Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000265077
Ethics application status
Not yet submitted
Date submitted
29/03/2010
Date registered
31/03/2010
Date last updated
31/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The sustained effects of Osteopathic Treatment on Primary Dysmennorhoea
Scientific title
In patients with primary dysmennorhoea, is sustained osteopathic treatment more beneficial than medication in reducing pain and medication usage?
Secondary ID [1] 1528 0
None
Universal Trial Number (UTN)
U1111-1114-5008
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmennorhoea 257003 0
Condition category
Condition code
Reproductive Health and Childbirth 257165 257165 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteopathic treatment. The osteopathic treatments are conducted at the Victoria University Teaching Clinic with consultations approximately 45 minutes in duration. Treatment will be administered twice per week during the fortnight before menstruation. Treatment will continue over two months (four treatment consultations in total) with the last two months being used to determine if there is a long term effect of osteopathic treatment.
Intervention code [1] 256182 0
Treatment: Other
Comparator / control treatment
allopathic medication. Patients will not be administered any medication. Patients will be instructed to continue the use of allopathic medication as they would normally.
Control group
Active

Outcomes
Primary outcome [1] 258050 0
Pain scales. We will use the Mankoski Pain Scale. This is a functional pain scale particularly concerned with period pain. Patients are asked to rate their level of pain on a scale of 0-10 (0= pain free, with 10 = unconcious due to the pain). Our patients will be required to suffer from Period pain of a level of 3 = annoying enough to be distracting in order to determine any effects of osteopathic treatment.
Timepoint [1] 258050 0
pre-commencement baseline, then monthly for four months
Secondary outcome [1] 263631 0
medication diary for medication usage
Timepoint [1] 263631 0
pre-commencement baseline, then monthly for four months

Eligibility
Key inclusion criteria
Patients suffering from primary dysmennorhoea with no pathological cause
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants suffering from secondary dysmennorhoea, outside age range, or pregnant

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 sought via advertising in university teaching clinic and email to staff and students of the university. We will use numbered containers for allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbers out of a hat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
use of pre-trial medication diaries to establish medication baseline
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256683 0
Self funded/Unfunded
Name [1] 256683 0
Country [1] 256683 0
Australia
Primary sponsor type
Individual
Name
Dr. Brian Nicholls
Address
Victoria University,
301 Flinders Lane,
Melbourne, Vic. 3000
Country
Australia
Secondary sponsor category [1] 256017 0
None
Name [1] 256017 0
Address [1] 256017 0
Country [1] 256017 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258730 0
Victoria University Human Research Ethics Commitee
Ethics committee address [1] 258730 0
Victoria University
Footscray Park Campus
Ballarat road
Footscray
VIC, 3011
Ethics committee country [1] 258730 0
Australia
Date submitted for ethics approval [1] 258730 0
11/02/2010
Approval date [1] 258730 0
Ethics approval number [1] 258730 0
HRETH 09/190

Summary
Brief summary
A randomised controlled intervention study investigating the effect of sustained osteopathic treatment on the pain levels and medication usage in primary dysmennorrhoea
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 30966 0
Address 30966 0
Country 30966 0
Phone 30966 0
Fax 30966 0
Email 30966 0
Contact person for public queries
Name 14213 0
Dr Brian Nicholls
Address 14213 0
Victoria University
Flinders Lane Campus
Level 4, 301 Flinders Lane
Melbourne
VIC 3000
Country 14213 0
Australia
Phone 14213 0
+61 3 99191150
Fax 14213 0
Email 14213 0
[email protected]
Contact person for scientific queries
Name 5141 0
Dr Brian Nicholls
Address 5141 0
Victoria University
Flinders Lane Campus
Level 4, 301 Flinders Lane
Melbourne
VIC 3000
Country 5141 0
Australia
Phone 5141 0
+61 3 99191150
Fax 5141 0
Email 5141 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.