Healthy ParticipantsNCT07098130
Comparative Study of Two Ultrasound-guided Percutaneous Neuromodulation Protocols on Maximal Handgrip Strength.
A study testing US-guided PNM 100 Hz and US-guided PNM 10 Hz in people with Healthy Participants, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- US-guided PNM 100 Hz and US-guided PNM 10 Hz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 27 Nov 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-40 years
- No musculoskeletal, neurological, or upper limb conditions
- Informed consent provided
Who cannot join
- Recent physical activity (within 48 hours)
- Electrotherapy contraindications (e.g., pregnancy, epilepsy, needle phobia)
- Pain or functional limitations at the time of assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- US-guided PNM 100 Hz, US-guided PNM 10 Hz
- Keywords
- Neromodulation, Percutaneous, Ultrasound, handgrip strength, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided PNM 100 HzOther
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.
US-guided PNM 10 HzOther
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.
| Study group | Role | What they receive |
|---|---|---|
| US-guided PNM 100Hz/350µs/5s/5c | Experimental | 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. Receives: Other: US-guided PNM 100 Hz |
| US-guided PNM 10Hz/250µs/10s/10c | Experimental | 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. Receives: Other: US-guided PNM 10 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Handgrip Strength
This variable will be measured using a digital dynamometer
Measured: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.
Secondary outcomes (1)
Pain during the intervention
Perceived pain during the intervention, assessed with the Numerical Pain Rating Scale (0-10).
Measured: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pablo Herrero Gallego, Universidad de Zaragoza
- Investigators
- Pablo Herrero, Physiotherapist, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098130
- Sponsor's protocol ID
- NMP-e. Handgrip strength
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Barbosa da Silva HM, Valera-Garrido F, Minaya-Munoz F, Alvarez-Prats D, Lapuente-Hernandez D, Herrero P, Carcasona-Otal A, Carvajal-Fernandez O. Comparison of Two Ultrasound-Guided Percutaneous Neuromodulation Protocols Applied to the Median Nerve on Maximal Handgrip Strength in Healthy Adults: A Randomized Clinical Trial. Neuromodulation. 2026 Apr 11:S1094-7159(26)00062-0. doi: 10.1016/j.neurom.2026.03.005. Online ahead of print.
PubMed 41964624
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Ultrasound-guided Percutaneous Neuromodulation Protocols on Maximal Handgrip Strength: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07098130
- Acronym / sponsor ID
- NMP-e. Handgrip strength
- Conditions
- Healthy Participants
- Keywords
- Neromodulation, Percutaneous, Ultrasound, handgrip strength, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 1 Aug 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided PNM 100Hz/350µs/5s/5c | Experimental | Other: US-guided PNM 100 Hza 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. |
| US-guided PNM 10Hz/250µs/10s/10c | Experimental | Other: US-guided PNM 10 Hza 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18-40 years
- No musculoskeletal, neurological, or upper limb conditions
- Informed consent provided
Key exclusion criteria (3 listed)
- Recent physical activity (within 48 hours)
- Electrotherapy contraindications (e.g., pregnancy, epilepsy, needle phobia)
- Pain or functional limitations at the time of assessment
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 |
|---|---|---|
| US-guided PNM 100 Hza 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 100Hz/350µs/5s/5c |
| US-guided PNM 10 Hza 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 10Hz/250µs/10s/10c |
Primary outcome
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
1 secondary outcome
Pain during the intervention
Time frame: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention
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 1 Dec 2025.
- Derived from this study: PubMed 41964624Barbosa da Silva HM, Valera-Garrido F, Minaya-Munoz F, Alvarez-Prats D, Lapuente-Hernandez D, Herrero P, Carcasona-Otal A, Carvajal-Fernandez O. Comparison of Two Ultrasound-Guided Percutaneous Neuromodulation Protocols Applied to the Median Nerve on Maximal Handgrip Strength in Healthy Adults: A Randomized Clinical Trial. Neuromodulation. 2026 Apr 11:S1094-7159(26)00062-0. doi: 10.1016/j.neurom.2026.03.005. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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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.
Pablo Herrero, Physiotherapist study director
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided PNM 100 Hz and US-guided PNM 10 Hz in people with Healthy Participants, run by Universidad de Zaragoza 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 3 inclusion and 3 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 1 Dec 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?
Maximum Handgrip Strength (time frame: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07098130, which also lists 1 linked publication.
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 1 Dec 2025.