None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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).