Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610001015033
Ethics application status
Approved
Date submitted
26/05/2010
Date registered
19/11/2010
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of carrier frequency of interferential current on pressure pain threshold and sensory discomfort
Scientific title
Effect of carrier frequency of interferential current on pressure pain threshold and sensory discomfort in healthy humans.
Secondary ID [1] 251864 0
None
Universal Trial Number (UTN)
U1111-1115-1410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure pain threshold 257463 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257611 257611 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of 5 treatment groups:
a) Carrier frequency set at 1 KHz
b) Carrier frequency set at 2 KHz
c) Carrier frequency set at 4 KHz
d) Carrier frequency set at 8 KHz
e) Carrier frequency set at 10 KHz
In all groups the amplitude-modulated frequency (AMF) will be set at 100 Hz. The duration of application will be 20 minutes and the treatment will be applied in a single session for each participant. The electrodes (50 x 90 mm) will be placed on anterior and lateral aspect of the forearm to stimulate the median nerve and the superficial radial nerve.
Pressure Pain Thresholds will be recorded from one point at the hand and another point at the forearm, before the treatment (baseline), 10 min and 20min after the beginning of the treatment, and 20 min after the end of the treatment.
Visual Analog Scale will be used to assess the discomfort during the electrical stimulation at 10 min and 20min after the beginning of the treatment.
Intervention code [1] 256552 0
Treatment: Devices
Comparator / control treatment
All the groups will be used as control itself.
Control group
Active

Outcomes
Primary outcome [1] 258521 0
Pressure pain thresholds will be assessed using a pressure algometer in 2 points:
a) 3 cm distal to the distal end of the anatomical snuff box in the midline of the belly of the first dorsal interosseous muscle;
b) on the anterior aspect of the forearm, 7.5 cm proximal to
the distal wrist crease.
Timepoint [1] 258521 0
Pressure pain thresholds will be recorded:
- before application of interferential current
- 10 and 20 minutes after the begginning of the treatment
- 20 minutes after the end of the treatment.
Secondary outcome [1] 264341 0
Sensory discomfort, assessed by the VAS.
Timepoint [1] 264341 0
At 10 and 20 minutes during interferential current application.

Eligibility
Key inclusion criteria
Healthy subjects, Interferential naïve.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy, cardiac pacemaker, nerve injury in upper limbs, infection, cancer, skin damage and skin allergies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited from the staff and students of the University of the City of Sao Paulo (UNICID).
Participants will be stratified by gender and randomization will be performed using the permuted block method. Sequentially numbered, opaque sealed envelopes (SNOSE) allocation concealment method will be used. The envelopes will be stored in a secure cabinet that only the allocation investigator had access to and will be opened immediately prior to intervention allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2010
Actual
21/06/2010
Date of last participant enrolment
Anticipated
Actual
10/08/2011
Date of last data collection
Anticipated
Actual
10/08/2011
Sample size
Target
150
Accrual to date
Final
150
Recruitment outside Australia
Country [1] 2670 0
Brazil
State/province [1] 2670 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257050 0
University
Name [1] 257050 0
University of the City of Sao Paulo (UNICID)
Country [1] 257050 0
Brazil
Funding source category [2] 258083 0
Government body
Name [2] 258083 0
CNPq
Country [2] 258083 0
Brazil
Primary sponsor type
Individual
Name
Richard Eloin Liebano
Address
Rua Barao do Bananal, 980, Apto 63
Vila Pompeia
Sao Paulo-SP
CEP: 05024-000
Country
Brazil
Secondary sponsor category [1] 256309 0
Individual
Name [1] 256309 0
Roberta Ceila Venancio
Address [1] 256309 0
Rua Mira Estrela 41 Casa 1
Parada Inglesa
Sao Paulo-SP
CEP: 02307-030
Country [1] 256309 0
Brazil
Secondary sponsor category [2] 257268 0
University
Name [2] 257268 0
University of the City of Sao Paulo
Address [2] 257268 0
Rua Cesario Galeno 448/475
Tatuape, Sao Paulo - SP.
CEP: 03071-000
Country [2] 257268 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304807 0
Comite de Etica UNICID
Ethics committee address [1] 304807 0
Rua Cesario Galeno, 448/475 Tatuape – Sso Paulo – SP CEP 03071-000
Ethics committee country [1] 304807 0
Brazil
Date submitted for ethics approval [1] 304807 0
27/04/2010
Approval date [1] 304807 0
17/05/2010
Ethics approval number [1] 304807 0
PP 13502652

Summary
Brief summary
The objective of the current study is to compare the effect of different carrier frequencies of interferential current on pressure pain threshold and sensorial comfort.
Our hypothesis is that higher frequencies will be less uncomfortable and there will not be differences on pressure pain thresholds between the carrier frequencies.
Trial website
Trial related presentations / publications
https://www.archives-pmr.org/article/S0003-9993(12)00881-7/fulltext
Public notes

Contacts
Principal investigator
Name 31221 0
Prof Richard Eloin Liebano
Address 31221 0
Rua Barao do Bananal, 980, Apto 63. Vila Pompeia, Sao Paulo-SP CEP: 05024-000
Country 31221 0
Brazil
Phone 31221 0
+5511966292780
Fax 31221 0
Email 31221 0
[email protected]
Contact person for public queries
Name 14468 0
Prof Richard Eloin Liebano
Address 14468 0
Rua Barao do Bananal, 980, Apto 63.
Vila Pompeia, Sao Paulo-SP
CEP: 05024-000
Country 14468 0
Brazil
Phone 14468 0
55-11-66292780
Fax 14468 0
Email 14468 0
[email protected]
Contact person for scientific queries
Name 5396 0
Prof Richard Eloin Liebano
Address 5396 0
Rua Barao do Bananal, 980, Apto 63.
Vila Pompeia, Sao Paulo-SP
CEP: 05024-000
Country 5396 0
Brazil
Phone 5396 0
55-11-66292780
Fax 5396 0
Email 5396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://www.archives-pmr.org/article/S0003-9993(12... [More Details] 335543-(Uploaded-18-11-2019-11-31-44)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.