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Testing a non-surgical physiotherapy-led alternative (Cognitive Functional Therapy) for people with knee osteoarthritis .

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001004954
Enrollment
98
Registered
2020-10-06
Start date
2020-10-26
Completion date
2020-12-31
Last updated
2020-10-12

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

Conditions

None listed

Brief summary

Our research group has developed an individualised model of care for chronic low back pain termed ‘cognitive functional therapy’ (CFT), which showed to be superior to current physiotherapy treatment at one-year (Vibe Fersum et al 2013) and three-years follow up (Vibe Fersum et al 2019). With growing evidence that chronic low back pain and osteoarthritis share similar barriers to recovery, interventions targeting contributing factors at an individual level may offer a promising alternative for people with knee osteoarthritis. However, there are no randomized clinical trial examining the effects of a CFT intervention in people with knee osteoarthritis. The primary aim of this study is to determine the feasibility of conducting a future, efficacy randomized clinical trial of CFT for people with knee osteoarthritis; and evaluate the acceptability of the CFT approach adapted from chronic low back pain to knee osteoarthritis. The secondary aim is to estimate of degree and variability of change, in selected outcomes in people undergoing CFT in comparison to usual care.

Interventions

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. Th

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.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026