ANZCTR - Registration

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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]

RSS_2022_133

Secondary ID [2]

ION80003456

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic pain

Social isolation

Anxiety

Depression

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Anaesthesiology

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

DASS21 (Depression, Anxiety, Stress Scale 21)

Timepoint [1]

Beginning and end of 6-week course (primary timepoints) and then 6 and 12 weeks afterwards

Primary outcome [2]

SEMSI (Self Efficacy in Managing Social Identities)

Timepoint [2]

Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Primary outcome [3]

PCS (Patient Catastrophising Scale)

Timepoint [3]

Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Secondary outcome [1]

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]

At 2-26 weeks following completion of the group.

Secondary outcome [2]

(Primary outcome) - PSEQ (Patient Self-Efficacy Questionnaire)

Timepoint [2]

Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Secondary outcome [3]

(Primary outcome) - BPI (Brief Pain Inventory)

Timepoint [3]

Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Secondary outcome [4]

(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]

Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Secondary outcome [5]

(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]

Beginning and end of 6-week course (primary timepoint) and then 6 and 12 weeks afterwards

Secondary outcome [6]

(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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Metro South Hospital and Health Service (Metro South Study, Education and Research Trust Account)

Address [1]

Translational Research Institute 37 Kent St Woolloongabba QLD 4102

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Hospital and Health Service - Metro South Human Research Ethics Committee

Ethics committee address [1]

Metro South HREC
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/02/2022

Approval date [1]

17/10/2022

Ethics approval number [1]

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

Dr Nicholas Aitcheson

Address

Metro South Pain Rehabilitation Centre 2 Burke St Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 31761901

Fax

+61 7 31763969

[email protected]

Contact person for public queries

Name

Nicholas Aitcheson

Address

Metro South Pain Rehabilitation Centre 2 Burke St Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 31761901

Fax

+61 7 31763969

[email protected]

Contact person for scientific queries

Name

Nicholas Aitcheson

Address

Metro South Pain Rehabilitation Centre 2 Burke St Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 31761901

Fax

+61 7 31763969

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Investigators formally requesting the data

Conditions for requesting access:
• -

What individual participant data might 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

What types of analyses could be done with individual participant data?

• Meta-analyses, future chronic pain studies, confirmation of statistical results

When can requests for individual participant data be made (start and end dates)?

From:
June 2024 to June 2029

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator: [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically