Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve

NCT06894537 | Completed

• 1 other identifier: ECO-est
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Percutaneous electrical nerve stimulation; Femoral nerve; Vertical jump; Skin temperature; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

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

Interventions

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.

Experimental group

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.

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 25, 2025
• Study Start: March 18, 2025
• Primary Completion: March 25, 2025
• Study Completion: April 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)