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Trial registered on ANZCTR
Registration number
ACTRN12619001611112
Ethics application status
Approved
Date submitted
31/10/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Hydrotherapy for women with persistent pelvic pain
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Scientific title
Hydrotherapy in the management of persistent pelvic pain: A pilot randomised controlled trial
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Secondary ID [1]
299672
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Nil known
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Universal Trial Number (UTN)
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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:
Persistent pelvic pain
315017
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Endometriosis
315034
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Condition category
Condition code
Reproductive Health and Childbirth
313350
313350
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a prospective, single blinded pilot randomised controlled trial with concealed allocation, blinded assessors and intention to treat analysis. In addition to usual care, participants allocated to the intervention group will be invited to attend a group-based, weekly hydrotherapy class for 8 weeks supervised by a Physiotherapist. All hydrotherapy sessions will be a maximum of one hour in duration and will take place within the Physiotherapy Department. The structure of the hydrotherapy sessions will include a warm up, targeted exercises and cool down. Exercises will include but are not limited to walking in water, pelvic floor exercises, pelvic stretches and relaxation, deep water walking, pendular exercises and sea weeding. Session attendance and adherence to the exercises will be monitored by an exercise chart kept in a folder with the Physiotherapist providing the hydrotherapy intervention. This is a different Physiotherapist to that providing usual care.
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Intervention code [1]
315935
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Treatment: Other
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Comparator / control treatment
The control group will be provided with usual care interventions for those patients referred to the Royal Brisbane and Women's Hospital Physiotherapy Department for persistent pelvic pain due to endometriosis. Usual care is a multimodal approach whereby treatment interventions are based on a comprehensive assessment undertaken at the time of the patient’s initial appointment with the service. A broad overview of the interventions that may be undertaken during a patient’s episode of care with the service include:
• Pelvic Floor relaxation exercises
• Visualisation techniques
• Deep Tissue Release of the Pelvic Floor
• Contract – relax techniques
• Avoidance of maximal pelvic floor exercises
• Pressure Biofeedback
• EMG Biofeedback
• Dry needling
• General exercise regimes
• Dietary advice specific to Physiotherapy management of Persistent Pelvic Pain
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain will be assessed by Visual Analogue Scale (VAS).
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Assessment method [1]
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Timepoint [1]
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This measure will be collected by a blinded assessor at baseline and the 8-week follow-up
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Primary outcome [2]
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Pelvic pain impact
This outcome will be measured using the Pelvic Pain Impact Questionnaire (PPIQ), an instrument used to measure the impact of pelvic pain on quality of life.
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Assessment method [2]
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Timepoint [2]
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Baseline and at the 8-week follow-up
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Primary outcome [3]
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Pelvic floor function
This outcome will be measured using the Australian Pelvic Floor Questionnaire (APFQ) which is a validated instrument used to record pelvic floor symptoms, in addition to bladder, bowel and sexual function, pelvic organ prolapse and condition specific quality of life
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Assessment method [3]
321999
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Timepoint [3]
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Baseline and at the 8-week follow-up
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Secondary outcome [1]
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Generic health status using the EQ-5D-5L
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Assessment method [1]
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Timepoint [1]
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Baseline and 8 week follow up
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Secondary outcome [2]
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Attendance rates will be assessed by an attendance log kept by the Physiotherapist providing the hydrotherapy.
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Assessment method [2]
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Timepoint [2]
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Time point will be at completion of the study. It is anticipated that the trial will take 2 years to complete.
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Secondary outcome [3]
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Cost differentials will be assessed by calculating the cost differential between resources used for providing usual care and attendance at group hydrotherapy sessions. Physiotherapy WAUs will be used to calculate labour costs. A record of appointments will come from hospital medical records and hydrotherapy attendance logs. A log will be kept of the parking costs reimbursed to patients.
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Assessment method [3]
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Timepoint [3]
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Time point will be at completion of the study.
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Secondary outcome [4]
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Acceptability of the programme will be determined using a purpose built questionnaire related to satisfaction with components relevant to the programme. A subset of questions will be identical for both intervention and control groups, with remaining questions relevant to the intervention received.
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Assessment method [4]
377143
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Timepoint [4]
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8 weeks post baseline
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Eligibility
Key inclusion criteria
Inclusion criteria include:
- female participants
- minimum age 18 years (at the time of study recruitment)
- have a formal diagnosis of endometriosis determined by a laparoscopic procedure undertaken at least 6 months prior to study recruitment
- referral to the Royal Brisbane and Women's Hospital Physiotherapy Department for management of their persistent pelvic pain condition.
