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Trial registered on ANZCTR


Registration number
ACTRN12619001491156
Ethics application status
Approved
Date submitted
8/10/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive functional therapy for people with knee osteoarthritis who are at risk of not benefiting from total knee replacement.
Scientific title
A multiple singe-case series to investigate the process of cognitive functional therapy in candidates for total knee replacement for osteoarthritis at risk of non-response to surgery.
Secondary ID [1] 299499 0
None
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 314746 0
Condition category
Condition code
Musculoskeletal 313076 313076 0 0
Osteoarthritis
Mental Health 313234 313234 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Functional Therapy (CFT): All participants will receive CFT. CFT is best briefly described as an integrated, personalised, behavioural approach to the identification and management of modifiable multidimensional factors underlying a person’s pain and disability. CFT comprehensively operationalises and integrates a self-management program, targeting psychological (cognitive and emotional factors), physical (e.g. movement and avoidance) and lifestyle factors (e.g. obesity). The intervention is delivered by specially trained physiotherapists with at least 100 hours of experience in this approach. It will be delivered face-to-face in a clinical setting and will address these targets using a tailored behavioural self-management plan depending on which factors are dominant for each individual. The CFT intervention treatment components consists of: (1) Cognitive: Education focused on the reconceptualization of pain within a biopsychosocial context related to the person’s story and valued daily life goals. Negative pain beliefs related to radiological imaging are specifically addressed in this process. The role of unhealthy lifestyle on pain and disability will be explained (2) Functional training: Pain controllability is enhanced through normalization of postures and movements, discouraging pain behaviours, while safely performing feared and / or painful movements and activities in a graduated manner. These new learned movement behaviors are then incorporated into daily tasks with respect to levels of pain control. The movements and behaviours targeted will be tailored to the specific task the individual nominates they have most limitations with samples of common movements or behaviours include walking, moving from sitting to standing and negotiating stairs. (3) Lifestyle training: Increasing physical activity levels in a relaxed, confident, mindful manner while developing skills to enhance stress coping and sleep hygiene. Participants will be encouraged to perform some form of physical activity 3-5 times a week if they were not previously doing so. Physical activity will be increased on a personalized manner based on each individual’s goals. For instance, if the participant’s goal is to be able to walk for 60min daily, this activity will be introduced at the level of the person’s ability and progressed on a time contingent fashion (e.g. increase of 5min/week, or start with 20min 3x/week and progress to 5x/week then increased by 5min/week). To monitor participant’s adherence to lifestyle training, participants may be encouraged to keep an exercise/activity diary. This however will be at an individual basis and the discretion of the clinician. In addition, participants will be wearing an activity monitor (activPALTM) over one week, on eight occasions over the study period. The activPALTM (PAL Technologies Ltd, Glasgow, UK) to quantify free-living sedentary, upright and ambulatory activities.

Treatment dosage for all participants will be up to 8 sessions in total over the 12-week intervention. The initial session will be 1hr and follow-ups of 30–45 min. Participants will be seen weekly for 2-3 sessions and progressed to one session every 2–3 weeks. Participants will be requested to practice the strategies at home, and to become increasingly aware of both physical and psychosocial dimensions to their pain, both during and after the intervention period.

Participants are requested to practice the strategies at home (the patient is encouraged to practice the strategies whenever they perform the movement/postural task throughout the day. This is usually on a daily basis however does depend on the patient) and to become increasingly aware of both physical and psychosocial dimensions to their pain, both during and after the intervention period. Adherence to the at-home practice will be monitored by a single question (“Over the past week, how many days have you practiced your management routine?”) asked weekly during the intervention and follow up periods.

Psychologically-based weight loss intervention: For those participants for whom weight is assessed as being a significant contributor to pain and disability, a psychologically-based weight loss intervention will be delivered by a Psychologist in conjunction with CFT. This consists of a 14-week online weight management program supplemented by additional psychological coaching face to face or via Skype (30min/week for 12 weeks, in addition to online modules), enabling the program to be individualized. The program has two key phases – and these are described below:

Preparation (2 Modules): A process that leads the person from preparation and planning to action and setup for maintenance
1. Preparing the mind.
2. Preparing the body.

