ANZCTR - Registration

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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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Anaesthesiology

Pain management

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

Feasibility

Timepoint [1]

At 8 weeks (intervention group): % completing 1 hour assessed
At the conclusion of the study: recruitment and eligibility

Primary outcome [2]

Acceptability

Timepoint [2]

a. For 8 weeks after starting intervention
b. Following completion of the program

Primary outcome [3]

usability

Timepoint [3]

At completion - 8 weeks after starting the intervention

Secondary outcome [1]

Pain

Timepoint [1]

Baseline (at enrolment), 4 weeks and 8 weeks after starting program or waitlist control

Secondary outcome [2]

Function

Timepoint [2]

Baseline (at enrolment), 4 weeks and 8 weeks after starting program or waitlist control

Secondary outcome [3]

Quality of Life

Timepoint [3]

Baseline (at enrolment) and 8 weeks after starting program or waitlist control

Secondary outcome [4]

Pain

Timepoint [4]

Baseline (at enrolment), 4 weeks and 8 weeks after starting program or waitlist control

Secondary outcome [5]

Depression

Timepoint [5]

Baseline (at enrolment)and 8 weeks after starting program or waitlist control

Secondary outcome [6]

Catastrophizing

Timepoint [6]

Baseline (at enrolment) and 8 weeks after starting program or waitlist control

Secondary outcome [7]

Pain Self-efficacy

Timepoint [7]

Baseline (at enrolment)and 8 weeks after starting program or waitlist control

Secondary outcome [8]

Patient Global Impression of Change

Timepoint [8]

8 weeks after starting program or waitlist control

Secondary outcome [9]

Anxiety

Timepoint [9]

Baseline (at enrolment) and 8 weeks after starting program or waitlist control

Secondary outcome [10]

Stress

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University, School of Clinical Sciences

Address [1]

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Epworth Monash Rehabilitation Medicine Unit

Address [2]

Country [2]

Australia

Primary sponsor type

Other Collaborative groups

Name

Epworth Monash Rehabilitation Medicine Unit

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

https://www.monash.edu/researchoffice/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/12/2023

Approval date [1]

13/03/2024

Ethics approval number [1]

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

Prof John Olver

Address

Epworth Healthcare, Suite 2.4, 32 Erin Street, Richmond, Victoria, Australia 3121

Country

Australia

Phone

+613 94268771

Fax

john.olver@epworth.org.au

Contact person for public queries

Name

John Olver

Address

Epworth healthcare Suite 2.4, 32 Erin Street, Richmond, Victoria Australia, 3121

Country

Australia

Phone

+613 94268771

Fax

john.olver@epworth.org.au

Contact person for scientific queries

Name

Dr Nathan Johns

Address

Epworth Healthcare, Suite 2.4, 32 Erin Street, Richmond, Victoria, Australia, 3121

Country

Australia

Phone

+613 94268771

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
21922	Ethical approval			Nathan.johns1@monash.edu

Results publications and other study-related documents

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No additional documents have been identified.

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