Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000466044
Ethics application status
Approved
Date submitted
5/06/2010
Date registered
8/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effect of transcutaneous electric nerve simulation (TENS) for the treatment of primary dysmenorrhea.
Scientific title
A randomised, double-blind, placebo controlled clinical trial of the effectiveness of high and low frequency transcutaneous electrical nerve stimulation (TENS) on pain intensity in primary dysmenorrhea.
Secondary ID [1] 251957 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhea 257524 0
Condition category
Condition code
Reproductive Health and Childbirth 257684 257684 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subjects will assigned randomly to one of 3 groups:
1) TENS High frequency, will receive conventional TENS of 100 Hz, pulse width of 100 microseconds;
2) TENS Low frequency, will receive TENS of 4 Hz, pulse width of 100 microseconds;
3) TENS Placebo.
The treatment will be performed in a single session, and the TENS will be applied for 30 minutes. Each subject will notified the investigator upon onset of her pain. The treatment will be administered when the subject notifies investigator that she is experiencing pain during a menstrual cycle or 3 days before the menstruation.The subjects will instructed to take no pain medication for at least six hours before treatment. Two electrodes will placed on the low back area (L3, L4), and the others two over suprapubic area.
Intervention code [1] 256620 0
Treatment: Devices
Comparator / control treatment
The TENS placebo, there was no perceptible sensation, because the TENS unit was switched on to display an active indicator light without any electrical stimulation. The placebo treatment will be applied for 30 minutes and he treatment will be performed in a single session. Two electrodes will placed
on the low back area (L3, L4), and the others two over suprapubic area.
Control group
Placebo

Outcomes
Primary outcome [1] 258588 0
Pain intensity will be assessed using numerical rating scale (NRS)
Timepoint [1] 258588 0
Assessment of pain intensity will be performed before the TENS, 30 minutes and 120 minutes later.
Secondary outcome [1] 264483 0
nil
Timepoint [1] 264483 0
nil

Eligibility
Key inclusion criteria
Women of reproductive age; women with moderate to severe primary dysmenorrhea; women affected by dysmenorrhea in >50% of their menstrual cycles.
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women with secondary dysmenorrhea; women with dysmenorrhea due to the presence of an intrauterine device; women with mild or infrequent dysmenorrhoea.

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)
The method in which allocation concealment was performed, i.e. the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed and it was done by central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table created by a computer software. Randomization occurred as each patient was registered in the study and prepared previously to data collection.
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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2685 0
Brazil
State/province [1] 2685 0
Petrolina/Pernambuco

Funding & Sponsors
Funding source category [1] 257108 0
University
Name [1] 257108 0
University of Pernambuco
Country [1] 257108 0
Brazil
Primary sponsor type
University
Name
University of Pernambuco
Address
BR 203 Km 2 s/n Vila Eduardo, Campus Universitario, zip code: 56300-000, Petrolina, Pernambuco.
Country
Brazil
Secondary sponsor category [1] 256370 0
None
Name [1] 256370 0
Address [1] 256370 0
Country [1] 256370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259149 0
Research Ethics Committee of the University of Pernambuco
Ethics committee address [1] 259149 0
Av. Agamenon Magalhaes s/n Santo Amaro, zipe code: 50100-010, Recife, Pernambuco.
Ethics committee country [1] 259149 0
Brazil
Date submitted for ethics approval [1] 259149 0
Approval date [1] 259149 0
02/02/2010
Ethics approval number [1] 259149 0
1/09/0259

Summary
Brief summary
This is a controlled, double-blind, randomized clinical study that compares three study groups; high-frequency TENS, low-frequency TENS and placebo TENS. The aim of this study will be to determine the effectiveness of high and low frequency transcutaneous electrical nerve stimulation when compared to placebo for treatment of primary dysmenorrhea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31264 0
Address 31264 0
Country 31264 0
Phone 31264 0
Fax 31264 0
Email 31264 0
Contact person for public queries
Name 14511 0
Ana Carolina Rodarti Pitangui
Address 14511 0
Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
Country 14511 0
Brazil
Phone 14511 0
+55 87 38666496
Fax 14511 0
Email 14511 0
[email protected]
Contact person for scientific queries
Name 5439 0
Ana Carolina Rodarti Pitangui
Address 5439 0
Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
Country 5439 0
Brazil
Phone 5439 0
+55 87 38666496
Fax 5439 0
Email 5439 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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