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Pain Education to Optimise Care for Total Knee Replacement Surgery (OPTIMISE)

An Osteoarthritis Pain Science Education Intervention to Optimise Care for Total Knee Replacement Surgery (OPTIMISE)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001288415
Acronym
OPTIMISE
Enrollment
80
Registered
2025-11-19
Start date
2026-09-01
Completion date
2026-12-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Post total knee replacement surgery, approximately 34% of people have a poor clinical outcome with approximately 15% developing chronic post-surgical pain (long-lasting severe-extreme pain) after surgery. Post total knee replacement pain outcomes can be improved via early graded resumption of activity and early targeted medical attention if not improving. However, current total knee replacement care does not always facilitate this. Physiotherapist led pain science education to update inaccurate beliefs about pain, paired with activity goals has demonstrated reductions in pain and improved self-rated activity for people with knee osteoarthritis. Thus, we have now co-designed a total knee replacement-specific pain science-education intervention with osteoarthritis consumers and clinicians that is ready to pilot test. This parallel-group randomised controlled trial aims to determine whether pain science education informed optimised care for total knee replacement surgery is feasible, acceptable and demonstrates the potential for efficacy when embedded into Australian hospitals relative to usual care.

Interventions

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 reha

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 will receive up to 12 sessions (total) of pain science education-informed optimised care provided pre- and post-operatively. Participants (and a carer/family member if requested) will be provided individualised education about their pain using tools such as the Protectometer (helps identify individualised contextual contributors to pain) and will develop individualised activity goals with guidance on how to achieve these (using principles of graded activity – ‘start low, go slow’). The specific educational content and method of intervention delivery will be informed by the results of Stage 1 of this project. We will update the record with full details regarding the intervention (content, mode of training e.g. interactive activities / short videos, the frequency and duration of intervention sessions before and after surgery) before the study begins. Participants will be offered opportunity to receive the intervention in person at the University of South Australia’s Clinical Trial Facility or the South Australian Health and Medical Research Institute, via telehealth, or via a hybrid model. Education will be delivered by a physiotherapist trained in pain science education. A session attendance log will be used to monitor intervention attendance / adherence. Additionally, this group will receive access to a custom pain science educational website from study enrollment to support their learning. Participants will retain access to the website after the final follow up (12 months post total knee replacement).

Sponsors

University of South Australia
Lead SponsorUniversity
Adelaide University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026