HealthyNCT06529770
Ultrasound-Guided Percutaneous Neuromodulation in the Strength of CrossFit Athletes
A study testing NMP-e in people with Healthy and CrossFit, run by Universidad de Zaragoza at 2 sites in Spain.
Trial summary
The origin of CrossFit (CF) dates back to 1995 when Greg Glassman opened the first facility dedicated to the sport he named CF in Santa Cruz, California. However, the dissemination and promotion of this sport began in 2000 with the creation of the CF brand alongside his wife Lauren Jenai. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- NMP-e
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Sep 2024to 13 Dec 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between 18 and 65 years old
- Have at least 1 year of experience in CrossFit training
Who cannot join
- Have not undergone any previous surgeries
- Have no pathology that causes any type of pain
- Have no physical impairment that would hinder dynamometry measurements (muscle injuries, joint instability, joint inflammation, etc.)
- Have no contraindications for the application of Ultrasound-Guided Percutaneous Neuromodulation (US-PNM) such as trypanophobia, pregnancy, epilepsy, or pacemakers.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Canvi Crossfit
Tavernes de la Valldigna, Valencia, 46760
Universidad de Zaragoza
Zaragoza, Zaragoza, 50009
About this study
Official title: Benefits of Ultrasound-Guided Percutaneous Neuromodulation on the Strength of CrossFit Athletes
The origin of CrossFit (CF) dates back to 1995 when Greg Glassman opened the first facility dedicated to the sport he named CF in Santa Cruz, California. However, the dissemination and promotion of this sport began in 2000 with the creation of the CF brand alongside his wife Lauren Jenai. Today, the brand generates around 100 million euros annually and has a market valuation of approximately 4 billion euros. CF boasts 14,000 boxes in 155 countries, with over five million users. Spain ranks as the fifth country with the most CF centers.
CF training focuses on constantly varied functional movements, including gymnastics, weightlifting exercises, and cardiovascular activities (e.g., running or rowing). Variety is one of the main attractions for participants, as the workouts are short, intense, and diverse.
Read more
Within invasive physiotherapy, there is the technique of ultrasound-guided percutaneous neuromodulation (US-PNM), which enhances muscle function, muscle recruitment patterns, and motor control. This minimally invasive intervention involves the application of percutaneous electrical stimulation through an electrode similar to an acupuncture needle, placed in close proximity to the nerve or motor point of the target muscle under ultrasound guidance. Performing this technique under ultrasound guidance is recommended as it makes the procedure safer and more effective, allowing real-time visualization of needle positioning and technique application.
Most studies on US-PNM have focused on pain treatment in patients, but some studies have explored its benefits in healthy individuals. For instance, De-la-Cruz-Torre et al. demonstrated that applying this procedure to the sciatic nerve can increase hamstring flexibility; De-la-Cruz-Torres et al. also reported an increase in the performance of the flexor hallucis longus muscle in dancers; Álvarez-Prats et al. showed an improvement in quadriceps muscle strength after performing electrical stimulation on the femoral nerve; and Gallego-Sendarrubias et al. suggested an enhancement in performance skills in soccer players by applying the neuromodulation procedure to the femoral nerve before specific strength training.
Overall, the literature suggests that US-PNM intervention improves strength levels, but the results should be confirmed with future research due to sample size limitations and short-term evaluations. Additionally, there are currently no studies on the application of US-PNM in a sample of CF athletes. Therefore, the objective of this study is to analyze the effectiveness and duration of the effects of two US-PNM protocols applied to the axillary and suprascapular nerves on shoulder rotation strength in healthy CF athletes.
Read the detailed description
The study aims to:
- Analyze whether 3 sessions of ultrasound-guided percutaneous neuromodulation (US-PNM) are more effective than 1 session of US-PNM for shoulder rotation muscle strength in healthy CrossFit athletes.
- Analyze whether the US-PNM intervention has a positive effect on the ability to perform a one-repetition maximum (1RM) in a functional CF movement, such as the "Shoulder Press," in healthy CrossFit athletes.
To achieve this, a randomized clinical trial is proposed with three study groups:
- Control group: no intervention will be performed.
- Experimental group 1 session US-PNM: will receive 1 session of US-PNM.
- Experimental group 3 sessions US-PNM: will receive 3 sessions of US-PNM, with one week of separation between each session.
- Being tested
- NMP-e
- Keywords
- PNM-E, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMP-eOther
The US-PNM intervention uses a square-wave biphasic current (10 Hz, 250 ms pulse width) at maximum tolerable intensity for 1.5 minutes (10 seconds 10 times), per Fermín Valera and Fran Minaya's protocol. Participants will lie on their side, with the area cleaned and an ultrasound probe cover used.
Needles (Agu Punt, Spain) will be inserted perpendicularly to target the nerve perineurium. For the axillary nerve (C5-C6), a 0.40/0.50×25 mm needle will be used in a short axis at 80°. For the suprascapular nerve (C5-C6), a 0.30/0.40×25 mm needle will be used.
Each session involves two needle insertions, with the needle stationary and monitored by a physiotherapist with two years of experience.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The group receives no intervention |
| NMP-e 3 sessions | Experimental | The group receives 1 session of ultrasound-guided percutaneous neuromodulation. The session wil be received at day 1 of the study. Receives: Other: NMP-e |
| NMP-e 1 session | Experimental | The group receives 3 sessions of ultrasound-guided percutaneous neuromodulation. The sessions wil be received at day 1, 7 and 14 of the study. Receives: Other: NMP-e |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Strength (1RM)
This will be measured using the "shoulder press" exercise.
Measured: Measurements will be taken only on the first and last days of the sessions (day 1 and day 21).
Secondary outcomes (4)
Internal Shoulder Rotator Muscle Strength. 0º abduction
Internal shoulder rotation at 0º of shoulder abduction will be measured using dynamometry (Active Force 2), with data collected digitally on the principal investigator's computer.
Measured: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
Internal Shoulder Rotator Muscle Strength. 90º abduction
Internal shoulder rotation at 90º of shoulder abduction will be measured using dynamometry (Active Force 2), with data collected digitally on the principal investigator's computer.
Measured: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
External Shoulder Rotator Muscle Strength. 0º abduction
External shoulder rotation at 0º of shoulder abduction will be measured using dynamometry (Active Force 2), with data collected digitally on the principal investigator's computer.
Measured: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
External Shoulder Rotator Muscle Strength. 90º abduction
External shoulder rotation at 0º of shoulder abduction will be measured using dynamometry (Active Force 2), with data collected digitally on the principal investigator's computer.
Measured: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start15 Sep 2024
- Primary completion12 Dec 2024
- Study completion13 Dec 2024
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 HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT06529770
- Sponsor's protocol ID
- NMP-e.CF
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2024
- Last updated
- 18 Dec 2024
- 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
Sangiacomo R, Valera-Garrido F, Minaya-Munoz F, Carcasona-Otal A, Herrero P, Lapuente-Hernandez D. Effects of Ultrasound-Guided Percutaneous Neuromodulation on Shoulder Muscle Strength in CrossFit Athletes: A Pilot Randomized Controlled Trial. Neuromodulation. 2025 Jun;28(4):600-610. doi: 10.1016/j.neurom.2025.03.072. Epub 2025 Apr 3.
PubMed 40183726
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Ultrasound-Guided Percutaneous Neuromodulation on the Strength of CrossFit Athletes
- ClinicalTrials.gov ID
- NCT06529770
- Acronym / sponsor ID
- NMP-e.CF
- Keywords
- PNM-E, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 31 Jul 2024 (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.
The origin of CrossFit (CF) dates back to 1995 when Greg Glassman opened the first facility dedicated to the sport he named CF in Santa Cruz, California. However, the dissemination and promotion of this sport began in 2000 with the creation of the CF brand alongside his wife Lauren Jenai. Today, the brand generates around 100 million euros annually and has a market valuation of approximately 4 billion euros. CF boasts 14,000 boxes in 155 countries, with over five million users. Spain ranks as the fifth country with the most CF centers.
CF training focuses on constantly varied functional movements, including gymnastics, weightlifting exercises, and cardiovascular activities (e.g., running or rowing). Variety is one of the main attractions for participants, as the workouts are short, intense, and diverse.
Within invasive physiotherapy, there is the technique of ultrasound-guided percutaneous neuromodulation (US-PNM), which enhances muscle function, muscle recruitment patterns, and motor control. This minimally invasive intervention involves the application of percutaneous electrical stimulation through an electrode similar to an acupuncture needle, placed in close proximity to the nerve or motor point of the target muscle under ultrasound guidance. Performing this technique under ultrasound guidance is recommended as it makes the procedure safer and more effective, allowing real-time visualization of needle positioning and technique application.
