NCT02884427

Brief Summary

The design aims to investigate the value of direct current, specifically the polar effects this has, and its influence on neuromuscular changes described in the literature. This research proposal seeks to assess the influence of application anode and cathode pole in muscle strength when testing handgrip dynamometry by healthy subjects. The study will evaluate changes in muscle strength when performing a manual dynamometer test in a group exposed to the application of cathode, another exposed to the application of anode, compared with a control that will not receive the intervention will be evaluated. Subsequently the investigators proceed to compare the maximum force obtained from the dynamometry test in each of groups and between the groups .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 14, 2017

Completed
Last Updated

October 9, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

August 15, 2016

Results QC Date

December 25, 2016

Last Update Submit

September 10, 2018

Conditions

Handgrip Strength

Keywords

Direct currentDynamometryHand strengthElectrotherapyTranscutaneous Electric Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • Difference of Maximum Grip Strength

    The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.

    Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.

Secondary Outcomes (2)

  • Difference of Maximum Grip Strength for Males

    Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.

  • Difference of Maximum Grip Strength for Females

    Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.

Study Arms (3)

Cathode Stimulation

EXPERIMENTAL

Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.

Device: Cathode stimulation

Anode Stimulation

EXPERIMENTAL

Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.

Device: Anode stimulation

Control

PLACEBO COMPARATOR

Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.

Device: Placebo

Interventions

Cathode stimulationDEVICE

Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.

Also known as: Cathode Polar effect
Cathode Stimulation
Anode stimulationDEVICE

Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.

Also known as: Anode Polar effect
Anode Stimulation
PlaceboDEVICE

Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.

Also known as: Non intervention
Control

Eligibility Criteria

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

You may qualify if:

  • Participants older than 18 years
  • Do not manifest discomfort or pain when performing the handgrip.

You may not qualify if:

  • Skeletal muscle pathologies in hand, wrist or elbow in the last 6 months.
  • Materials osteosynthesis or endoprosthesis in areas of application.
  • Peripheral neurological pathologies as neuropraxias or nerve sections.
  • Changes in the skin of the application areas, such as burns, wounds, scars.
  • Apprehension or fear of the application of electrotherapy.
  • No completion of the evaluation protocol / intervention, designed for study or abandonment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Andrés Bello

Santiago, Las Condes, 7591538, Chile

Location

Related Publications (17)

  • Michelle H. Cameron, Physical Agents in Rehabilitations 2003, Elsevier. Cap. VIII, P, 220.

    BACKGROUND

  • Currier DP, Mann R. Muscular strength development by electrical stimulation in healthy individuals. Phys Ther. 1983 Jun;63(6):915-21. doi: 10.1093/ptj/63.6.915.

    PMID: 6856678BACKGROUND

  • Thurin E, Meehan PF, Gilbert BS. Treatment of pain by transcutaneous electric nerve stimulation in general practice. Med J Aust. 1980 Jan 26;1(2):70-1. doi: 10.5694/j.1326-5377.1980.tb134629.x.

    PMID: 6965758BACKGROUND

  • Rodríguez Martin JM, Corrientes más utilizadas en la Electroterapia en Fisioterapia. Editorial Medica Panamericana, Cap II, P. 61- 86, 2000.

    BACKGROUND

  • Glass JM, Stephen RL, Jacobson SC. The quantity and distribution of radiolabeled dexamethasone delivered to tissue by iontophoresis. Int J Dermatol. 1980 Nov;19(9):519-25. doi: 10.1111/j.1365-4362.1980.tb00380.x.

    PMID: 7429701BACKGROUND

  • Conjeevaram R, Banga AK, Zhang L. Electrically modulated transdermal delivery of fentanyl. Pharm Res. 2002 Apr;19(4):440-4. doi: 10.1023/a:1015135426838.

    PMID: 12033377BACKGROUND

  • Petelenz TJ, Buttke C, Bonds LB, Lloyd JE, Beck RL, Stephens SC. Iontophoresis of dexamethasone: laboratory studies. J Controll Rel 1992;20:55-66.

    BACKGROUND

  • Fujita M, Hukuda S, Doida Y. The effect of constant direct electrical current on intrinsic healing in the flexor tendon in vitro. An ultrastructural study of differing attitudes in epitenon cells and tenocytes. J Hand Surg Br. 1992 Feb;17(1):94-8. doi: 10.1016/0266-7681(92)90021-s.

    PMID: 1640154BACKGROUND

  • Raiman J, Koljonen M, Huikko K, Kostiainen R, Hirvonen J. Delivery and stability of LHRH and Nafarelin in human skin: the effect of constant/pulsed iontophoresis. Eur J Pharm Sci. 2004 Feb;21(2-3):371-7. doi: 10.1016/j.ejps.2003.11.003.

    PMID: 14757511BACKGROUND

  • Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):619-58. doi: 10.1016/j.addr.2003.10.026.

    PMID: 15019750BACKGROUND

  • Panus PC, Ferslew KE, Tober-Meyer B, Kao RL. Ketoprofen tissue permeation in swine following cathodic iontophoresis. Phys Ther. 1999 Jan;79(1):40-9.

    PMID: 9920190BACKGROUND

  • Meijinde Faide R. Rodriguez .Villamil Fernandez JLy Teiro Vidal J. Corrientes Galvanicas En. Martinez Morillo M, Pastor Vega, y Sandra Portero F. Manual de Medicina Fisica Harcourt Brace España 1998 P150-68.

    BACKGROUND

  • Kvandal P, Stefanovska A, Veber M, Kvernmo HD, Kirkeboen KA. Regulation of human cutaneous circulation evaluated by laser Doppler flowmetry, iontophoresis, and spectral analysis: importance of nitric oxide and prostaglandines. Microvasc Res. 2003 May;65(3):160-71. doi: 10.1016/s0026-2862(03)00006-2.

    PMID: 12711257BACKGROUND

  • Guy RH, Delgado-Charro MB, Kalia YN. Iontophoretic transport across the skin. Skin Pharmacol Appl Skin Physiol. 2001;14 Suppl 1:35-40. doi: 10.1159/000056388.

    PMID: 11509905BACKGROUND

  • Calvo Arenilla JI, Rubio López I. Iontoforesis. Aplicaciones de la Iontoforesis. Electroestimulaciónaplicada. En: Meaños Melón E, Alonso Martínez M, Murga Rodríguez F, Pinsach Ametller J, et al. Vigo: Obradoiro Gráfico; 2003. p. 157-172.

    BACKGROUND

  • Kahn J. Iontophoresis. Phys Ther. 1984 Jun;64(6):956, 959. doi: 10.1093/ptj/64.6.956a. No abstract available.

    PMID: 6728918BACKGROUND

  • Oh SY, Guy RH. Effects of iontophoresis on electrical properties of human skin in vivo. Int J Pharmacol 1995;124:137-42.

    BACKGROUND

Results Point of Contact

Title
Professor Hernán Andrés de la Barra O., DC,PT,Mg
Organization
Universidad Andrés Bello
quiropraxiayequilibrio@gmail.com
56226618402

Study Officials

  • Hernán Andrés HB de la Barra Ortiz, Mg.

    University Teacher and Physical therapist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 31, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

October 9, 2018

Results First Posted

July 14, 2017

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)