Trial Review

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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
Scientific title
Hydrotherapy in the management of persistent pelvic pain: A pilot randomised controlled trial
Secondary ID [1] 299672 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent pelvic pain 315017 0
Endometriosis 315034 0
Condition category
Condition code
Reproductive Health and Childbirth 313350 313350 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315935 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 321826 0
Pain will be assessed by Visual Analogue Scale (VAS).
Timepoint [1] 321826 0
This measure will be collected by a blinded assessor at baseline and the 8-week follow-up
Primary outcome [2] 321846 0
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.
Timepoint [2] 321846 0
Baseline and at the 8-week follow-up
Primary outcome [3] 321999 0
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
Timepoint [3] 321999 0
Baseline and at the 8-week follow-up
Secondary outcome [1] 376371 0
Generic health status using the EQ-5D-5L
Timepoint [1] 376371 0
Baseline and 8 week follow up
Secondary outcome [2] 376447 0
Attendance rates will be assessed by an attendance log kept by the Physiotherapist providing the hydrotherapy.
Timepoint [2] 376447 0
Time point will be at completion of the study. It is anticipated that the trial will take 2 years to complete.
Secondary outcome [3] 376448 0
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.
Timepoint [3] 376448 0
Time point will be at completion of the study.
Secondary outcome [4] 377143 0
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.
Timepoint [4] 377143 0
8 weeks post baseline

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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)

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)
Allocation will be by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
24/01/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15066 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 28362 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 304146 0
Hospital
Name [1] 304146 0
Royal Brisbane and Women's Hospital
Country [1] 304146 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Cnr Butterfield Street and Bowen Bridge Road
Herston, Brisbane, QLD 4029
Country
Australia
Secondary sponsor category [1] 304377 0
None
Name [1] 304377 0
Address [1] 304377 0
Country [1] 304377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304626 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 304626 0
Ethics committee country [1] 304626 0
Australia
Date submitted for ethics approval [1] 304626 0
26/07/2019
Approval date [1] 304626 0
03/09/2019
Ethics approval number [1] 304626 0
HREC/2019/QRBW/54836

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97638 0
Ms Cara Masterson
Address 97638 0
Physiotherapy Department
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 97638 0
Australia
Phone 97638 0
+61 73646 8111
Fax 97638 0
+61736461665
Email 97638 0
[email protected]
Contact person for public queries
Name 97639 0
Cara Masterson
Address 97639 0
Physiotherapy Department
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Bowen Bridge Road
Herston, QLD, 4029
Country 97639 0
Australia
Phone 97639 0
+61 73646 8111
Fax 97639 0
+61736461665
Email 97639 0
[email protected]
Contact person for scientific queries
Name 97640 0
Cara Masterson
Address 97640 0
Physiotherapy Department
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Bowen Bridge Road
Herston, QLD, 4029
Country 97640 0
Australia
Phone 97640 0
+61 73646 8111
Fax 97640 0
+61736461665
Email 97640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5511Informed consent form    PICF and consent form 378645-(Uploaded-31-10-2019-10-25-21)-Study-related document.pdf
5513Ethical approvalRBWH HREC Ethical Approval letter   378645-(Uploaded-31-10-2019-10-26-42)-Study-related document.pdf
5514Other    Form for Withdrawal of Participation 378645-(Uploaded-31-10-2019-10-27-36)-Study-related document.docx
5515Other    Patient Experience and Satisfaction Survey - Contr... [More Details] 378645-(Uploaded-31-10-2019-11-19-12)-Study-related document.pdf
5585Other    Patient Satisfaction Survey - Intervention 378645-(Uploaded-07-11-2019-11-09-19)-Study-related document.pdf
5733Study 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.