Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000142730
Ethics application status
Approved
Date submitted
12/01/2022
Date registered
27/01/2022
Date last updated
1/02/2023
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Social Groups for Pain - A randomised controlled trial of group social education, and group facilitation of meaningful social interaction in people with chronic pain.
Scientific title
Social Groups for Pain - A randomised controlled trial of group social education, and group facilitation of meaningful social interaction in people with chronic pain.
Secondary ID [1] 306194 0
RSS_2022_133
Secondary ID [2] 306195 0
ION80003456
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 324897 0
Social isolation 324898 0
Anxiety 324899 0
Depression 324900 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322334 322334 0 0
Other physical medicine / rehabilitation
Anaesthesiology 322425 322425 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a group intervention (4-6 participants). There are 5-6 2h sessions, on a weekly basis. In sessions 1 and 2 there is education in the importance of social connection and meaningful activity and then the exploration of personally meaningful social connection and activity. The remaining sessions are based around experimentation and engagement with these people and activities with identification of barriers and support to negotiate these challenges. There is also a session on the effect of music on mood modulation and how this can help to enable optimal behaviour in social situations.
The sessions will be conducted in person at a chronic pain clinic associated with a large teaching hospital in Brisbane, Australia.
Sessions will be conducted in person, however there is the option of telehealth (video) sessions if needed.
Attendance records will be kept for each session, including type of interaction (telehealth or in-person)
Intervention code [1] 322598 0
Lifestyle
Intervention code [2] 322599 0
Behaviour
Intervention code [3] 322600 0
Rehabilitation
Comparator / control treatment
Waitlist group. Participants will be randomised to either start immediately (treatment group) or wait for 12 weeks after the end of the treatment group (control group). During this time the control group will receive "usual treatment", which may include medication changes, allied health input or social facilitation.
Control group
Active

Outcomes
Primary outcome [1] 330101 0
DASS21 (Depression, Anxiety, Stress Scale 21)
Timepoint [1] 330101 0
Beginning and end of 6-week course (primary timepoints) and then 6 and 12 weeks afterwards
Primary outcome [2] 330102 0
SEMSI (Self Efficacy in Managing Social Identities)
Timepoint [2] 330102 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards
Primary outcome [3] 330186 0
PCS (Patient Catastrophising Scale)
Timepoint [3] 330186 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards
Secondary outcome [1] 404878 0
There would also be a qualitative, focus group component with questions about the acceptability and effectiveness of the program. Transcripts would be analysed using thematic analysis to identify key themes in the participants’ experiences.
This will be a composite outcome. Merged as part of the overall qualitative experience of the study.
Timepoint [1] 404878 0
At 2-26 weeks following completion of the group.
Secondary outcome [2] 405178 0
(Primary outcome) - PSEQ (Patient Self-Efficacy Questionnaire)
Timepoint [2] 405178 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards
Secondary outcome [3] 405179 0
(Primary outcome) - BPI (Brief Pain Inventory)
Timepoint [3] 405179 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards
Secondary outcome [4] 405180 0
(Primary outcome) - healthcare utilisation
This is measured by the number of presentations general practitioner, specialist, allied health, emergency, hospital admissions and number of diagnostic tests in last 3 months (self-reported)
Timepoint [4] 405180 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards
Secondary outcome [5] 405181 0
(Primary outcome) - patient perception of change
Measured by response to the following questions:
Compared with before treatment how would you describe yourself overall - 7 point likert scale (very much worse to very much better)
Compared with before treatment how would you describe your physical ability - 7 point likert scale (very much worse to very much better)
Timepoint [5] 405181 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards
Secondary outcome [6] 405182 0
(Primary outcome) - oral morphine equivalent daily dose
Self-reported opioid use converted to oral morphine equivalent daily dose via online calculator (available from Australian and New Zealand College of Anaesthetists http://www.opioidcalculator.com.au/opioidsource.html)
Timepoint [6] 405182 0
Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Eligibility
Key inclusion criteria
Chronic pain patients attending the Metro South Pain Rehabilitation Centre, Woolloongabba, Queensland, Australia
Able to attend in person, weekly for 5-6 weeks
Deemed appropriate and motivated for the course by Metro South Pain Rehabilitation Centre allied health
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant personality or mental health issues that would not work well with group dynamics

