Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001004954
Ethics application status
Approved
Date submitted
18/06/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a non-surgical physiotherapy-led alternative (Cognitive Functional Therapy) for people with knee osteoarthritis .
Scientific title
Cognitive Functional Therapy for people with knee osteoarthritis: Feasibility of conducting an RCT to test a non-surgical alternative for people who have been recommended total knee replacement.
Secondary ID [1] 301568 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 317933 0
Condition category
Condition code
Musculoskeletal 315966 315966 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Functional Therapy (CFT): All participants in the treatment group will receive CFT. CFT is best briefly described as a personalised, cognitive and 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 lifestyle (e.g. obesity) factors. The intervention is delivered by specially trained physiotherapists with at least 100 hours of experience in this approach. CFT will be delivered face-to-face in a clinical setting and will address these targets using a tailored cognitive and behavioural self-management plan, depending on which factors are dominant for each individual. The CFT intervention treatment has three components:
(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 and tissue damage are specifically addressed in this process. The role of unhealthy lifestyle factors on pain and disability will be explained.
(2) Functional training: Pain controllability is enhanced through normalization of postures and movements, discouraging pain behaviours, while building confidence to gradually engage in feared and / or painful movements and activities. These new learned movement behaviors are gradually incorporated into daily tasks. The movements and behaviours targeted will be tailored to the specific functional goals of the individual. Examples 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 healthy sleep habits.
Treatment dosage for all participants will be up to 10 sessions in total including, 7 sessions over the 12-week intervention, and 3 booster sessions. The boosters sessions can be triggered by the patient in case of a flare up or need of assistance. If the patient does not make contact, the booster sessions will occur at 2, 4 and 6 months after the end of the 12-week intervention period. Patients will be offered to come in or have an online video consult with the Physiotherapist for these three sessions. This will be based on the participant’s preference. 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. Adherence to the at-home practice will be monitored by a single question (“Over the past week, how many days have you engaged in your management plan?”) asked weekly during the intervention and follow up periods.

To integrate care with members of other health disciplines, the CFT physiotherapist will liaise with the participant’s GP, and refer on to a psychologist and or a dietician as indicated by the presence of health co-morbidities such as mental health disorders and obesity.
Intervention code [1] 317863 0
Treatment: Other
Intervention code [2] 317864 0
Rehabilitation
Intervention code [3] 317865 0
Behaviour
Comparator / control treatment
Usual care: This treatment will be the usual care pathway the participant's health providers recommend and/or the participant chooses. Usual care may consist of physiotherapy, medication, injections, rest, wearing a brace, keep active or surgical procedures such as arthroscopy and joint replacement. Treatment in this group will not be impacted in any way by participation in the study.
Control group
Active

Outcomes
Primary outcome [1] 324180 0
FEASIBILITY OF RECRUITMENT

1. Reported number and the percentage of eligible participants consented into the trial per month as a proportion of participants invited.

2. The number of individuals screened for eligibility, the number eligible and invited to participate and the number that consented to participate per recruitment site. When available, the reasons for not entering the study will be recorded.
Timepoint [1] 324180 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Primary outcome [2] 324181 0
FEASIBILITY OF PARTICIPATION
1. Reported number and the percentage of acceptability of random allocation to a treatment
group, and losses to follow-up. The research assistant will ask all participants during recruitment if being randomly allocated to one of the two treatments is acceptable to them.
Timepoint [2] 324181 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Primary outcome [3] 324387 0

ACCEPTABILITY

A semi-structured interview with intervention participants who complete the study will be conducted to gather data on their experience, relating to acceptability of the intervention and the research process as experienced by both patients and physiotherapists will be explored. Each interview will be one-on-one and it will take between 30-60 minutes for completion. The interviews will be in person, or over the phone if more convenient to the participant. The interviews will be audio-recorded digitally. After the interview the recording will be transcribed verbatim for analysis.
Timepoint [3] 324387 0
3 months and at 6 months post-randomization.
Secondary outcome [1] 383939 0
Disability/Physical function

Instrument: KOOS - Knee Injury and Osteoarthritis Outcome Scale function subscales
Timepoint [1] 383939 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [2] 383940 0
Task-specific knee pain

Measured by the KOOS - Knee Injury and Osteoarthritis Outcome Scale Pain Subscale
Timepoint [2] 383940 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [3] 383941 0
Pain catastrophising

Instrument: Pain Catastrophising Scale
Timepoint [3] 383941 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [4] 383942 0
Pain self-efficacy

Instrument: Pain Self-efficacy Questionnaire.
Timepoint [4] 383942 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [5] 383943 0
Fear and Beliefs

