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

NCT07098130 | Completed DMC

• 1 other identifier: NMP-e. Handgrip strength
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Participants

Keywords

Neromodulation; Percutaneous; Ultrasound; handgrip strength; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Maximum Handgrip Strength

  This variable will be measured using a digital dynamometer

  This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.

Secondary Outcomes (1)

• Pain during the intervention

  This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention

Study Arms (2)

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.

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.

Other: US-guided PNM 10 Hz

Interventions

US-guided PNM 100 Hz OTHER

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 100Hz/350µs/5s/5c

US-guided PNM 10 Hz OTHER

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.

US-guided PNM 10Hz/250µs/10s/10c

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

Study Officials

• Pablo Herrero, Physiotherapist

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 27, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)