NCT01950728

Brief Summary

The objective of this study is to compare the hypoalgesic effects of TENS, Interferential current and Aussie current in pressure pain threshold and sensory discomfort in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
4 years until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

September 23, 2013

Last Update Submit

January 23, 2018

Conditions

Healthy

Keywords

volunteers18 to 65 yearsMales and Females

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold

    Pressure Pain Threshold will be measured using a digital pressure algometer SOMEDIC type II. The applied force will be measured in Newton (N).

    Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation.

Secondary Outcomes (1)

  • Sensory Discomfort

    15 and 30 minutes after the beginning of electrical stimulation.

Study Arms (4)

Control group

NO INTERVENTION

This group will not receive electrical stimulation. Volunteers will rest during 30 minutes.

Interferential current group

ACTIVE COMPARATOR

Interferential current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.

Device: Interferential current

TENS Group

ACTIVE COMPARATOR

TENS will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.

Device: TENS

Aussie current group

ACTIVE COMPARATOR

Aussie current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.

Device: Aussie Current

Interventions

Interferential currentDEVICE

Interferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz.

Interferential current group
Aussie CurrentDEVICE

Aussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz.

Aussie current group
TENSDEVICE

TENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz.

TENS Group

Eligibility Criteria

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

You may qualify if:

  • health adults

You may not qualify if:

  • injury to nerves of the upper limbs, pain, pregnancy, chronic diseases, cardiac pacemaker, epilepsy, allergy to the electrode used, use of pain medication, skin lesions or lack of sensitivity in the areas of electrode placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPA Pompéia UNIP

São Paulo, 17580-970, Brazil

Location

Related Publications (1)

  • Rampazo da Silva EP, da Silva VR, Bernardes AS, Matuzawa FM, Liebano RE. Study protocol of hypoalgesic effects of low frequency and burst-modulated alternating currents on healthy individuals. Pain Manag. 2018 Mar;8(2):71-77. doi: 10.2217/pmt-2017-0058. Epub 2018 Feb 16.

    PMID: 29451431DERIVED

MeSH Terms

Interventions

Electric Stimulation TherapyTranscutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapy Student

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

September 25, 2017

Primary Completion

December 18, 2017

Study Completion

January 23, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

BR(1)