Active Weight Loss (12 Modules): In addition to the core learnings from each module described below, each module also includes additional nutrition information and exercises, and exercise challenges.
1. ‘Old Brain, New Brain’: Understanding our basic human.
2. ‘Hierarchies of Control’: Environmental management strategies to reduce exposure to ‘high risk’ situations, and develop effective management strategies where exposure cannot be limited.
3. ‘Rewiring Habits’: Simple strategies for habit change – primarily a behavioural focus identifying alternative habits to replace unhealthy habits.
4. ‘Motivation’: Understanding how motivation works, and how motivation changes during the course of behavioural change.
5. The Magic Pills of Success’: Focus on sleep, using exercise for appetite control, and being aware of common cognitive distortions such as the halo effect.
6. ‘OOPS’: Preparing for and managing relapse.
7. ‘Mindfulness’: Strengthening impulse control.
8. ‘Help I’m Hungry’: Learning to differentiate between and manage hunger and cravings.
9. ‘Stress Management’: The role between stress and weight.
10. We are what we think: Cognitive restructuring
11. ‘Mood Control’: Strategies to with mood management.
12. Review: Review and preparation for maintenance.

Each module (week) consists of a 20-40 min video, plus some additional paper and pencil activities (average 10 mins). Ongoing encouragement and support is provided to all during the program via email. In addition to providing dietician designed diet and exercise plans, it focuses primarily on providing clients with the psychological tools necessary to sustain change. Where indicated, participants will also be provided with support for the use meal replacements (e.g. recommendation of specific products and design of a plan for meal replacements will be provided, but participants will pay for the products privately).

The weight loss program and exercise plans are set at the discretion of the dietitian and prescribed from the start. A food and exercise diary will be used to monitor adherence to the weight loss intervention and exercise plan.

A 8-week baseline control phase includes the collection of movement, pain, activity limitation and psychological factor data on five occasions (weekly). No intervention will be provided during this phase.
Intervention code [1] 315755 0
Treatment: Other
Intervention code [2] 315756 0
Rehabilitation
Intervention code [3] 315757 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321622 0
Activity Limitation
Patient Specific Functional Scale
Timepoint [1] 321622 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 motnhs after commencing treatment).
Primary outcome [2] 321623 0
Activity Limitation
Knee Injury and Osteoarthritis Outcome Scale Function sub-scale
Timepoint [2] 321623 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Primary outcome [3] 321624 0
Pain
Numeric Rating Scale (NRS – 0-10) for average intensity in the last week
Timepoint [3] 321624 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [1] 375616 0
"This is a primary outcome"
Pain
Knee Injury and Osteoarthritis Outcome Scale Pain Sub scale
Timepoint [1] 375616 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 motnhs after commencing treatment).
Secondary outcome [2] 375617 0
"This is a primary outcome"
Function
Physical tests (40m walking test)
Timepoint [2] 375617 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [3] 375618 0
"This is a primary outcome"
Function
Physical tests (sit to stand)
Timepoint [3] 375618 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [4] 375619 0
Secondary outcomes are factors that are related to treatment response (potential mediators from cognitive, behavioral and sensory dimensions)

