Efficacy of Eco-guided PENS on Handgrip Strength

Neuromodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662229
• Other study ID #: PENS-Gifto
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: January 2021
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrical Stimulation
• Neuromodulation

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Castilla-La Mancha University	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand-grip Strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	baseline at 0 minutes
Primary	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
Primary	Hand-grip Strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	Time Frame: 24 hours after intervention
Primary	Hand-grip Strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	Time Frame: 10 days after intervention