NCT06529770

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

July 26, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

PNM-ENeuromodulation

Outcome Measures

Primary Outcomes (1)

  • Maximal Strength (1RM)

    This will be measured using the "shoulder press" exercise.

    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

    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

    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

    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

    Measurements will be conducted in all 4 sessions of the study (day 1, day 7, day 13, and day 21).

Study Arms (3)

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.

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.

Other: NMP-e

Interventions

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.

NMP-e 1 sessionNMP-e 3 sessions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18 and 65 years old
  • Have at least 1 year of experience in CrossFit training

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Canvi Crossfit

Tavernes de la Valldigna, Valencia, 46760, Spain

Location

Universidad de Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (1)

  • 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.

Study Officials

  • Pablo Herrero, Physiotherapist

    Universidad de Zaragoza

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 31, 2024

Study Start

September 15, 2024

Primary Completion

December 12, 2024

Study Completion

December 13, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Once research has been published
Access Criteria
Study protocol will be publish in a scientific journal

Locations