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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
Exclusion criteria include:
• Conditions that contra-indicate hydrotherapy (open wounds, active infection, heat sensitive condition, fear of water)
• Physiotherapy treatment for the same condition within the last 6 months
• Severe psychiatric history where it is judged that safety during hydrotherapy may be compromised
• Non-English speaking background where an accredited interpreter is required to be present
• Concomitant diagnosis of Fibromyalgia
• Unable to commit to the 8-week intervention period
• Post-menopausal (as defined by absence of menses for 12 months without a pathological cause. The average age at which this occurs is 51.4 years)
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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)
Allocation will be by sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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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
Analysis would initially consist of a baseline comparison for demographic and clinical variables. Due to the small sample size, group-by-time interactions for the primary outcomes of interest (i.e. Pain VAS, PPIQ and EQ-5D-5L) will be analysed using non-parametric statistics (e.g. Friedman test), while within-group differences over time will be analysed using Wilcoxon signed-rank tests. Cost and feasibility analyses will be assessed against usual care alone in relation to clinician time costings, waiting list impact and expense data collected.
Patient-related experience and satisfaction surveys will be presented descriptively where identical items between the two cohorts will be compared using Mann-Whitney U tests.
Service utilisation between the intervention groups will be compared descriptively. The net financial position of each intervention group will be calculated based upon the total estimated revenue (attracted through attended appointments) less total estimated costs (through direct labour and non-labour expenses) incurred during the intervention period.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/01/2020
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Actual
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Date of last participant enrolment
Anticipated
1/11/2021
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Actual
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Date of last data collection
Anticipated
24/01/2022
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
28362
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Royal Brisbane and Women's Hospital
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Address [1]
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Cnr Butterfield Street and Bowen Bridge Road
Herston, Brisbane, QLD 4029
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Royal Brisbane and Women's Hospital
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Address
Cnr Butterfield Street and Bowen Bridge Road
Herston, Brisbane, QLD 4029
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
304377
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304626
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Royal Brisbane and Women's Hospital Human Research Ethics Committee
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Ethics committee address [1]
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Lower Ground Floor, Dr James Mayne Building Herston, Qld, 4029
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/07/2019
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Approval date [1]
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03/09/2019
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Ethics approval number [1]
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HREC/2019/QRBW/54836
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Summary
Brief summary
The aim of this study is to investigate whether a course of water based exercises, in addition to usual Physiotherapy, improves symptoms and quality of life in patients with Persistent Pelvic Pain due to endometriosis, when compared to usual Physiotherapy alone. If women in this study gain relief from their symptoms, hydrotherapy may become another treatment option for this condition. The results of this research will be used to decide whether hydrotherapy is useful to help treat this condition and whether it can be provided by the RBWH Physiotherapy Department.
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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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Ms Cara Masterson
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Address
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Physiotherapy Department
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
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Country
97638
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Australia
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Phone
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+61 73646 8111
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Fax
97638
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+61736461665
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Email
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cara.masterson@health.qld.gov.au
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Contact person for public queries
Name
97639
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Cara Masterson
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Address
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Physiotherapy Department
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Bowen Bridge Road
Herston, QLD, 4029
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Country
97639
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Australia
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Phone
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+61 73646 8111
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Fax
97639
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+61736461665
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Email
97639
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cara.masterson@health.qld.gov.au
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Contact person for scientific queries
Name
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Cara Masterson
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Address
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Physiotherapy Department
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Bowen Bridge Road
Herston, QLD, 4029
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Country
97640
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Australia
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Phone
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+61 73646 8111
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Fax
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+61736461665
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Email
97640
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cara.masterson@health.qld.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5511
Informed consent form
PICF and consent form
378645-(Uploaded-31-10-2019-10-25-21)-Study-related document.pdf
5513
Ethical approval
RBWH HREC Ethical Approval letter
378645-(Uploaded-31-10-2019-10-26-42)-Study-related document.pdf
5514
Other
Form for Withdrawal of Participation
378645-(Uploaded-31-10-2019-10-27-36)-Study-related document.docx
5515
Other
Patient Experience and Satisfaction Survey - Contr...
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More Details
]
378645-(Uploaded-31-10-2019-11-19-12)-Study-related document.pdf
5585
Other
Patient Satisfaction Survey - Intervention
378645-(Uploaded-07-11-2019-11-09-19)-Study-related document.pdf
5733
Study protocol
Study protocol (including statistical analysis pla...
[
More Details
]
378645-(Uploaded-18-11-2019-13-30-28)-Study-related document.pdf
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.
Download to PDF