Health SubjectsNCT06894537
Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve
A study testing Experimental (percutaneous echo-guided electrical nerve stimulation) in people with Health Subjects, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Subjects
- What is being tested?
- Experimental (percutaneous echo-guided electrical nerve stimulation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 18 Mar 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons aged 18 and 24.
- Of both sexes.
- Who practice sport at least twice a week.
- Who sign the informed consent document.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Católica San Antonio de Murcia
Murcia, Principality of Asturias, 33006
About this study
Official 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.
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
- Being tested
- Experimental (percutaneous echo-guided electrical nerve stimulation), Control (placebo) group
- Keywords
- Percutaneous electrical nerve stimulation, Femoral nerve, Vertical jump, Skin temperature, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, within the first seven days after warming, treatment and after 1 and 24 hours follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start18 Mar 2025
- Primary completion25 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894537
- Sponsor's protocol ID
- ECO-est
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06894537
- Acronym / sponsor ID
- ECO-est
- Conditions
- Health Subjects
- Keywords
- Percutaneous electrical nerve stimulation, Femoral nerve, Vertical jump, Skin temperature, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental (percutaneous echo-guided electrical nerve stimulation)The intervention of the experimental group will consist of an intervention by performing percutaneous echo-guided electrical nerve stimulation of the femoral nerve. |
| Control | Active comparator | Other: Control (placebo) groupThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Persons aged 18 and 24.
- Of both sexes.
- Who practice sport at least twice a week.
- Who sign the informed consent document.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental group |
| Control (placebo) groupFor 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. | Other | Control |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (percutaneous echo-guided electrical nerve stimulation) in people with Health Subjects, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.