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Trial registered on ANZCTR


Registration number
ACTRN12624000580572
Ethics application status
Approved
Date submitted
21/03/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Kneed: A pilot randomised trial of an online pain rehabilitation program to treat persistent pain after knee replacement for osteoarthritis
Scientific title
Kneed: A pilot randomised trial of an online pain rehabilitation program to treat persistent pain after knee replacement for osteoarthritis
Secondary ID [1] 311789 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent pain after knee replacement for osteoarthritis 333297 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329984 329984 0 0
Other physical medicine / rehabilitation
Anaesthesiology 330302 330302 0 0
Pain management
Musculoskeletal 330303 330303 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kneed group participate in an 8-week self-paced online pain rehabilitation program of education, exercise and strategies to treat pain, reduced function, dysfunctional sleep and stress. The program has been developed by NJ, a Rehabilitation Physician with 20 years + experience in treating pain. Kneed is unsupervised and is entirely online. It consists of written information, downloadable programs, quizzes and videos providing pain neuroscience education and strategies to self-manage pain. There are two introductory modules that take 30 minutes and then Participants can choose which modules they wish to do. Exercise is taught to be self-paced and is low to medium intensity, the time spent doing exercise is encouraged to be 30 minutes a day as a goal (usually walking). There are videos demonstrating balance, strength and range of motion exercises for the knee. It is limited to people living in Australia with internet access. Adherence is not monitored but there is a downloadable goal sheet for exercise and functional activities chosen by the participant. Strategies for pain include pacing, exercise, sleep management, relaxation, progressive muscular relaxation, goal setting and motor imagery. The program is not personalised.
Intervention code [1] 328238 0
Rehabilitation
Intervention code [2] 328460 0
Treatment: Other
Comparator / control treatment
Usual care - waitlist control. Participants in the usual care group can continue with their current management guided by their GP or clinicians and will be able to participate in the program at the end of 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 337751 0
Feasibility
Timepoint [1] 337751 0
At 8 weeks (intervention group): % completing 1 hour assessed
At the conclusion of the study: recruitment and eligibility
Primary outcome [2] 338044 0
Acceptability
Timepoint [2] 338044 0
a. For 8 weeks after starting intervention
b. Following completion of the program
Primary outcome [3] 338045 0
usability
Timepoint [3] 338045 0
At completion - 8 weeks after starting the intervention
Secondary outcome [1] 433136 0
Pain
Timepoint [1] 433136 0
Baseline (at enrolment), 4 weeks and 8 weeks after starting program or waitlist control
Secondary outcome [2] 433137 0
Function
Timepoint [2] 433137 0
Baseline (at enrolment), 4 weeks and 8 weeks after starting program or waitlist control
Secondary outcome [3] 433138 0
Quality of Life
Timepoint [3] 433138 0
Baseline (at enrolment) and 8 weeks after starting program or waitlist control
Secondary outcome [4] 434510 0
Pain
Timepoint [4] 434510 0
Baseline (at enrolment), 4 weeks and 8 weeks after starting program or waitlist control
Secondary outcome [5] 434511 0
Depression
Timepoint [5] 434511 0
Baseline (at enrolment)and 8 weeks after starting program or waitlist control
Secondary outcome [6] 434512 0
Catastrophizing
Timepoint [6] 434512 0
Baseline (at enrolment) and 8 weeks after starting program or waitlist control
Secondary outcome [7] 434513 0
Pain Self-efficacy
Timepoint [7] 434513 0
Baseline (at enrolment)and 8 weeks after starting program or waitlist control
Secondary outcome [8] 434514 0
Patient Global Impression of Change
Timepoint [8] 434514 0
8 weeks after starting program or waitlist control
Secondary outcome [9] 434751 0
Anxiety
Timepoint [9] 434751 0
Baseline (at enrolment) and 8 weeks after starting program or waitlist control
Secondary outcome [10] 434752 0
Stress
Timepoint [10] 434752 0
Baseline (at enrolment) and 8 weeks after starting program or waitlist control

