Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001813279
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
7/11/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
PIPPI (Practical Interdisciplinary Pelvic Pain Intervention)
Development and delivery of a specialised Interdisciplinary Pain Management Group Program for women with Chronic Pelvic Pain.
Scientific title
PIPPI (Practical Interdisciplinary Pelvic Pain Intervention)
Development and delivery of a specialised Interdisciplinary Pain Management Group Program for women with Chronic Pelvic Pain.
Secondary ID [1] 295623 0
nil
Universal Trial Number (UTN)
U1111-1217-8342
Trial acronym
PIPPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pelvic Pain (Female) 308951 0
Condition category
Condition code
Reproductive Health and Childbirth 307848 307848 0 0
Other reproductive health and childbirth disorders
Anaesthesiology 307849 307849 0 0
Pain management
Renal and Urogenital 308915 308915 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Programme development stage
An audit of women attending the Christchurch Women’s Hospital Gynaecology Outpatients was undertaken to identify the current unmet needs in this population. An interdisciplinary team of clinicians with special interest in Chronic Pelvic Pain (CPP) was identified from the current Pain Management and Women’s Health services.
Additional skills and knowledge was gained by a variety of CPD activities. Existing international pelvic pain PMPs (Pain Management Programme) were contacted and information gathered via email contact, and by site visits.
The PIPPI PMP modules were developed collaboratively by the interdisciplinary team, covering all aspects of self-management as delivered within the current PMPs and incorporating themes which are specific to CPP. Joint planning sessions ensured that key themes and consistent messages are continued throughout the program.

Programme delivery stage
Following international guidelines which recommend a medium intensity group program to contain 8-12 participants, and provide 24-60 hours over 6-8 weeks from two clinicians per module.
We aim to recruit up to 12 women per group. The intervention will be 24 hours of group program- 4 hours, once a week for 6 weeks.
Four consecutive groups will be completed during this pilot programme, over a six-month period.
The intervention will be delivered to the group by a team of clinicians, including a doctor, pain management psychologist, dietician, pain management physiotherapist, women’s health physiotherapist, and pain management nurse. The sessions will be face to face delivery in small based in a meeting room at a hospital, via interactive workshops. Each module will be 45minutes duration, covering five topics each week.
The content will be manualised – for both clinician and participants, in order to maintain consistency of topic delivery.
‘Homework’ will be set for participants to complete between weekly sessions, for example a food diary to complete, or relaxation exercises to practice. Women will be asked to attend all six weeks of the programme, and attendance monitored by the clinicians delivering the modules. Absence from more than one week may lead to removal from the programme (this is outlined in the participant information and consent information).
Modules will be grounded in a cognitive behavioural model and include: Pain Neuroscience education (both didactic teaching and small group exercises); gentle graded supervised group exercise classes; relaxation, sleep and stress management; communication and problems solving; and dietary advice.
Self-complete paper based questionnaires will be administered at the commencement and end of the program, and for follow up at 3, 6 and 12 months.
Intervention code [1] 301927 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307820 0
As pain is a multidimensional and complex phenomenon, and by definition has both sensory and emotional components, unidimensional outcome measures such as simple numeric rating scales are not appropriate. Pain intensity has also been shown to be a poor predictor of future disability and quality of life.
The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations (IMMPACT) recommends that outcomes are assessed across six core outcome domains.

Outcomes will therefore be determined via clinically important changes in validated tools which cover these domains. Self-complete paper based questionnaires will be used,
Benchmarking comparisons with equivalent (or as equivalent as possible) pain management programs will also be undertaken.

