to either an experimental group receiving TECAR therapy or a control group receiving traditional transcutaneous electrical stimulation (TENS). The study will assess both acute effects immediately after treatment and chronic effects over a period of three to six months through various outcome measures. The goal is to determine the efficacy of TECAR therapy in improving pain and function in affected individuals.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with acute muscle strain injuries or chronic low back pain.

Not a fit: Patients with other musculoskeletal conditions, significant spinal abnormalities, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide significant pain relief and improved function for patients with muscle injuries and chronic low back pain.

How similar studies have performed: While TECAR therapy is a relatively novel approach, similar studies using electrical stimulation techniques have shown promising results in pain management.

Eligibility criteria

Individuals with Muscle Injury

Inclusion Criteria:

* 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.
* No surgical intervention in the previous year (for initial assessment as potential participants).

Exclusion Criteria:

* 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.

Individuals with Acute Low Back Pain

Inclusion Criteria:

* Age over 18 years.
* Pain located between the lower ribs and the gluteal folds (top of the buttocks).
* Pain occurred on fewer than half of the days over the preceding six months.
* Pain intensity $\\ge$ 6/10 on the Visual Analogue Scale (VAS).
* Pain related to one or more of the following:

  * Lumbar facet joints
  * Sacroiliac joints
  * Lumbar intervertebral discs
  * Muscles, tendons, or ligaments of the lumbar and sacral region
  * Other bony structures of the lumbar spine
* Discontinuation of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics:

  * 1 day prior to measurement
  * 48 hours after measurement

Exclusion Criteria:

* Radiographic evidence of inflammatory disease affecting the spine.
* Spinal fracture.
* Significant genetic structural abnormality of the spine.
* Pregnancy.
* Psychiatric disorders.
* Receipt of systemic medication or treatment in the last 3 months.
* Presence of neurological deficits (sensory, motor, or reflexes).
* Receipt of TENS or TECAR therapy within the last year.

Individuals with Chronic Low Back Pain

Inclusion Criteria:

* Episodes of low back pain (between the lower rib margin and the gluteal fold) for at least half of the days during the last 6 months.
* Pain intensity $\\ge$ 20% on the Visual Analogue Scale (VAS).

Exclusion Criteria:

* Spinal stenosis.
* Radiographic evidence of inflammatory disease affecting the spine.
* Vertebral fracture.
* Presence of spondylolisthesis or spondylolytic lesion (spondylolysis).
* Significant genetic structural abnormality of the spine.
* Daily, severe low back pain.
* Pregnancy.
* Use of medications that might influence heart rate or blood pressure.
* Psychiatric disorders.

Where this trial is running

Kavala and 1 other locations

• Physiotherapy Clinic — Kavala, Greece (RECRUITING)
• Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki — Serres, Greece (RECRUITING)

Study contacts

• Principal investigator: Eleftherios Kellis, Ph.D. — Professor
• Study coordinator: Eleftherios Kellis, Ph.D.

Conditions: Transcutaneous Electric Nerve Stimulation, Chronic Low-back Pain, Hamstring Injury, Muscle, Injury, Quadriceps, Physical Therapy, Calf Muscle Pulled, Acute Low Back Pain