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Completed

NCT Number: NCT06894537

Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve

Introduction. Variables such as pain and strength can be modified in the short and medium term by the application of currents. The percutaneous form of percutaneous needle-guided acupuncture can eliminate the impedance of the surrounding tissues that limit the optimal diffusion of the current to the target tissue. It is necessary to objectify the metabolic response of this technique and its effects in terms of strength and metabolic response.

Objective. To evaluate the safety and efficacy, in acute and subacute phases, of percutaneous electrical nerve stimulation in healthy subjects.

Method. Single-blind randomised clinical study. Thirty-two subjects will be recruited and randomised to the experimental and control groups. The intervention in the experimental group will consist of a percutaneous percutaneous electrical nerve stimulation of the femoral nerve, while in the control group the same intervention will be performed without increasing the intensity of the current. The primary variable will be vertical jump height (My Jump® iOS app) and the secondary variable will be skin temperature (Hikmicro M60 model Hangzhou).

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Key information

Conditions

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio de Murcia

Murcia, Principality of Asturias, 33006, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons aged 18 and 24.
  • Of both sexes.
  • Who practice sport at least twice a week.
  • Who sign the informed consent document.

Exclusion criteria

  • Medical diagnosis of chronic systemic diseases or diseases that may interfere with thermographic imaging (rheumatoid arthritis, fibromyalgia, deep vein thrombosis, etc.).
  • Having undergone lower limb surgery in the 24 months prior to the study.
  • Intake of drugs that may influence the thermographic response (antipyretics, non-steroidal anti-inflammatory drugs, topical solutions on the area to be studied, etc.).
  • People with nickel allergy or belonephobia (needle phobia).

Treatment and study plan

Experimental (percutaneous echo-guided electrical nerve stimulation)

Other

The protocol applied in this study will consist of: 10 stimulations of 10 seconds at 10Hz with a rest of 10 seconds between one stimulation and the next one. The intensity of the current (mA) will be adapted to each of the subjects until the greatest possible muscle contraction is achieved without reaching the painful threshold.

Control (placebo) group

Other

For the subjects in the control group, the same process shall be carried out without increasing the intensity of the current. It shall be explained to the subjects that the current will reach a non-perceptible stimulus.

Primary outcomes

  1. Change from baseline jump height after warming, treatment and at 1 and 24 hours

    Time frame: Baseline, within the first seven days after warming, treatment and after 1 and 24 hours follow-up visit

    Using the My Jump® application (iOS app), the jump height is evaluated. This tool measures the time in the air (in milliseconds), indirectly assessing the height of the jump (in centimetres). This tool has shown a high reliability in the evaluation of counter movement jump. The unit of measurement is centimetres (cm), where the higher the centimetres, the higher the jump height.

Secondary outcomes

  1. Change from baseline muscle power after warming, treatment and at 1 and 24 hours

    Time frame: Baseline, within the first seven days after warming, treatment and after 1 and 24 hours follow-up visit

    The metabolic response will be measured with a thermography device (Hikmicro M60 model Hangzhou camera). This complementary imaging technique analyses infrared radiation emitted by object surfaces (skin) and reflects the state of molecular agitation, providing objective information on the metabolic state of the underlying structures. The assessment shall be performed according to the consensus document on control variables in thermographic assessment.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Efficacy of Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve on Explosive Strength and Metabolic Response in Healthy Subjects. A Randomised Clinical Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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