1)The Brief Pain Inventory (BPI)
Timepoint [1] 307820 0
Commencement and end of the programme, and at 3, 6 and 12 months after completion of the programme.
Primary outcome [2] 307883 0
Depression, Anxiety and Stress Scale (DASS)
Timepoint [2] 307883 0
Commencement, and end of the programme, and at 3, 6 and 12 months after completion of the programme.
Primary outcome [3] 307884 0
Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [3] 307884 0
Commencement and end of the programme, and at 3, 6 and 12 months after completion of the programme.
Secondary outcome [1] 353053 0
PRIMARY OUTCOME 4 Pain Catastrophising Scale (PCS)
Timepoint [1] 353053 0
Commencement and end of the programme, and at 3, 6 and 12 months after completion of the programme.
Secondary outcome [2] 353217 0
PRIMARY OUTCOME 5 Multidimensional Sexuality Questionnaire (MSQ)
Timepoint [2] 353217 0
Commencement and end of the programme, and at 3, 6 and 12 months after completion of the programme.
Secondary outcome [3] 353218 0
Participant global impression of change
Timepoint [3] 353218 0
Commencement and end of the programme, and at 3, 6 and 12 months after completion of the programme.
Secondary outcome [4] 353219 0
Free text (written) participant feedback of satisfaction with the program will also be sought on the end of programme questionnaire.
Timepoint [4] 353219 0
End of programme (ie at the end of the 6 week intervention) questionnaire.

Eligibility
Key inclusion criteria
• Female
• Over age 18
• Able to give informed consent
• Abdomino-pelvic pain >6 months duration
• Accepting of the model of Pain Self-Management via group treatment

• Psychometric scores within range defined for "medium intensity" group program by the NSW Agency for Clinical Innovation:
Pain intensity: 5-8 on Brief Pain Inventory- intensity
Pain interference: 5-8 on BPI - interference
Depression: 14-20 on depression scale DASS
Pain self-efficacy: 20-35 on PSEQ
Catastrophising: 20-30 on PCS
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to give informed consent
• Poor literacy or English language (e.g. unable to understand information session content)
• Significant current mental health condition
• Current opioid use over 50mg OMED
• Awaiting acute surgical intervention
• Un-investigated "red flags" for serious disease
• Unable to safely participate in group activity and exercise
• Current or past cancer (excluding non-melanoma skin cancer)
• Currently pregnant
• Previous Pain self-management program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2018
Actual
1/04/2019
Date of last participant enrolment
Anticipated
4/09/2019
Actual
4/09/2019
Date of last data collection
Anticipated
1/11/2020
Actual
1/11/2020
Sample size
Target
48
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 20943 0
New Zealand
State/province [1] 20943 0

Funding & Sponsors
Funding source category [1] 300202 0
University
Name [1] 300202 0
University of Otago
Country [1] 300202 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
2 Riccarton Ave,
Christchurch
8011
Country
New Zealand
Secondary sponsor category [1] 300547 0
None
Name [1] 300547 0
Address [1] 300547 0
Country [1] 300547 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301028 0
Southern Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 301028 0
Ethics committee country [1] 301028 0
New Zealand
Date submitted for ethics approval [1] 301028 0
09/11/2018
Approval date [1] 301028 0
14/01/2019
Ethics approval number [1] 301028 0

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

Contacts
Principal investigator
Name 85642 0
Dr Karen Joseph
Address 85642 0
Christchurch DHB/University of Otago
Christchurch Hospital
2 Riccarton Ave
Christchurch
8011
Country 85642 0
New Zealand
Phone 85642 0
+64 33644699
Fax 85642 0
Email 85642 0
pippi@cdhb.health.nz
Contact person for public queries
Name 85643 0
Karen Joseph
Address 85643 0
Christchurch Hospital
2 Riccarton Ave
Christchurch
8011
Country 85643 0
New Zealand
Phone 85643 0
+64 33644699
Fax 85643 0
Email 85643 0
pippi@cdhb.health.nz
Contact person for scientific queries
Name 85644 0
Karen Joseph
Address 85644 0
Christchurch Hospital
2 Riccarton Ave
Christchurch
8011
Country 85644 0
New Zealand
Phone 85644 0
+64 33644699
Fax 85644 0
Email 85644 0
pippi@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the pilot and developmental nature of this study


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.