Instrument: The Knee Osteoarthritis Fears and Beliefs Questionnaire.
Timepoint [5] 383943 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [6] 383944 0
Knee confidence

Instrument: single-item from the Knee Injury and Osteoarthritis Outcome Scale.
Timepoint [6] 383944 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [7] 383945 0
Psychological distress

Instrument: Depression, Anxiety and Stress Scale.
Timepoint [7] 383945 0
Baseline (Pre-randomization), at 3 months and at 9 months post-randomization.
Secondary outcome [8] 383946 0
Pain control

Instrument : single-item from Coping Strategy Questionnaire
Timepoint [8] 383946 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [9] 383947 0
Quality of life

Instrument: EQ-5D-5L questionnaire.
Timepoint [9] 383947 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [10] 383948 0
BMI

Instrument: Self reported weight and height
Timepoint [10] 383948 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [11] 383949 0
Global Rating of Change

Instrument: 7-point Global Rating of Change scale.
Timepoint [11] 383949 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [12] 384529 0
PRIMARY OUTCOME

FEASIBILITY OF OUTCOME ASSESSMENT (1)
1. Time taken to complete patient reported outcome measures at all time points. The online platform used for the questionnaires measures the time taken for completion by each participant.
Timepoint [12] 384529 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [13] 384530 0
PRIMARY OUTCOME

FEASIBILITY OF MEASURES OF COMPLETENESS OF DATA COLLECTION
The number of participants who responded for each of the secondary outcomes at each timepoint will be counted; with > 80% of completed data used as criteria to consider the study feasible.
Timepoint [13] 384530 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [14] 384531 0
PRIMARY OUTCOME

FEASIBILITY OF TREATMENT (1)
Adherence - the percentage of participants adhering with the CFT intervention measured treatment attendance (80% as criteria) and response to specific question about compliance with management plan.
Timepoint [14] 384531 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [15] 384532 0
PRIMARY OUTCOME

ADVERSE EVENTS
1. Defined as any morbidity or events causing unwarranted distress to a participant that were potentially related to any trial-related intervention.
2. Tailored question, based on recommendations of the CIOMS Working Group VI (World Health Organization. International ethical guidelines for health-related research involving humans: Geneva: Council for International Organizations of Medical Sciences 2016). Clinicians and follow-up questionnaires will inquire about any adverse events.
Timepoint [15] 384532 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [16] 384568 0
Fear and Beliefs

Qualitative themes relating to patient’s fears and beliefs about Osteoarthritis will be explored through semi-structured interviews. Each interview will be one-on-one and it will take between 30-60 minutes for completion. The interviews will be in person, or over the phone if more convenient to the participant. The interviews will be audio-recorded digitally. After the interview the recording will be transcribed verbatim for analysis.
Timepoint [16] 384568 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [17] 385805 0
Global knee pain intensity

Measured by a Numeric Rating Scale (NRS – 0-10) for average pain intensity in the last week. NRS anchored on 0 (No pain) and 10 (Worst pain imaginable)
Timepoint [17] 385805 0
Baseline (Pre-randomization), at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.
Secondary outcome [18] 385807 0
PRIMARY OUTCOME

FEASIBILITY OF OUTCOME ASSESSMENT (2)

Acceptability of screening procedures
The lead researcher will interview the research assistant screening the patients for eligibility by asking the following question: "Were there any difficulties or challenges in screening and recruiting the participants for the trial?"
Timepoint [18] 385807 0
At the end of recruitment.
Secondary outcome [19] 385811 0
PRIMARY OUTCOME

FEASIBILITY OF TREATMENT (2)

Crossover (Contamination between the groups) - the percentage of participants that crossed over between groups. That is, patients in the usual care arm that sought CFT, and patients in CFT arm that sought other care.
Timepoint [19] 385811 0
3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.

Eligibility
Key inclusion criteria
Adults aged greater than or equal to 40 with clinical diagnosis of knee OA based on guideline-recommended criteria that indicate joint pain and functional limitation without the need for investigations (NICE-OA 2014:
* report persistent knee pain for more than 3 months and for most days of the past month;
* report a minimum average knee pain intensity over the past week of 4 on an 11-point numerical rating scale (NRS, with terminal descriptors of ‘no pain’ and ‘worst pain possible’);
* have seen an orthopaedic consultant who recommended (offered or suggested) knee replacement surgery as a treatment option for pain, now or in the future
* have an active email account and access to a computer for completion of online questionnaires
* Able to commit approximately 9-12 months to the study and willing to do regular home exercises if allocated to the CFT group.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients will be excluded if they have any comorbidities resulting in a severe mobility impairment (e.g. limb amputation, multiple sclerosis, muscular dystrophy, Parkinson's disease, hemiplegic, lower limb fracture); have a serious pathology (fracture, infection, cancer); are pregnant or have given birth within 3 months; or have Systemic arthritic condition.
* Have had, or are planning, intra-articular injection therapy on the painful knee within the past/next 3 months
* Lack of adequate English comprehension to complete the study's questionnaires and instructions.

