NCT03150823

Brief Summary

Electrical stimulation currently has a wide range of clinical applications, being used for activities such as strengthening, pain control, edema management, or inflammation control after injury or surgery. One of the classic forms of electrotherapy is the Direct current (galvanic current), which stands out for its unique effects (polar and interpolar effects) and that are not achieved with other modalities of electrotherapy. Within these effects those activators or suppressors of nervous system activity are described. One of the applications of direct current is to produce sedation or excitation on the nervous system through longitudinal applications (longitudinal galvanization). This application technique is known as the upstream or downstream effect of the direct current or "Leduc Effect", in which it is postulated that an ascending type longitudinal galvanization has excitation effects of the central and / or peripheral nervous system. The study will evaluate the influence of the upward and downward direct current effect when performing a manual dynamometer test while monitoring by miofeedback in college students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
Last Updated

September 12, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

May 9, 2017

Last Update Submit

September 10, 2018

Conditions

Keywords

Direct currentGalvanic currentHandgrip ForcePalmar GripDynamometryMiofeedback

Outcome Measures

Primary Outcomes (2)

  • Difference of Maximum handgrip force

    Comparing maximum handgrip strength pre and post application of upward and downward direct current intervention

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

  • Difference of Maximum Electromiographic Activation Threshold

    Comparing maximum Electromiographic Activation pre and post application of upward and downward direct current intervention

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

Study Arms (3)

Upward Direct Current (Ascending Effect)

EXPERIMENTAL

Group subjected to a direct current application (Longitudinal Galvanization) in which the anode is placed at the distal level and the cathode at the proximal level. This would be an excitatory effect of the nervous system.

Procedure: Upward Direct Current (Ascending Effect)

Downward Direct Current (Descending Effect)

EXPERIMENTAL

Group subjected to a direct current application (Longitudinal Galvanization) in which the cathode is placed at the distal level and the anode at the proximal level. This would be an inhibitory effect of the nervous system.

Procedure: Downward Direct Current (Descending Effect)

Sham Direct Current

SHAM COMPARATOR

Group to which an electrical installation will be carried out without emission of part of the electrotherapy equipment. The electrodes will be applied longitudinally to the participants with the equipment switched off.

Procedure: Sham Direct Current

Interventions

Application of direct current (Galvanic) in milliamperes current which varies according to the positioning of the electrodes. In the ascending stream direct current (Ascending effect) the proximal cathode and distal anode are placed, a excitatory effect on the nervous system being described in theory.

Upward Direct Current (Ascending Effect)

Application of direct current (Galvanic) in milliamperes current which varies according to the positioning of the electrodes. In the descending stream direct current (Descending effect) the proximal anode and distal cathode are placed, a sedative and analgesic effect on the nervous system being described in theory.

Downward Direct Current (Descending Effect)

Installation of electrotherapy equipment off (Sham tratment).

Sham Direct Current

Eligibility Criteria

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

You may qualify if:

  • Students of the Faculty of Rehabilitation Sciences.
  • Participants older than 18 years of age.
  • Participants who do not show discomfort or pain when performing manual grip in the dominant hand.

You may not qualify if:

  • Musculoskeletal pathologies of hand, wrist or elbow in the last 6 months.
  • Materials of osteosynthesis or prosthesis in areas of application.
  • Peripheral neurological pathologies such as or nerve compression cuts.
  • Sensitivity alterations such as hypoesthesia, anesthesia or hyperesthesia in the upper limbs.
  • Alterations in the skin of the application areas, such as burns, wounds, scars.
  • Apprehension or fear of the application of electrotherapy.
  • Non-completion of the evaluation / intervention protocol, designed for the study or abandonment of the same.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Andrés Bello

Santiago, Las Condes, 7591538, Chile

Location

Related Publications (21)

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

    BACKGROUND
  • Rodríguez Martin JM, Galvanismo V. En J. Rodríguez, Electroterapia en fisioterapia. 2 Edición. Madrid: Editorial Médica Panamericana, 2004.

    BACKGROUND
  • Avendaño Coy, A. Ferri Morales, E. Sánchez Sobrados, A. Ceciaga Ajuria. Efectos de la galvanización sobre el umbral excitomotor. Estudio sobre individuos sanos. Rev Iberoam Fisioter Kinesiol 2001;4(1):00-00.

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

    PMID: 6728918BACKGROUND
  • 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
  • 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
  • Galvani, L. Opere edite ed inedite del Professore Luigi Galvani raccolte e pubblicate dall'Accademia delle Science dell'Istituto di Bologna. Bologna: Dall'Olmo; 1841.

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

    BACKGROUND
  • Watanabe T, Owashi K, Kanauchi Y, Mura N, Takahara M, Ogino T. The short-term reliability of grip strength measurement and the effects of posture and grip span. J Hand Surg Am. 2005 May;30(3):603-9. doi: 10.1016/j.jhsa.2004.12.007.

    PMID: 15925174BACKGROUND
  • O'Driscoll SW, Horii E, Ness R, Cahalan TD, Richards RR, An KN. The relationship between wrist position, grasp size, and grip strength. J Hand Surg Am. 1992 Jan;17(1):169-77. doi: 10.1016/0363-5023(92)90136-d.

    PMID: 1538102BACKGROUND
  • Innes E. Handgrip strength testing: A review of the literature. Aust Occup Ther J 1999; 46(3):120-140.)

    BACKGROUND
  • Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S. Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil. 1985 Feb;66(2):69-74.

    PMID: 3970660BACKGROUND
  • Kozin SH, Porter S, Clark P, Thoder JJ. The contribution of the intrinsic muscles to grip and pinch strength. J Hand Surg Am. 1999 Jan;24(1):64-72. doi: 10.1053/jhsu.1999.jhsu24a0064.

    PMID: 10048518BACKGROUND
  • 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
  • Margin del Socorro Martínez Matheus, Principios de Electroestimulación y terminología Electroterapéutica Primea edición Bogotá año 2006 P, 34 a 39.

    BACKGROUND
  • McNeal DR: 2000 years of electrical stimulation. In: Hambrecht FT Ryswick JB, eds: Functional Electrical Stimulation: Applications Neural Prostheses, New York, 1977 Marcel Dekker.

    BACKGROUND
  • Volta, A. Le opere di Alessandro Volta (edizione nazionale), I vol. Milano; Hoepli; 1918.

    BACKGROUND

Study Officials

  • Hernán Andrés A de la Barra Ortiz, Mg.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Clinical Professor

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 12, 2017

Study Start

June 26, 2017

Primary Completion

August 26, 2017

Study Completion

August 2, 2018

Last Updated

September 12, 2018

Record last verified: 2018-08

Locations