Electrical StimulationNCT04662229
Efficacy of Eco-guided PENS on Handgrip Strength
A study testing Eco-guided Percutaneous Electrical Stimulation in people with Electrical Stimulation and Neuromodulation, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Stimulation, Neuromodulation
- What is being tested?
- Eco-guided Percutaneous Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2020to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Electrical Stimulation, Neuromodulation
- Being tested
- Eco-guided Percutaneous Electrical Stimulation, Sham stimulation
- Keywords
- PENS, low-frecuency stimulation, handgrip strength, percutamos electrical stimulation, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-grip Strength
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Measured: baseline at 0 minutes
Hand-grip Strength
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Measured: 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.
Measured: Time Frame: 24 hours after intervention
Hand-grip Strength
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Measured: Time Frame: 10 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start12 Dec 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrical StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño-Coy, PhD, Study director, Castilla-La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662229
- Sponsor's protocol ID
- PENS-Gifto
- Status last verified
- Jan 2021
- First submitted
- 3 Dec 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35166034
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Frequency Eco-guided Percutaneous Electric Stimulation on Handgrip Strength: A Single-blinded Pilot Study
- ClinicalTrials.gov ID
- NCT04662229
- Acronym / sponsor ID
- PENS-Gifto
- Conditions
- Electrical Stimulation, Neuromodulation
- Keywords
- PENS, low-frecuency stimulation, handgrip strength, percutamos electrical stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 10 hz stimulatión | Experimental | Device: Eco-guided Percutaneous Electrical StimulationEco-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. |
| Sham stimulation | Sham comparator | Device: Sham stimulationApplication 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb.
- Osteosynthesis material in the upper limb.
- Diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eco-guided Percutaneous Electrical StimulationPointer 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. | Device | Experimental: 10 hz stimulatión |
| Sham stimulationApplication 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. | Device | Sham stimulation |
Primary outcome
Hand-grip Strength
Time frame: baseline at 0 minutes
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 35166034Alvarez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Avendaño-Coy, PhD study director
Castilla-La Mancha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eco-guided Percutaneous Electrical Stimulation in people with Electrical Stimulation and Neuromodulation, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-grip Strength (time frame: baseline at 0 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.