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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001288415
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/10/2025
Date registered
Help: Date registered
19/11/2025
Date last updated
Help: Date last updated
21/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Education to Optimise Care for Total Knee Replacement Surgery (OPTIMISE)
Scientific title
An Osteoarthritis Pain Science Education Intervention to Optimise Care for Total Knee Replacement Surgery (OPTIMISE)
Additional trial identifiers [1] 315076 0
MRFF2039912
Universal Trial Number (UTN)
Trial acronym
OPTIMISE
Related trial records

Health condition
Health condition(s) studied:
Osteoarthritis 338472 0
Total knee arthroplasty 338473 0
Condition category
Condition code
Musculoskeletal 334766 334766 0 0
Osteoarthritis
Surgery 334767 334767 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This interventional study aims to evaluate the feasibility, acceptability and potential efficacy of pain science education informed optimised care for total knee replacement surgery.

The hospitals will provide usual pre- and post-operative care inclusive of pre- and post-operative appointments and follow-up procedures to all participants (experimental and control groups). This will occur according to the hospitals' standard procedures and may involve pre-operative education, post-operative rehabilitation (via home exercise or a formal program), medication or other medical service prescription. For this project, all participants will receive additional education to usual care,

The pain science education (experimental) group (and a carer/family member if requested) will receive will receive access to a custom pain science educational website from study enrollment. This will contain education about pain neuroscience and osteoarthritis, preparing for and recovery from total knee replacement surgery. To help participants apply their knowledge, the website will contain activities and tools such as the Protectometer (helps identify individualised contextual contributors to pain) and information on how participants can develop individualised activity goals with guidance on how to achieve these (using principles of graded activity – ‘start low, go slow’) To support their learning, participants will be offered up to 12 sessions (total) with a physiotherapist to help them review the pain science education-informed educational material. The first session will be up to 60 minutes and subsequent sessions up to 30 minutes in duration. The timing of each session will be flexible to accommodate each participants needs pre and post operatively and participants are not required to schedule all 12 sessions. Participants will be offered opportunity to receive the sessions in person at Adelaide University's Clinical Trial Facility or the South Australian Health and Medical Research Institute, at home, in hospital, via telehealth, or via a hybrid model. A session attendance log will be used to monitor intervention attendance / adherence. Participants will retain access to the website after the final follow up (12 months post total knee replacement).
Intervention code [1] 331698 0
Treatment: Other
Description of the comparator or control
Participants in the control group will receive access to a general educational website (or paper copy if requested) about total knee replacement surgery and recovery pre- and post-operatively. The website will not incorporate pain science education content. Participants will have access to this website from study enrollment and will retain access to the website upon conclusion of the intervention. Participants in this group will also be provided with access to the pain science education website after the final follow up (12 months post total knee replacement).
Control group
Active

Outcomes
Primary outcome [1] 342426 0
Knee pain
Timepoint [1] 342426 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [1] 450766 0
Knee stiffness
Timepoint [1] 450766 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [2] 450767 0
Knee function
Timepoint [2] 450767 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [3] 450768 0
Self-efficacy
Timepoint [3] 450768 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [4] 450769 0
Physical activity
Timepoint [4] 450769 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [5] 450770 0
Health related quality of life
Timepoint [5] 450770 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [6] 450771 0
Healthcare resource use (specific to knee pain)
Timepoint [6] 450771 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [7] 450772 0
Adverse events (in the study knee or elsewhere in the body) measured
Timepoint [7] 450772 0
3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [8] 450773 0
Knee perception
Timepoint [8] 450773 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [9] 450774 0
Fear of movement
Timepoint [9] 450774 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [10] 450775 0
Pain beliefs
Timepoint [10] 450775 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [11] 450776 0
Osteoarthritis conceptualisation (mediating factor)
Timepoint [11] 450776 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [12] 450777 0
Current knee pain
Timepoint [12] 450777 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [13] 450778 0
Intervention acceptability
Timepoint [13] 450778 0
Survey and interview at 6 months post total knee replacement, a second interview at 12 months post total knee replacement
Secondary outcome [14] 450780 0
Composite procedural outcome: Recruitment
Timepoint [14] 450780 0
Assessed at end of recruitment period
Secondary outcome [15] 450781 0
Procedural outcome: Eligibility
Timepoint [15] 450781 0
Assessed at end of recruitment period
Secondary outcome [16] 450782 0
Procedural outcome: Follow up retention
Timepoint [16] 450782 0
Assessed at the end of the intervention
Secondary outcome [17] 450783 0
Procedural outcome: All experimental group participants receive pre-surgical pain science education
Timepoint [17] 450783 0
Assessed at the conclusion of the study
Secondary outcome [18] 451739 0
Access to post surgical support
Timepoint [18] 451739 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement
Secondary outcome [19] 452268 0
Participants' engagement in healthcare and health decisions
Timepoint [19] 452268 0
Baseline, 3 months post total knee replacement, 6 months post total knee replacement and 12 months post total knee replacement

