- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06529770
Ultrasound-Guided Percutaneous Neuromodulation in the Strength of CrossFit Athletes
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.
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zaragoza, Spain, 50009
- Universidad de Zaragoza
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Valencia
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Tavernes de la Valldigna, Valencia, Spain, 46760
- Canvi Crossfit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be between 18 and 65 years old
- Have at least 1 year of experience in CrossFit training
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
The group receives no intervention
|
|
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Experimental: NMP-e 3 sessions
The group receives 1 session of ultrasound-guided percutaneous neuromodulation.
The session wil be received at day 1 of the study.
|
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. |
|
Experimental: NMP-e 1 session
The group receives 3 sessions of ultrasound-guided percutaneous neuromodulation.
The sessions wil be received at day 1, 7 and 14 of the study.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Measurements will be taken only on the first and last days of the sessions (day 1 and day 21).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 rotation at 0º of shoulder abduction will be measured using dynamometry (Active Force 2), with data collected digitally on the principal investigator's computer.
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Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
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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).
|
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.
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Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
|
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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).
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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.
|
Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
|
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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).
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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.
|
Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pablo Herrero, Physiotherapist, Universidad de Zaragoza
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NMP-e.CF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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