Cognition, Pain and Wellbeing
- Conditions
- Knee ArthritisKnee OsteoarthritisKnee Pain Chronic
- Registration Number
- NCT04620525
- Lead Sponsor
- University of Nottingham
- Brief Summary
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Cognitive functions include memory, attention, organisation and planning, task initiation, regulation of emotions and reflection of oneself and are important for everyday tasks, such as following a conversation or a story in a book or on TV, learning new things, remembering old and new information and making decisions. Good cognition predicts the risk of developing chronic pain after a painful event, such as surgery. Chronic pain patients report numerous cognitive impairments, with attention and memory being the two most prominent that can persist even after the original cause of pain has been treated. Little evidence exists regarding the nature and magnitude of these deficits and their underlying brain and psychological mechanisms in chronic knee OA. The investigators want to understand which cognitive functions and to what extent are associated with pain in patients with knee OA.
- Detailed Description
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Cognitive functions include memory, attention, organisation and planning, task initiation, regulation of emotions and reflection of oneself and are important for everyday tasks, such as following a conversation or a story in a book or on TV, learning new things, remembering old and new information and making decisions. Good cognition predicts the risk of developing chronic pain after a painful event, such as surgery. Chronic pain patients report numerous cognitive impairments, with attention and memory being the two most prominent that can persist even after the original cause of pain has been treated. Little evidence exists regarding the nature and magnitude of these deficits and their underlying brain and psychological mechanisms in chronic knee OA. The investigators want to understand which cognitive functions and to what extent are associated with pain in patients with knee OA. Identifying specific domains of cognitive function affected by chronic pain has a clinical utility; specific domains regulate certain aspects of activities of daily living, such as managing personal finances, grocery shopping, remembering to take medications and, thus, dealing with pain early in the disease course could prevent subsequent cognitive loss and long-term pain. To do this the investigators will examine the link between measures of pain and measures of cognition in people with knee OA. The investigators propose to measure knee pain, physical function, sleep quality and overall wellbeing with questionnaires and pain sensitivity measures. The investigators will measure cognition with questionnaires and computer-based tasks testing aspects of cognitive function, including memory and attention. The investigators will compare the questionnaire and pain sensitivity measures with questionnaire and measures of cognitive function in the same participants. The investigators will include tests of various aspects of a person's memory that will facilitate the establishment of which aspects are related to chronic pain. The investigators hypothesise that chronic pain is linked to specific cognitive deficits in patients with knee OA and managing pain, for example, with mild to moderate targeted exercise and healthy diet, may limit the risk of memory loss and dementia and, in turn, predict better treatment outcomes.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Aged 40 years and onward
- Able to read and write English
- Have English as their first language
- Persons who do not adequately understand verbal explanations of written information in English, or who have special communication needs or whose English is not their first language
- Dialysis patients or on home oxygen
- Terminal illness
- Serious mental illness
- Dementia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain sensitivity measures Conducted once, at assessment visit approximately 6 minutes Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as conditioned pain modulation (CPM). CPM assesses the function of endogenous pain inhibitory pathways. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Pain severity measure Conducted once, at assessment visit : approximately 5-10 minutes The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a self-administered 24 items questionnaire with three subscales assessing pain, stiffness and physical function, is an extensively utilised tool for the evaluation of hip and knee OA and will be used in the current study.
Neuropathic pain quality: PD-Q Conducted once, at assessment visit : approximately 5-10 minutes The PainDETECT Questionnaire (PD-Q) is a self-report questionnaire developed to discriminate between nociceptive and neuropathic pain. It has been further modified (mPDQ) for use among specific pain groups, for example, knee pain. Neuropathic pain symptoms as identified with the mPDQ have been found to correlate with signs of central sensitisation in OA, as identified with QST.
Cognitive function Conducted once, at assessment visit approximately 7 minutes Questionnaire cognitive measures including the Cognitive reflection test (CRT) will be used.
- Secondary Outcome Measures
Name Time Method Premorbid IQ Conducted once, at assessment visit approximately 10-15 minutes The National Adult Reading Test (NART) will serve as a measure of general premorbid IQ.
Sleep Quality: PSQI Conducted once, at assessment visit approximately 5-10 minutes Sleep disturbances are common within people experiencing chronic pain and are associated with impaired cognitive function both in males and females. For that reason, the Pittsburgh sleep quality index (PSQI) will be utilised to assess sleeping patterns in people with chronic pain.
Physical function Conducted once, at assessment visit approximately 5 minutes Functionality testing will be done using the 30-second sit to stand test (30CST)
biomarkers of insulin resistance Once pre-assessment visit Urine sample will be collected at home and handed in at attendance of the visit 5 minutes Urine samples will be collected and sent for laboratory analysis to determine biomarkers of insulin resistance
Body mass index (BMI) Conducted once, at assessment visit approximately 5 minutes Clinical assessment of body weight and height to determine BMI.
Inflammatory biomarkers Conducted once, at assessment visit approximately 5-15 minutes for blood collection. Blood samples will be collected and serum sent for laboratory analysis to determine inflammatory biomarkers using RNA tubes.
Altruism/Decision making Conducted once, at assessment visit approximately 5-10 minutes Participants will also complete a Dictator Game (DG) to explore the role of altruism in motivating subjects' behaviour in two independent settings, whereby participants will be given money (£10) and can donate some, all or none to: 1. an anonymous participant (75) and 2. a charity organisation.
Depression/Anxiety Conducted once, at assessment visit approximately 5-10 minutes The Hospital Anxiety and Depression Scale (HADS), a 14-item measure designed to assess anxiety and depression symptoms will be also used.
gut microbiome measures. Once post-assessment visit Faecal samples will be done home and sent back in prepaid envelope. 15 minutes Faecal (optional) samples will be collected and sent for laboratory analysis to determine gut microbiome measures.
Trial Locations
- Locations (1)
University of Nottingham
🇬🇧Nottingham, United Kingdom