Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000316101
Ethics application status
Approved
Date submitted
13/02/2019
Date registered
28/02/2019
Date last updated
1/07/2021
Date data sharing statement initially provided
28/02/2019
Date results provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does group physiotherapy improve outcomes for women with chronic pelvic pain?
Scientific title
Effect of physiotherapy-led group therapy on pain reporting and quality of life in women with chronic pelvic pain
Secondary ID [1] 297383 0
Nil known
Universal Trial Number (UTN)
U1111-1228-4810
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pelvic Pain 311535 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310172 310172 0 0
Physiotherapy
Musculoskeletal 310277 310277 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to determine if health or economic outcomes are improved when women with chronic pelvic pain have group education sessions included in care plans.
Participants with chronic pelvic pain referred to Physiotherapy will be quasi-randomised to one of three arms: 1) suite of scheduled individual consultations over 14 weeks (current/"usual" practice), 2) an introductory group education session attendance followed by a suite of scheduled individual consultations over 14 weeks and 3) an introductory group education session followed by weekly group therapy sessions (8 week program) and a suite of scheduled individual consultations over 14 weeks. Physiotherapy led group sessions will provide education about chronic pain, introduce relevant therapeutic concepts, promote treatment adherence and maintain motivation through regular contact and message reinforcement, and a consumer focus group will provide input to group session content/format. All treatment arms will be provided by Physiotherapists with post graduate qualifications in Women's Health Physiotherapy and a minimum 5 years clinical experience, and all intervention will occur at the Women's and Children's Hospital (Women's Physiotherapy department).
Treatment arm 1: Participants will attend individual face to face consultations with a Physiotherapist, and will undergo comprehensive assessment (subjective, objective) and management. The schedule of consultations is designed to promote motivation and adherence through more regular contact/reinforcement of key messages early in the schedule - participants will attend a 1 hour session, and then 30 min review appointments at 2 weeks / 6 weeks / 10 weeks / 14 weeks. Participants will receive locally developed take home written resources (specific to chronic pelvic pain) and be directed to existing applications/online programs (eg mindfulness applications) to reinforce the care received face to face.
Treatment arm 2: Participants will attend a preliminary group education session (2 hour duration) which will introduce key pain science concepts and chronic pain management strategies, before attending individual consultations (per treatment arm 1).
Treatment arm 3: Participants will attend the preliminary group education session and individual consultations (per treatment arm 2) but will also attend an 8 week group therapy program (1 hour sessions). Each group therapy session will be lead by an experienced Physiotherapist and will include an exercise component as well as a short education topic related to chronic pain management from the multi-disciplinary team. Participants will receive a copy of the commercially available "Explain Pain workbook: Protectometer" (available via http://www.protectometer.com/products.html) to work through over the 8 week group therapy program.
Intervention code [1] 313639 0
Rehabilitation
Intervention code [2] 313722 0
Treatment: Other
Comparator / control treatment
The control group is treatment arm 1 - "usual care"
Participants attend a suite of scheduled face to face individual consultations with an experienced Physiotherapist (with post graduate qualifications in Women's Health Physiotherapy and min. 5 years clinical experience). Appointments are scheduled to maximise early motivation and promote adherence - initial 1 hour appointment, and then 30 min review appointments at 2 weeks / 6 weeks / 10 weeks / 14 weeks. All appointments occur at the Women's and Children's Hospital, Women's Physiotherapy department.
Control group
Active

Outcomes
Primary outcome [1] 319057 0
Change in self reported pain score using NRS
Timepoint [1] 319057 0
Pre-intervention and post-intervention (week 14)
Primary outcome [2] 319058 0
Change in Pelvic Pain Impact Questionnaire (PPIQ) score
Timepoint [2] 319058 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [1] 366851 0
Change in self reported sense of progress using the Patient Global Impression of Improvement Scale,
Timepoint [1] 366851 0
At the 3rd individual consultation for all participants (week 6)
Secondary outcome [2] 366852 0
Change in absenteeism from study or work (self reported via the locally developed Intake and Discharge Questionnaire)
Timepoint [2] 366852 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [3] 366853 0
Change in medication use (self reported via the locally developed Intake and Discharge Questionnaire)
Timepoint [3] 366853 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [4] 366854 0
Participants' understanding of their condition and its management (self reported), as well as overall satisfaction with the care received, obtained via composite/single survey (series of 5-point Likert scale questions (strongly agree to strongly disagree) and open-ended questions for free-text answers)
Timepoint [4] 366854 0
Post-intervention (week 14)
Secondary outcome [5] 366855 0
Change in pain science knowledge using the Revised Neurophysiology of Pain Questionnaire (R-NPQ)
Timepoint [5] 366855 0
Immediately prior to group education and immediately post-group education for treatment arms 2 and 3
Secondary outcome [6] 366856 0
Change in physical activity engagement using the short version of the International Physical Activity Questionnaire (SIMPAQ),
Timepoint [6] 366856 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [7] 366857 0
Change in patient confidence to complete daily activities with their pain using the validated Patient Self Efficacy Questionnaire (PSEQ)
Timepoint [7] 366857 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [8] 366858 0
Change in patient emotional states relating to depression, anxiety and stress using the short form of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [8] 366858 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [9] 366859 0
Change in patient tendency to catastrophise their pain experience using the Pain Catastrophising Scale (PCS)
Timepoint [9] 366859 0
Pre-intervention and post-intervention (week 14)
Secondary outcome [10] 366860 0
Monitoring dropout and completion of physiotherapy treatment rates (plus an adverse events log) via Excel spreadsheet. It is possible that any pre-existing mental health symptoms may be exacerbated during assessment and management of chronic pain, due to the potentially sensitive nature of information disclosed, and this would be considered an adverse event.
Timepoint [10] 366860 0
Participant drop out will be monitored throughout the study as participants may elect to drop out at any time. Completion of Physiotherapy program rates will be calculated at the conclusion of the study (approx 20 weeks after final participant is randomised)
Secondary outcome [11] 366861 0
Time to discharge from WCH after treatment (access to hospital resources 6 months post program),
Timepoint [11] 366861 0
6 months post-intervention completion
Secondary outcome [12] 366862 0
Locally developed survey for those who decline/drop out to evaluate barriers to treatment commencement/ continuance
Timepoint [12] 366862 0
Drop out / non attendance will be monitored throughout the study and survey completed (written or via phone) when participant declines further participation.
Secondary outcome [13] 366867 0
Clinician perspectives regarding their level of understanding and use of chronic pain management strategies pre- and post-implementation of the intervention arms, as well overall satisfaction with the therapy arms provided, via semi-structured interview
Timepoint [13] 366867 0
Pre- and post-study

