NCT01696149

Brief Summary

The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic skin response (SSR) and skin temperature.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

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

Study Start

First participant enrolled

March 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

September 18, 2012

Last Update Submit

September 27, 2012

Conditions

Effects of TENS on Sympathetic Skin Response

Keywords

TENS, sympathetic skin response, skin temperature

Outcome Measures

Primary Outcomes (1)

  • Changes of sympathetic skin response

    Sympathetic skin response from the simulated (Right) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.

    15 seconds before, just 15 seconds after, and 10 minutes after application of interventions

Secondary Outcomes (1)

  • Changes of skin temperature

    15 seconds before, just 15 seconds after, and 10 minutes after application of interventions

Study Arms (1)

electrical nerve stimulation

EXPERIMENTAL

All subjects participated, randomly, in a 4 Hz transcutaneous electrical nerve stimulation session, a 110 Hz transcutaneous electrical nerve stimulation session, and a control (off-transcutaneous electrical nerve stimulation) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period

Device: transcutaneous electrical nerve stimulation

Interventions

transcutaneous electrical nerve stimulationDEVICE

All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.

Also known as: TENS
electrical nerve stimulation

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18 to 30 years

You may not qualify if:

  • History of cardiovascular, neurologic or musculoskeletal disease
  • Taking medication at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Farzaneh Dehghan

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 28, 2012

Study Start

March 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

September 28, 2012

Record last verified: 2012-09