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Trial registered on ANZCTR
Registration number
ACTRN12610001026011
Ethics application status
Approved
Date submitted
19/11/2010
Date registered
23/11/2010
Date last updated
23/11/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Musculoskeletal Approach for Patients with Symptoms of Pudendal Neuopathy: A Case Series
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Scientific title
A Musculoskeletal Approach For Patients Management In Patients with Symptoms of Pudendal Neuropathy: A Case Series
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Secondary ID [1]
253145
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Nil
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Universal Trial Number (UTN)
Nil
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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:
Pudendal Neuralgia
258685
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Condition category
Condition code
Musculoskeletal
258829
258829
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
(a) 1. Mobilisation Techniques - A manual technique to mobilise/stretch the sacro-iliac joint applied by therapist.
2. Posture Awareness - the patient is instructed how to maintain the correct lumbar curvature posture while sitting at PC, driving etc.
3. Exercise - the patient is instructed by the therapist to perform 5 exercises designed to gain mobility of the sacro-iliac joint and to gain strength of the muscles which control the joint.
b) The intervention is administered until symptoms are reduced (or not). The average number of treatments is four interventions. Generally those will be administered twice a week for as many weeks as necessary.
c) The longest duration of treatment of any particular patient was three months - the minimum was one session. The duration of each intervention session was an hour.
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Intervention code [1]
257643
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Treatment: Other
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Intervention code [2]
257644
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Rehabilitation
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Comparator / control treatment
None (Cohort Study)
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Pain Intensity - self reporting with questionnaire
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Assessment method [1]
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Timepoint [1]
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Time Point - at end of treatment
- three months after treatment
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Secondary outcome [1]
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Sexual Dysfunction - self reporting questionnair
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Assessment method [1]
266389
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Timepoint [1]
266389
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Time Point - At Baseline
- Three months after treatment
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Eligibility
Key inclusion criteria
The signs, symptoms and history must fulfill the criteria for the definition of Pudendal Neuralgia
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Minimum age
No limit
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Urological diagnosis - such as prostadynia. It means anybody with a urological diagnosis would be excluded. For instance, prostadynia could be aurological diagnosis - but pain in the prostate area could be caused by pudendal neuralgia.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Completed
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Date of first participant enrolment
Anticipated
30/05/2008
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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
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Peter Dornan
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Address [1]
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13 Morley Street
Toowong QLD 4066
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Peter Dornan
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Address
13 Morley Street
Toowong QLD 4066
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Country
Australia
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Secondary sponsor category [1]
257289
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None
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Name [1]
257289
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Address [1]
257289
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Country [1]
257289
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Other collaborator category [1]
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University
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Name [1]
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University of Queensland
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Address [1]
251670
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St Lucia QLD 4072
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Country [1]
251670
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Michel Coppieters
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Address [2]
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University of Queensland
St Lucia QLD 4072
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Country [2]
251671
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Institutional Ethics Committee
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Ethics committee address [1]
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Institutional Ethics Committee
University of Queensland
St Lucia QLD 4072
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
260092
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Approval date [1]
260092
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Ethics approval number [1]
260092
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2008000007
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Summary
Brief summary
Selected patients with signs of pudendal neuralia and low back pain treated with physiotherapy consisting of mobilisation and exercises directed to the lumbar pelvic region.
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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
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Address
31934
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Country
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Phone
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Fax
31934
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Email
31934
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Contact person for public queries
Name
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Peter Dornan
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Address
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13 Morley Street
Toowong QLD 4066
Brisbane
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Country
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Australia
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Phone
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+61 7 3371 9155
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Fax
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+ 61 7 38710301
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Email
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[email protected]
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Contact person for scientific queries
Name
6109
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as above
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Address
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as above
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Country
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Australia
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Phone
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+61 7 33719155
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Fax
6109
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Email
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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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