Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000278033
Ethics application status
Approved
Date submitted
29/03/2010
Date registered
7/04/2010
Date last updated
7/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of acupunture in women with endometriosis
Scientific title
pain and quality of life in women diagnosed with endometriosis and treated with acupunture
Universal Trial Number (UTN)
U1111-1114-5390
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with endometriosis 257043 0
Condition category
Condition code
Alternative and Complementary Medicine 257203 257203 0 0
Other alternative and complementary medicine
Renal and Urogenital 257204 257204 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupunture will be applied in 27 diferent points of the body for 6 weeks, twice a week. The acupunture needles will be kept in place for 20 minutes for each session. Considering that first the needles will be applied on the frontal region of the body, then on the posterior region of the body. Each session will take approximately one hour.
Intervention code [1] 256220 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 258097 0
pain - visual analogue scale
Timepoint [1] 258097 0
at baseline and after 6 weeks of treatment
Primary outcome [2] 258098 0
Quality of life measured with the Brazilian version of the Endometriosis Health Profile Questionnaire - EHP-30
Timepoint [2] 258098 0
at baseline and after 6 weeks of treatment
Secondary outcome [1] 263700 0
Nil
Timepoint [1] 263700 0
Nil

Eligibility
Key inclusion criteria
At least 18 years of age and to have a diagnosis of endometriosis for at least one year
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
To have been submitted to surgery of the pelvic area in the past 6 months

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)
Randomization will be performed by a researcher not involved in defining whether the participant is eligible for the study. Also, we will use sealed opaque envelopes to ensure concealment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2560 0
Brazil
State/province [1] 2560 0

Funding & Sponsors
Funding source category [1] 256721 0
Self funded/Unfunded
Name [1] 256721 0
Nill
Country [1] 256721 0
Brazil
Primary sponsor type
University
Name
Universidade do Estado de Santa Catarina
Address
Av. Madre Benvenuta, 2007 - Itacorubi - 88.035-001 - Florianopolis - SC
Country
Brazil
Secondary sponsor category [1] 256005 0
Individual
Name [1] 256005 0
Fabiana Flores Sperandio
Address [1] 256005 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [1] 256005 0
Brazil
Other collaborator category [1] 1172 0
Individual
Name [1] 1172 0
Marcos de Noronha
Address [1] 1172 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [1] 1172 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258729 0
Comite de Etica em Pesquisa em Seres Humanos da UDESC (Research Ethics Committee in Humans - UDESC)
Ethics committee address [1] 258729 0
Av. Madre Benvenuta, 2007 - Itacorubi - 88.035-001 - Florianopolis - SC
Ethics committee country [1] 258729 0
Brazil
Date submitted for ethics approval [1] 258729 0
Approval date [1] 258729 0
Ethics approval number [1] 258729 0

Summary
Brief summary
The purpose of the study is to evaluate whether acupunture can decrease the pain and improve the quality of life of women with endometriosis. It is possible that acupunture will significantly decrease the pain and improve the quality of life of those women
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30987 0
Address 30987 0
Country 30987 0
Phone 30987 0
Fax 30987 0
Email 30987 0
Contact person for public queries
Name 14234 0
Daniela Pacheco dos Santos
Address 14234 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 14234 0
Brazil
Phone 14234 0
+55 48 32481812
Fax 14234 0
Email 14234 0
danisantos82@yahoo.com.br
Contact person for scientific queries
Name 5162 0
Marcos de Noronha
Address 5162 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 5162 0
Brazil
Phone 5162 0
+55 48 32481812
Fax 5162 0
Email 5162 0
d2man@udesc.br

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.