Comparative Study of Two Ultrasound-guided Percutaneous Neuromodulation Protocols on Maximal Handgrip Strength.

November 27, 2025 updated by: Dr. Pablo Herrero Gallego, Universidad de Zaragoza

Comparative Study of Two Ultrasound-guided Percutaneous Neuromodulation Protocols on Maximal Handgrip Strength: a Randomized Clinical Trial.

Purpose of the Study:

This study aims to compare the effects of two different ultrasound-guided percutaneous neuromodulation (PNM) protocols targeting the median nerve on maximal handgrip strength in healthy individuals. The study seeks to enhance scientific understanding of the clinical applications of PNM in improving neuromuscular performance and functional capacity.

Benefits of the Study:

Contribute to the evidence base supporting the use of PNM in physiotherapy and rehabilitation.

Inform future therapeutic protocols aiming to optimize muscle strength and functional recovery.

Provide participants with access to a professional evaluation of physical performance and exposure to advanced rehabilitative techniques in a safe and monitored environment.

Interventions:

Participants will undergo a single session of ultrasound-guided PNM to the median nerve using one of two protocols:

Protocol 1 (100 Hz): 5 cycles of 5 seconds stimulation (350 µs pulse width), followed by 55 seconds rest.

Protocol 2 (10 Hz): 10 cycles of 10 seconds stimulation (250 µs pulse width), followed by 10 seconds rest.

In both protocols, stimulation intensity will be set to the maximum tolerable level that elicits a strong but non-painful muscular contraction. Total treatment duration will be approximately 10 minutes.

Measurements:

Primary Outcome: Maximal handgrip strength measured using a digital dynamometer before and after the intervention.

Secondary Outcomes: Perceived pain during the intervention, assessed with the Numerical Pain Rating Scale (0-10). Sociodemographic data (age, sex, weight, height, BMI).

Conclusion:

This clinical trial will provide valuable insights into the comparative effectiveness of two PNM protocols for improving muscular performance. By identifying the most effective parameters for PNM application, this research may help optimize rehabilitation strategies and contribute to enhancing patients' functional outcomes in clinical and athletic settings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design:

This is a randomized, controlled, double-blinded clinical trial. Both the evaluator and the participants will be blinded to group allocation. A total of 86 volunteers (aged 18-40 years) will be randomly assigned to one of two intervention groups.

Eligibility Criteria:

Inclusion:

Healthy adults aged 18-40 years No musculoskeletal, neurological, or upper limb conditions Informed consent provided

Exclusion:

Recent physical activity (within 48 hours) Electrotherapy contraindications (e.g., pregnancy, epilepsy, needle phobia) Pain or functional limitations at the time of assessment

Blinding Procedures:

Participants will be unaware of the specific stimulation frequency applied. Since both protocols involve similar sensations and durations, distinguishing between them is unlikely. Evaluations will be performed by a separate physiotherapist who is not informed of the group assignments.

Sample Size Justification:

Based on prior research, a sample size of 43 participants per group (86 in total) is needed to detect statistically significant differences between groups with 80% power and a 5% significance level. Calculations are based on previously reported standard deviations and an expected moderate effect size.

Data Handling and Confidentiality:

All participant data will be pseudonymized using unique identification codes. Only the principal investigator will have access to the code-key linking participants' identities. Data will be stored securely, and all procedures will comply with current data protection regulations.

Potential Risks and Safety Measures:

As an invasive physiotherapy technique, PNM may involve minimal risks such as mild discomfort from the needle insertion, transient pain during electrical stimulation, or minor hematoma formation. However, all interventions will be performed by trained professionals following strict aseptic protocols, using sterile gloves, probe covers, and appropriate skin disinfection procedures. The technique has been previously validated in both healthy and clinical populations, further supporting its safety.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • University of Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged 18-40 years
  • No musculoskeletal, neurological, or upper limb conditions
  • Informed consent provided

Exclusion Criteria:

  • Recent physical activity (within 48 hours)
  • Electrotherapy contraindications (e.g., pregnancy, epilepsy, needle phobia)
  • Pain or functional limitations at the time of assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: US-guided PNM 100Hz/350µs/5s/5c
a protocol of percutaneous neuromodulation of the median nerve consisting of 5 cycles of 5 seconds stimulation (100 Hz and 350 µs pulse width), followed by 55 seconds rest.
Other: US-guided PNM 100 Hz
a protocol of percutaneous neuromodulation of the median nerve consisting of 5 cycles of 5 seconds stimulation (100 Hz and 350 µs pulse width), followed by 55 seconds rest.
Experimental: US-guided PNM 10Hz/250µs/10s/10c
a protocol of percutaneous neuromodulation of the median nerve consisting of 10 cycles of 10 seconds stimulation (10 Hz and 250 µs pulse width), followed by 10 seconds rest.
Other: US-guided PNM 10 Hz
a protocol of percutaneous neuromodulation of the median nerve consisting of 10 cycles of 10 seconds stimulation (10 Hz and 250 µs pulse width), followed by 10 seconds rest.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Handgrip Strength
Time Frame: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.
This variable will be measured using a digital dynamometer
This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain during the intervention
Time Frame: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention
Perceived pain during the intervention, assessed with the Numerical Pain Rating Scale (0-10).
This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pablo Herrero, Physiotherapist, Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMP-e. Handgrip strength

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared on a reasonable request contacting with the main author once data has been published.

Anyway, Individual participant data (IPD) will be shared with other researchers in accordance with data sharing protocols and participant consent, ensuring confidentiality and ethical considerations are maintained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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