NCT04662229

Brief Summary

Low-frequency percutaneous electrical stimulation is the application of an electrical current of \<1000Hz through acupuncture needles located on the epineurium of the peripheral nervous system. The hypothesis is that by placing the electrode, needle, closer to the nerve, a greater stimulation of the same will be achieved, thus being able to obtain greater effects. The goal is to determine if this technique has any effect on grip strength in the short term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

December 12, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
Last Updated

March 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

December 3, 2020

Last Update Submit

March 1, 2021

Conditions

Electrical StimulationNeuromodulation

Keywords

PENSlow-frecuency stimulationhandgrip strengthpercutamos electrical stimulationNeuromodulation

Outcome Measures

Primary Outcomes (4)

  • Hand-grip Strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    baseline at 0 minutes

  • Hand-grip Strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    Time Frame: immediately after intervention at 1 minute

  • Hand-grip Strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    Time Frame: 24 hours after intervention

  • Hand-grip Strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    Time Frame: 10 days after intervention

Study Arms (2)

Experimental: 10 hz stimulatión

EXPERIMENTAL

Eco-guided percutaneous electrical stimulation application of low frequency electrical current at 10 hz, 240 microsecond, over the median and ulnar nerve in the arm, for 1 minute on each nerve. The intensity of the current will reach the excitomotor threshold, causing visible but comfortable contractions.

Device: Eco-guided Percutaneous Electrical Stimulation

Sham stimulation

SHAM COMPARATOR

Application of the needles only on the median and ulnar nerve of the arm, for 1 minute on each nerve without current intensity and a sound will be applied.

Device: Sham stimulation

Interventions

Eco-guided Percutaneous Electrical StimulationDEVICE

Pointer 10 hz. A symetric, biphasic current of 10 hz and 240 microsecond. The stimulation intensity will be reaching the excitomotor threshold, producing visible but comfortable contractions.

Experimental: 10 hz stimulatión
Sham stimulationDEVICE

Application of the needles only on the median and ulnar nerve of the arm, for 1 minute on each nerve without current intensity and applying a son.

Sham stimulation

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers
  • Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
  • Tolerance to the application of electrotherapy.
  • That they have not diagnosed any pathology.
  • They do not present a contraindication to puncture and / or the application of electric currents.

You may not qualify if:

  • Neuromuscular disease.
  • Epilepsy.
  • Trauma, surgery or pain affecting the upper limb.
  • Osteosynthesis material in the upper limb.
  • Diabetes.
  • Cancer.
  • Cardiovascular disease.
  • Pacemaker or other implanted electrical device.
  • Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
  • Presence of tattoos or other external agent introduced into the treatment or assessment area.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castilla-La Mancha University

Toledo, 45071, Spain

Location

Related Publications (1)

  • Alvarez DM, Serrano-Munoz D, Fernandez-Perez JJ, Moreno JS, Gomez-Soriano J, Avendano-Coy J. The effect on handgrip strength of low-frequency percutaneous electric stimulation applied to the median and cubital nerves: A randomized, double-blind controlled trial. Anat Rec (Hoboken). 2023 Apr;306(4):720-727. doi: 10.1002/ar.24887. Epub 2022 Feb 15.

    PMID: 35166034DERIVED

Study Officials

  • Juan Avendaño-Coy, PhD

    Castilla-La Mancha University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 10, 2020

Study Start

December 12, 2020

Primary Completion

January 12, 2021

Study Completion

January 12, 2021

Last Updated

March 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)