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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
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Scientific title
pain and quality of life in women diagnosed with endometriosis and treated with acupunture
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Universal Trial Number (UTN)
U1111-1114-5390
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Women with endometriosis
257043
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Condition category
Condition code
Alternative and Complementary Medicine
257203
257203
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0
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Other alternative and complementary medicine
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Renal and Urogenital
257204
257204
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
256220
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Treatment: Other
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Comparator / control treatment
no treatment
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Control group
Active
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Outcomes
Primary outcome [1]
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pain - visual analogue scale
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Assessment method [1]
258097
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Timepoint [1]
258097
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at baseline and after 6 weeks of treatment
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Primary outcome [2]
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Quality of life measured with the Brazilian version of the Endometriosis Health Profile Questionnaire - EHP-30
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Assessment method [2]
258098
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Timepoint [2]
258098
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at baseline and after 6 weeks of treatment
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Secondary outcome [1]
263700
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Nil
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Assessment method [1]
263700
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Timepoint [1]
263700
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Nil
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Eligibility
Key inclusion criteria
At least 18 years of age and to have a diagnosis of endometriosis for at least one year
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
To have been submitted to surgery of the pelvic area in the past 6 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/03/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2560
0
Brazil
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State/province [1]
2560
0
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Funding & Sponsors
Funding source category [1]
256721
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Self funded/Unfunded
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Name [1]
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Nill
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Address [1]
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Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
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Country [1]
256721
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Brazil
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Primary sponsor type
University
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Name
Universidade do Estado de Santa Catarina
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Address
Av. Madre Benvenuta, 2007 - Itacorubi - 88.035-001 - Florianopolis - SC
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Country
Brazil
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Secondary sponsor category [1]
256005
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Individual
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Name [1]
256005
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Fabiana Flores Sperandio
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Address [1]
256005
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Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
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Country [1]
256005
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Brazil
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Other collaborator category [1]
1172
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Individual
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Name [1]
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Marcos de Noronha
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Address [1]
1172
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Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
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Country [1]
1172
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Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258729
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Comite de Etica em Pesquisa em Seres Humanos da UDESC (Research Ethics Committee in Humans - UDESC)
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Ethics committee address [1]
258729
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Av. Madre Benvenuta, 2007 - Itacorubi - 88.035-001 - Florianopolis - SC
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Ethics committee country [1]
258729
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Brazil
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Date submitted for ethics approval [1]
258729
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Approval date [1]
258729
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Ethics approval number [1]
258729
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
30987
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Address
30987
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Country
30987
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Phone
30987
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Fax
30987
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Email
30987
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Contact person for public queries
Name
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Daniela Pacheco dos Santos
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Address
14234
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Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
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Country
14234
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Brazil
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Phone
14234
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+55 48 32481812
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Fax
14234
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Email
14234
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[email protected]
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Contact person for scientific queries
Name
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Marcos de Noronha
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Address
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Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
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Country
5162
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Brazil
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Phone
5162
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+55 48 32481812
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Fax
5162
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Email
5162
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[email protected]
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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.
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