Eligibility
Key inclusion criteria
Persistent pain > 3/10 on Numerical Rating Scale in index knee
>3 months after total knee replacement for osteoarthritis
internet access and email
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of rheumatoid or other inflammatory arthritis
Likely to undergo knee or other surgery in the next 3 months
Active illness from any medical condition that makes exercise potentially unsuitable such as unstable angina
Inability to walk within their household

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, consecutively numbered envelopes containing the group A or B based on the computer-generated sequence will be used to allocate each participant by a research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks of varying length, as recommended by CONSORT, will be employed using Stata Software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome, this program will be considered feasible if the criteria are met for recruitment and the majority of participants find the program usable, completed the introduction modules and spent > 1 hour on the program as above.
For the secondary outcomes, descriptive statistics will be provided to measure the differences between baseline and final outcomes although there will be no tests of significance performed due to the nature of a feasibility trial. Any adverse events occurring will be recorded.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316120 0
University
Name [1] 316120 0
Monash University, School of Clinical Sciences
Country [1] 316120 0
Australia
Funding source category [2] 316125 0
Other Collaborative groups
Name [2] 316125 0
Epworth Monash Rehabilitation Medicine Unit
Country [2] 316125 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Epworth Monash Rehabilitation Medicine Unit
Address
Country
Australia
Secondary sponsor category [1] 318299 0
None
Name [1] 318299 0
Address [1] 318299 0
Country [1] 318299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314952 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314952 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 314952 0
Australia
Date submitted for ethics approval [1] 314952 0
11/12/2023
Approval date [1] 314952 0
13/03/2024
Ethics approval number [1] 314952 0
41207

Summary
Brief summary
Whilst most patients are satisfied with their outcomes after a total knee replacement, moderate to severe persistent knee pain, defined as pain persisting beyond 3 post-operative months following surgery, can affect 25% of people at 6-months. NJ’s PhD studies have found associations of persistent high pain with reduced function, and reduced health related quality of life. Other studies have found that pain persisting after a knee replacement can interfere with walking, general activity and mood and reduced quality of life. A literature review conducted as part of NJ’s PhD (unpublished) found no rehabilitation programs addressing persistent pain after knee replacement. NJ, during his PhD studies, has designed a web-based, self-paced, pain rehabilitation program called Kneed to treat pain, reduced function and reduced quality of life for those with persistent pain after total knee replacement for osteoarthritis. The program consists of pain neuroscience education, exercise, motor imagery, desensitization techniques, relaxation, sleep and cognitive strategies such as goal setting. Educational and other strategies aim to normalize movement patterns (by reducing protective movements) and engage participants in functional activities by empowering behavior change. Kneed is being evaluated for the first time in a research study but has been used by patients under clinical supervision from Dr NJ (a Rehabilitation Physician) in a clinical practice. The potential benefit of Kneed as a digital health solution is to provide low-cost treatment to a broad audience, not limited by location (for example, rural areas and cities without pain management services). There are currently no evidence-based treatments available for this persistent pain condition, Kneed aims to provide one.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133226 0
Prof John Olver
Address 133226 0
Epworth Healthcare, Suite 2.4, 32 Erin Street, Richmond, Victoria, Australia 3121
Country 133226 0
Australia
Phone 133226 0
+613 94268771
Fax 133226 0
Email 133226 0
john.olver@epworth.org.au
Contact person for public queries
Name 133227 0
John Olver
Address 133227 0
Epworth healthcare Suite 2.4, 32 Erin Street, Richmond, Victoria Australia, 3121
Country 133227 0
Australia
Phone 133227 0
+613 94268771
Fax 133227 0
Email 133227 0
john.olver@epworth.org.au
Contact person for scientific queries
Name 133228 0
Dr Nathan Johns
Address 133228 0
Epworth Healthcare, Suite 2.4, 32 Erin Street, Richmond, Victoria, Australia, 3121
Country 133228 0
Australia
Phone 133228 0
+613 94268771
Fax 133228 0
Email 133228 0
nathan.johns1@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified PROMS
When will data be available (start and end dates)?
Data will be available at completion of the study (December 2024) and held for 5 years.
Available to whom?
Researchers with justification
Available for what types of analyses?
Meta-analysis, peer review
How or where can data be obtained?
Nathan.johns1@monash.edu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21922Ethical approval  Nathan.johns1@monash.edu



Results publications and other study-related documents

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