Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve

NCT ID: NCT06894537

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2025-04-01

Brief Summary

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).

Conditions

Health Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental (percutaneous echo-guided electrical nerve stimulation)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Control (placebo) group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Rubén Cuesta-Barriuso, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Católica San Antonio de Murcia

Murcia, Principality of Asturias, Spain

Countries

Spain

Other Identifiers

ECO-est

Identifier Type: -

Identifier Source: org_study_id