Eligibility
Key inclusion criteria
i) Participants must be scheduled to undergo total knee replacement surgery at The Queen Elizabeth Hospital, The Royal Adelaide Hospital or Calvary Adelaide Hospital.
ii) Participants will be required to meet NICE criteria for knee osteoarthritis: aged 50 years or above; have activity-related knee pain; no morning knee stiffness or stiffness lasting less than 1 hour in duration
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
i) Inflammatory arthritis (e.g. rheumatoid arthritis)
ii) Undergoing a total knee replacement revision
iii) Have neurological disorders that may affect the lower limb
iv) Do not have capacity to provide informed consent (e.g. cognitive impairment such as dementia)
v) Participating in another study that would interfere with the trial

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central automated randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated (1:1) using a simple randomisation schedule by the NHMRC Clinical Trial Centre central randomisation service. Randomisation will be conducted by an independent researcher not involved in data collection or trial intervention. Assignment will be stratified by hospital and sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A statistician blinded to group allocation will undertake analyses. Descriptive statistics will be calculated for feasibility/acceptability outcomes. Qualitative thematic analysis will be used to extract themes about experiences/perspectives from interviews, to optimise the design of a future randomised controlled trial. Consistent with feasibility study guidelines (evaluation of efficacy potential), paired t-tests will evaluate pre-/post-intervention change in clinical outcomes in each intervention group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319646 0
Government body
Name [1] 319646 0
Medical Research Future Fund, Australian Government Department of Health, Disability and Ageing
Country [1] 319646 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 322163 0
None
Name [1] 322163 0
Address [1] 322163 0
Country [1] 322163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318210 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 318210 0
Ethics committee country [1] 318210 0
Australia
Date submitted for ethics approval [1] 318210 0
29/10/2025
Approval date [1] 318210 0
03/12/2025
Ethics approval number [1] 318210 0
22160
Ethics committee name [2] 318224 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 318224 0
Ethics committee country [2] 318224 0
Australia
Date submitted for ethics approval [2] 318224 0
28/10/2025
Approval date [2] 318224 0
08/12/2025
Ethics approval number [2] 318224 0
Ethics committee name [3] 321237 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [3] 321237 0
Ethics committee country [3] 321237 0
Australia
Date submitted for ethics approval [3] 321237 0
04/12/2025
Approval date [3] 321237 0
04/06/2026
Ethics approval number [3] 321237 0

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

Contacts
Principal investigator
Name 143450 0
Prof Tasha Stanton
Address 143450 0
Adelaide University, North Terrace, Adelaide, South Australia 5005
Country 143450 0
Australia
Phone 143450 0
+618 8302 2090
Fax 143450 0
Email 143450 0
[email protected]
Contact person for public queries
Name 143451 0
Caitlin Prentice
Address 143451 0
Adelaide University, North Terrace, Adelaide, South Australia 5005
Country 143451 0
Australia
Phone 143451 0
+618 8302 1890
Fax 143451 0
Email 143451 0
[email protected]
Contact person for scientific queries
Name 143452 0
Tasha Stanton
Address 143452 0
Adelaide University, North Terrace, Adelaide, South Australia 5005
Country 143452 0
Australia
Phone 143452 0
+618 8302 2090
Fax 143452 0
Email 143452 0
[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:
• Case-by-case basis at discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Primary Investigator (email contact: [email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.