Fear
2-item from The Knee Osteoarthritis Fears and Beliefs Questionnaire.
Timepoint [4] 375619 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [5] 375620 0
Fear
Single-item from the Brief Fear of Movement Scale.
Timepoint [5] 375620 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [6] 375621 0
Fear
The Knee Osteoarthritis Fears and Beliefs Questionnaire
Timepoint [6] 375621 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [7] 375622 0
Knee confidence
Single-item from the Knee Injury and Osteoarthritis Outcome Scale.
Timepoint [7] 375622 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [8] 375623 0
Pain self-efficacy
Two-item Pain Self-efficacy Questionnaire-2.
Timepoint [8] 375623 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [9] 375624 0
Pain control
Single-item from Coping Strategy Questionnaire
Timepoint [9] 375624 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [10] 375625 0
Pain control
Two-item Brief Pain Coping Inventory -2
Timepoint [10] 375625 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [11] 375626 0
Depression, Anxiety and Stress
Depression, Anxiety and Stress Scale.
Timepoint [11] 375626 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [12] 375627 0
Pain catastrophising
Three-item from the Pain Catastrophising Scale.
Timepoint [12] 375627 0
Weekly during baseline (8 weeks), treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [13] 375628 0
Pain catastrophising
Pain Catastrophising Scale
Timepoint [13] 375628 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [14] 375629 0
Activity levels
ActivPALTM (PAL Technologies Ltd, Glasgow, UK) will be used to quantify free-living sedentary, upright and ambulatory activities
Timepoint [14] 375629 0
Over one week twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (over one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [15] 375630 0
Tissue sensitivity (Pain Pressure Treshold)
Pressure algometer (Somedic AB, Sweden) with a contact area of 1 cm2 applied perpendicularly to the skin with a ramp rate of 50kPa/s.
Timepoint [15] 375630 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [16] 375631 0
Movement
Two Inertial Measurement Units (IMUs) with tri-axis gyroscopes, accelerometers, and magnetometers. These devices will measure knee kinematics during common and nominated tasks that individuals with knee OA report as dificult or avoided
Timepoint [16] 375631 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [17] 375632 0
Eating self-regulation (*only asked in participants completing weight management program)
Single item adapted from Self Regulation of Eating Behaviour Questionnaire.
Timepoint [17] 375632 0
Weekly during treatment period (12 weeks) and follow-up period (one week at 6, 9 and 12 months after commencing treatment).
Secondary outcome [18] 375633 0
Weight (*only asked in participants completing weight management program)
Self reported weight
Timepoint [18] 375633 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).
Secondary outcome [19] 375634 0
Weight Self-Efficacy (*only asked in participants completing weight management program)
Weight Efficacy Lifestyle Questionnaire
Timepoint [19] 375634 0
Twice during baseline (weeks 1 and 8), three times during treatment period (weeks 4, 8 and 12) and follow-up period (at 6, 9 and 12 months after commencing treatment).

Eligibility
Key inclusion criteria
- Patient assessed as being at >15% risk for non-response according to a prognostic nomogram (Dowsey et al., 2016).

- Patient willing to undergo an intensive rehabilitation program.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients assessed as <15% risk of non-response according to aforementioned nomogram,

- Previous major ipsilateral knee surgery

- Women who are pregnant or seeking to become pregnant during the study period

- The individual is mentally compromised (i.e., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse), and is unwilling or unable to comply with scheduled evaluations and/or rehabilitation,

- Comorbidities causing severe mobility impairment (e.g. limb amputation, multiple sclerosis, muscular dystrophy, Parkinson’s disease, morbidly obese, hemiplegic, lower limb fracture).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Participants will act as their own control. This will be achieved by collecting 8 consecutive weeks of measures to form a baseline before the intervention phase.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: The factors independently predicting non-response to total knee replacement arevaried and include lower disease severity, obesity and poorer levels of general mental wellbeing. Cognitive Functional Therapy (CFT) likely offers promise for some people unsuitable for total knee replacement, but this treatment has been developed and tested in the field of low back pain, and before testing it in RCTs in this group of people, we need to understand more about i) which individual profiles it may be most helpful for and ii) how content might be best tailored. Single-case designs are common in the behavioural sciences and particularly useful to inform personalised treatments for patients. They may be considered complementary rather than opposing to ‘nomothetic’ approaches which use large samples to estimate averaged group effects. Eight single-case studies are proposed such that each case separately informs our understanding of optimal treatment components and individual profiles for CFT response. We will recruit people presenting to surgery assessed as at risk of non-response by the predictive nomogram, but this risk will be conferred by varying contributions of risk factors. It is anticipated that 8 subjects will cover the heterogeneity inherent in this combination and allow an examination of CFT in different ‘contexts’, i.e. in terms of individuals with differing profiles. We will adhere to the CONSORT extension for reporting N-of-1 trials 2015 statement.

