New treatment option for Transcutaneous Electric Nerve Stimulation
Official title High Frequency RF Current Effects on Muscle Pain and Function
ClinicalTrials.gov ID: NCT05345015
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Individuals with Muscle Injury
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
- Individuals with Muscle Injury
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kavala, Greece
- Serres, Greece
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kavala, Greece; Serres, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.