Efficacy of Eco-guided PENS on Handgrip Strength

March 1, 2021 updated by: University of Castilla-La Mancha

Efficacy of Low Frequency Eco-guided Percutaneous Electric Stimulation on Handgrip Strength: A Single-blinded Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single-blind randomized clinical trial of n = 12 healthy subjects. 4 assessments of the grip strength of the non-dominant hand will be made using a digital dynamometer, by a blinded investigator. A V0-pre-intervention, a V1-post-intervention, a V2 at 24 hours and a V3 at 10 days after the intervention. Subjects will be randomly assigned by EPIDAT 3.1, to an experimental group or a control group, with n = 6 each group. In the experimental group, an ultrasound-guided percutaneous electrical stimulation will be performed. With a pointer, a symmetrical biphasic low-frequency current of 10 Hz and 240 microseconds will be applied to the median nerve and ulnar nerve, until reaching the excitomotor threshold, with applications of 10 seconds and rests of 5 seconds until reaching a stimulation of 1 minute. total over each nerve. In the control group, the same invasive procedure will be performed, but no type of electrical stimulation will be applied.

Statistical analysis will be performed by another blinded assessor, using IBM SPSS Statistics 24. A two-factor ANOVA (intervention-time) with Bonferroni correction will be performed.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45071
        • Castilla-La Mancha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: 10 hz stimulatión
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
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.
Sham Comparator: Sham stimulation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand-grip Strength
Time Frame: baseline at 0 minutes
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
baseline at 0 minutes
Hand-grip Strength
Time Frame: Time Frame: immediately after intervention at 1 minute
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
Time Frame: Time Frame: 24 hours after intervention
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Time Frame: 24 hours after intervention
Hand-grip Strength
Time Frame: Time Frame: 10 days after intervention
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Time Frame: 10 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Investigators

  • Study Director: Juan Avendaño-Coy, PhD, Castilla-La Mancha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2020

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PENS-Gifto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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