Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve

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.

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).

Study Overview

• Status: Completed
• Conditions: Health Subjects
• Intervention / Treatment: Other: Experimental (percutaneous echo-guided electrical nerve stimulation); Other: Control (placebo) group

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Asturias
    • Murcia, Asturias, Spain, 33006
      • Universidad Católica San Antonio de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The intervention of the experimental group will consist of an intervention by performing percutaneous echo-guided electrical nerve stimulation of the femoral nerve.	Other: Experimental (percutaneous echo-guided electrical nerve stimulation); 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.
Active Comparator: Control; The intervention of the control group will be carried out in the same way as in the experimental intervention, but without increasing the intensity of the current.	Other: Control (placebo) group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline jump height after warming, treatment and at 1 and 24 hours	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.	Baseline, within the first seven days after warming, treatment and after 1 and 24 hours follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline muscle power after warming, treatment and at 1 and 24 hours	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.	Baseline, within the first seven days after warming, treatment and after 1 and 24 hours follow-up visit

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Physiotherapy; Skin temperature; Vertical jump; Percutaneous electrical nerve stimulation; Femoral nerve
• Other Study ID Numbers: ECO-est

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No