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)
Randomisation will be 1:1 in permuted blocks of 4. One of the senior researchers, who is a biostatistician, will generate the randomisation schedule and prepare opaque numbered envelopes containing the allocation for each participant, which will be transferred and held at Physiotherapy clinic. Upon consent and completion of the pre-treatment assessment (online questionnaires and qualitative interview), the RA will assign each participant the next sequential Study ID number and open the corresponding envelope, then proceed with scheduling the patient for the first CFT treatment session or for usual care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatistician. Randomisation will be by random permuted blocks of 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size: A sample of 49 in each arm will be sufficient to detect primary outcome dropout rates of 23% or more with 90% power, and will have 99% power to detect an unacceptable dropout rate of 30%, compared to an acceptable dropout rate of 10%.

Analysis Plan:

Primary outcomes:
Descriptive statistics will be calculated with 95% confidence intervals and compared against pre-planned criteria for feasibility: greater or equal to 70% of sample can be recruited; greater or equal to 80% participants are retained; greater or equal to 80% of participants provide follow-up data at 3 months post-randomization, 6 months post-randomization, and 12 months post-randomization.

The following parameters were set to inform feasibility: (i) a recruitment rate of 1 participant per week; (ii) minimum adherence to the intervention of 70% of the sessions during the treatment period 5 of 7 days); and (iii) a drop-out rate of less than or equal to 20%.

Transcribed audio data from audio-recorded interviews exploring the participants' perceptions and beliefs of the understanding of their condition and acceptability of the CFT intervention to both patients and physiotherapists, and data collection processes to patients. To enhance variability and to limit selection bias, a purposive sample of responders and non-responders to the interventions (identified using a minimum clinically important change threshold of <30% change in KOOS - Knee Injury and Osteoarthritis Outcome Scale Function or Pain subscales) will be invited to participate.

Secondary outcomes:
95% confidence intervals for within and between group difference in degree and sustainability of improvement in knee pain-related disability (KOOS), pain intensity (NRS), psychological factors (fear beliefs, knee confidence, pain self-efficacy, pain control, depression, anxiety and stress, pain catastrophising), quality of life (EQ-5D-5L), and Global change rating at 3, 6 and 12 months will be estimated using linear mixed models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305999 0
Government body
Name [1] 305999 0
WA Health Department
Country [1] 305999 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] 306462 0
None
Name [1] 306462 0
Address [1] 306462 0
Country [1] 306462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306234 0
Curtin University Human Research Ethics Committee (HREC) – Faculty of Health sciences Ethics Sub-Committee
Ethics committee address [1] 306234 0
Ethics committee country [1] 306234 0
Australia
Date submitted for ethics approval [1] 306234 0
23/10/2019
Approval date [1] 306234 0
07/01/2020
Ethics approval number [1] 306234 0
HRE2020-0004

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

Contacts
Principal investigator
Name 103194 0
Dr Joao Paulo Caneiro
Address 103194 0
Curtin University, kent St, Bentley WA 6102
Country 103194 0
Australia
Phone 103194 0
+61 8 92663622
Fax 103194 0
Email 103194 0
jp.caneiro@curtin.edu.au
Contact person for public queries
Name 103195 0
Joao Paulo Caneiro
Address 103195 0
Curtin University, kent St, Bentley WA 6102
Country 103195 0
Australia
Phone 103195 0
+61 8 92663622
Fax 103195 0
Email 103195 0
jp.caneiro@curtin.edu.au
Contact person for scientific queries
Name 103196 0
Joao Paulo Caneiro
Address 103196 0
Curtin University, kent St, Bentley WA 6102
Country 103196 0
Australia
Phone 103196 0
+61 8 92663622
Fax 103196 0
Email 103196 0
jp.caneiro@curtin.edu.au

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)?
Different aspects of the data will be published separately, which will determine when those data are publicly available. Broadly, individual participant data will be available from July 2022 to July 2027.
Available to whom?
On a 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 which will require a commitment to using the data only for specified research purposes, to securing the data appropriately and to destroying the data after a nominated period. Contact the project lead (Joao Paulo Caneiro, jp.caneiro@curtin.edu.au).


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.