Eligibility
Key inclusion criteria
Pelvic pain that has been present for 6 months or more that has been medically investigated, with or without confirmed or suspected endometriosis
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) women from non-English speaking backgrounds requiring interpreting assistance,
b) women with known intellectual disability,
c) women who have previously accessed Physiotherapy intervention for CPP,
d) women with known presence of active, major mental disorder (e.g. psychotic disorder, clear suicide risk) and/or significant mental health symptoms precluding group participation,
e) women with an acute physical condition or illness exists which is currently being treated in a manner which would preclude adequate participation in the program,
f) women who have not had the source of their persistent pain adequately investigated medically.

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)
Women referred to the physiotherapy department for the treatment of CPP will be phoned and asked if they are interested in receiving information on the trial. If so, the trial will be discussed and a short series of screening questions will be completed to ensure suitability for trial inclusion. Purposive sampling will be used to allocate to treatment arm 3, given the potentially onerous time commitment required to complete the treatment arm. Where a participant declines treatment arm 3 but still wishes to participate in the study, they will be randomly allocated to either treatment arm 1 or 2 using allocation by sequentially numbered sealed opaque envelopes containing numbers representative of the 2 therapy arms. The envelopes will put together in a random way by a co-investigator (LH) uninvolved in the allocation process. A participant information sheet and informed consent form will be sent to them and on receipt of signed informed consent form, the co-chief investigator (TB) will open the next sequential envelope and allocate the participant to that arm of the trial. Block randomisation will be used to ensure a spread of women with/without confirmed/suspected endometriosis as well as an equal spread of women aged </> 25 years across treatment arm 1 and 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via random placement of envelopes by co-investigator (LH) uninvolved in allocation process - on receipt of signed written consent form, project coordinator will take the next envelope in sequence for treatment arm allocation (arms 1 and 2)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a randomised controlled trial (treatment arms 1 and 2) with the primary outcome NRS VAS (numerical rating scale visual analogue scale) assumed to follow normal distribution. A power calculation was based on a mean VAS of 58 with a standard deviation of 21 in a group of women with pelvic pain and endometriosis (Gerlinger et al., 2012). A sample size of n = 22 in each group is required for a two sample non-inferiority trial with a non-inferiority margin = 1.5, sd = 2, alpha = 0.05 and power = 0.80. Assuming a dropout rate of 25%, we will need to randomise 30 subjects to each group. ANCOVA will be used to compare post treatment VAS NRS between groups, adjusting for baseline VAS NRS, age, presence/absence of confirmed endometriosis and use of pain medication during study.
Quantitative analysis of pain assessment/impact scores, absenteeism and physical activity engagement will be undertaken.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
5/06/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
5/11/2020
Date of last data collection
Anticipated
30/10/2020
Actual
19/03/2021
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301953 0
Charities/Societies/Foundations
Name [1] 301953 0
Women's and Children's Hospital Foundation
Country [1] 301953 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 301710 0
None
Name [1] 301710 0
Address [1] 301710 0
Country [1] 301710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302635 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 302635 0
Ethics committee country [1] 302635 0
Australia
Date submitted for ethics approval [1] 302635 0
13/02/2019
Approval date [1] 302635 0
30/04/2019
Ethics approval number [1] 302635 0

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

Contacts
Principal investigator
Name 90890 0
Mrs Tara Beaumont
Address 90890 0
c/- Women's Health Physiotherapy
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 90890 0
Australia
Phone 90890 0
+61 0881617579
Fax 90890 0
Email 90890 0
[email protected]
Contact person for public queries
Name 90891 0
Tara Beaumont
Address 90891 0
c/- Women's Health Physiotherapy
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 90891 0
Australia
Phone 90891 0
+61 0881617579
Fax 90891 0
Email 90891 0
[email protected]
Contact person for scientific queries
Name 90892 0
Tara Beaumont
Address 90892 0
c/- Women's Health Physiotherapy
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 90892 0
Australia
Phone 90892 0
+61 0881617579
Fax 90892 0
Email 90892 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
There is no requirement to share individual participant data - de-identified data will be used for statistical analysis and reporting


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.