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation through shuffling identical opaque envelopes and dealing to treatment and control piles.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Details still to be confirmed.
Clinical significance benchmarks are set by the Australian Electronic Persistent Pain Outcomes Centre (EPPOC). These vary for the various primary outcome measures.
Statistical significance will be arbitrarily set at p=0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
3/11/2024
Actual
Date of last data collection
Anticipated
3/05/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21459 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 36362 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 310533 0
Government body
Name [1] 310533 0
Metro South Hospital and Health Service (Metro South Study, Education and Research Trust Account)
Country [1] 310533 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Aitcheson
Address
Metro South Pain Rehabilitation Centre
2 Burke St
Woolloongabba
QLD
4102
Country
Australia
Secondary sponsor category [1] 311706 0
None
Name [1] 311706 0
Address [1] 311706 0
Country [1] 311706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310156 0
Metro South Hospital and Health Service - Metro South Human Research Ethics Committee
Ethics committee address [1] 310156 0
Metro South HREC
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 310156 0
Australia
Date submitted for ethics approval [1] 310156 0
11/02/2022
Approval date [1] 310156 0
17/10/2022
Ethics approval number [1] 310156 0

Summary
Brief summary
The primary aim of this study is to find out whether a 5-6 session, small group, education and engagement course on social interaction and meaningful activity has an effect on pain, function and social networking.
There will also be a qualitative part of the study that looks at enjoyment, engagement and efficacy of the course and aims use this feedback to progressively improve the course over time.
Outcome measures for the main part of the study are quantitative, based on pain and function questionnaires and there is a control group who are waitlisted for twelve weeks prior to commencement of the study.
We hypothesise that there will be an increase in social connection, function and pain self-efficacy in the treatment group when compared to the control group, and that these increases will be seen at the end of the course and at 6 and 12-week follow up.
Trial website
Trial related presentations / publications
Public notes
Sessions will be conducted in person, however there is the option of telehealth (video) sessions if needed due to COVID requirements.
Attendance records will be kept for each session, including type of interaction (telehealth or in-person)

Contacts
Principal investigator
Name 116682 0
Dr Nicholas Aitcheson
Address 116682 0
Metro South Pain Rehabilitation Centre
2 Burke St
Woolloongabba
QLD
4102
Country 116682 0
Australia
Phone 116682 0
+61 7 31761901
Fax 116682 0
+61 7 31763969
Email 116682 0
nicholas.aitcheson@health.qld.gov.au
Contact person for public queries
Name 116683 0
Dr Nicholas Aitcheson
Address 116683 0
Metro South Pain Rehabilitation Centre
2 Burke St
Woolloongabba
QLD
4102
Country 116683 0
Australia
Phone 116683 0
+61 7 31761901
Fax 116683 0
+61 7 31763969
Email 116683 0
nicholas.aitcheson@health.qld.gov.au
Contact person for scientific queries
Name 116684 0
Dr Nicholas Aitcheson
Address 116684 0
Metro South Pain Rehabilitation Centre
2 Burke St
Woolloongabba
QLD
4102
Country 116684 0
Australia
Phone 116684 0
+61 7 31761901
Fax 116684 0
+61 7 31763969
Email 116684 0
nicholas.aitcheson@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
Numerical results from EPPOC questionnaires and SEMSI for all time points.
Gender and age of participants
When will data be available (start and end dates)?
June 2024 to June 2029
Available to whom?
Investigators formally requesting the data
Available for what types of analyses?
Meta-analyses, future chronic pain studies, confirmation of statistical results
How or where can data be obtained?
Access subject to approvals by Principal Investigator: nicholas.aitcheson@health.qld.gov.au


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.