Most studies on US-PNM have focused on pain treatment in patients, but some studies have explored its benefits in healthy individuals. For instance, De-la-Cruz-Torre et al. demonstrated that applying this procedure to the sciatic nerve can increase hamstring flexibility; De-la-Cruz-Torres et al. also reported an increase in the performance of the flexor hallucis longus muscle in dancers; Álvarez-Prats et al. showed an improvement in quadriceps muscle strength after performing electrical stimulation on the femoral nerve; and Gallego-Sendarrubias et al. suggested an enhancement in performance skills in soccer players by applying the neuromodulation procedure to the femoral nerve before specific strength training.
Overall, the literature suggests that US-PNM intervention improves strength levels, but the results should be confirmed with future research due to sample size limitations and short-term evaluations. Additionally, there are currently no studies on the application of US-PNM in a sample of CF athletes. Therefore, the objective of this study is to analyze the effectiveness and duration of the effects of two US-PNM protocols applied to the axillary and suprascapular nerves on shoulder rotation strength in healthy CF athletes.
Detailed description
The study aims to:
- Analyze whether 3 sessions of ultrasound-guided percutaneous neuromodulation (US-PNM) are more effective than 1 session of US-PNM for shoulder rotation muscle strength in healthy CrossFit athletes.
- Analyze whether the US-PNM intervention has a positive effect on the ability to perform a one-repetition maximum (1RM) in a functional CF movement, such as the "Shoulder Press," in healthy CrossFit athletes.
To achieve this, a randomized clinical trial is proposed with three study groups:
- Control group: no intervention will be performed.
- Experimental group 1 session US-PNM: will receive 1 session of US-PNM.
- Experimental group 3 sessions US-PNM: will receive 3 sessions of US-PNM, with one week of separation between each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The group receives no intervention |
| NMP-e 3 sessions | Experimental | Other: NMP-eThe group receives 1 session of ultrasound-guided percutaneous neuromodulation. The session wil be received at day 1 of the study. |
| NMP-e 1 session | Experimental | Other: NMP-eThe group receives 3 sessions of ultrasound-guided percutaneous neuromodulation. The sessions wil be received at day 1, 7 and 14 of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be between 18 and 65 years old
- Have at least 1 year of experience in CrossFit training
Key exclusion criteria (4 listed)
- Have not undergone any previous surgeries
- Have no pathology that causes any type of pain
- Have no physical impairment that would hinder dynamometry measurements (muscle injuries, joint instability, joint inflammation, etc.)
- Have no contraindications for the application of Ultrasound-Guided Percutaneous Neuromodulation (US-PNM) such as trypanophobia, pregnancy, epilepsy, or pacemakers.
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 |
|---|---|---|
| NMP-eThe US-PNM intervention uses a square-wave biphasic current (10 Hz, 250 ms pulse width) at maximum tolerable intensity for 1.5 minutes (10 seconds 10 times), per Fermín Valera and Fran Minaya's protocol. Participants will lie on their side, with the area cleaned and an ultrasound probe cover used. Needles (Agu Punt, Spain) will be inserted perpendicularly to target the nerve perineurium. For the axillary nerve (C5-C6), a 0.40/0.50×25 mm needle will be used in a short axis at 80°. For the suprascapular nerve (C5-C6), a 0.30/0.40×25 mm needle will be used. Each session involves two needle insertions, with the needle stationary and monitored by a physiotherapist with two years of experience. | Other | NMP-e 1 session, NMP-e 3 sessions |
Primary outcome
Maximal Strength (1RM)
Time frame: Measurements will be taken only on the first and last days of the sessions (day 1 and day 21).
This will be measured using the "shoulder press" exercise.
4 secondary outcomes
Internal Shoulder Rotator Muscle Strength. 0º abduction
Time frame: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
Internal Shoulder Rotator Muscle Strength. 90º abduction
Time frame: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
External Shoulder Rotator Muscle Strength. 0º abduction
Time frame: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
External Shoulder Rotator Muscle Strength. 90º abduction
Time frame: Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
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 18 Dec 2024.
- Derived from this study: PubMed 40183726Sangiacomo R, Valera-Garrido F, Minaya-Munoz F, Carcasona-Otal A, Herrero P, Lapuente-Hernandez D. Effects of Ultrasound-Guided Percutaneous Neuromodulation on Shoulder Muscle Strength in CrossFit Athletes: A Pilot Randomized Controlled Trial. Neuromodulation. 2025 Jun;28(4):600-610. doi: 10.1016/j.neurom.2025.03.072. Epub 2025 Apr 3.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMP-e in people with Healthy and CrossFit, run by Universidad de Zaragoza at 2 sites 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 2 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Maximal Strength (1RM) (time frame: Measurements will be taken only on the first and last days of the sessions (day 1 and day 21).). 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 NCT06529770, 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 18 Dec 2024.