Analysis Plan: In addition to conventional interpretation of single-case data using visual inspection of graphed data for each outcome and potential mediator within and across phases, the conservative dual control method will be utilised to assess the presence of a systematic change in variables during phase B. This method has been shown to have low rates of Type I and II error in the presence of auto-correlation. Internal validity for attribution of any systematic change to the intervention will be supported by interview content (patient and significant other) and therapist log, to identify explanations for change other than the intervention. Transcribed audio data from interviews exploring the participants' perceptions and beliefs of the understanding of their condition and an evaluation of contributing factors of any change will be analysed using an inductive analytic approach described by Thorne et al (2004) Int J Qual Methods. It involves five steps: 1) open coding, 2) intra-subject analysis: salient coding, 3) inter-subject analysis: search for patterns between participants, 4) identification of emerging themes and 5) interpretive description of findings.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
11/07/2018
Date of last participant enrolment
Anticipated
Actual
29/08/2019
Date of last data collection
Anticipated
15/01/2021
Actual
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303998 0
Government body
Name [1] 303998 0
NHMRC - National Health Medical Research Council
Country [1] 303998 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley Western Australia. GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 304171 0
University
Name [1] 304171 0
University of Melbourne
Address [1] 304171 0
Grattan Street, Parkville VIC 3010
Country [1] 304171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304491 0
University of Melbourne Behavioural and Social Sciences Human Ethics Sub-Committee
Ethics committee address [1] 304491 0
Grattan Street, Parkville VIC 3010
Ethics committee country [1] 304491 0
Australia
Date submitted for ethics approval [1] 304491 0
10/02/2017
Approval date [1] 304491 0
09/05/2017
Ethics approval number [1] 304491 0
1646845

Summary
Brief summary
There is an imperative to find alternative care pathways for the 15% of people who are unlikely to benefit from knee total joint replacement (TJR). Chronic low back pain shares a similar multi-dimensional risk profile to knee joint osteoarthritis. Much effort has been directed to developing targeted treatment to subgroups of people with chronic low back pain who have poorer prognosis based on their group profiles. In keeping with this, this research group has developed an individualised model of care for chronic low back pain that effectively targets the multidimensional complexity of the disorder, termed ‘cognitive functional therapy’ (CFT) (Vibe Fersum, et al. 2019). Such an approach may offer a promising alternative to knee TJR in those patients at risk of poor outcome with the procedure, but before this intervention can be tested in randomised, controlled trials there is a need to explore the potential effectiveness, treatment mechanisms and moderators in this population. The main aim of this study is to test Cognitive Functional Therapy in a small but diverse sample of eight people with knee osteoarthritis who are at risk of not benefitting from a total knee replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97134 0
Prof Anne Smith
Address 97134 0
Curtin University, Kent St, Bentley WA 6102
Country 97134 0
Australia
Phone 97134 0
+61 8 92663622
Fax 97134 0
Email 97134 0
[email protected]
Contact person for public queries
Name 97135 0
Anne Smith
Address 97135 0
Curtin University, Kent St, Bentley WA 6102
Country 97135 0
Australia
Phone 97135 0
+61 8 92663622
Fax 97135 0
Email 97135 0
[email protected]
Contact person for scientific queries
Name 97136 0
Anne Smith
Address 97136 0
Curtin University, Kent St, Bentley WA 6102
Country 97136 0
Australia
Phone 97136 0
+61 8 92663622
Fax 97136 0
Email 97136 0
[email protected]

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 data underlying published results only.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of the research team.
Available for what types of analyses?
For any scientific purpose that meets the research team’s approval.
How or where can data be obtained?
Access subject to approvals by research team. There will be a requirement to sign a data access agreement. Contact: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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