Cognition, Pain and Wellbeing

Knee Osteoarthritis Clinical Trial

— CPW  

Official title:

The Link Between Cognitive Function and Chronic Pain: An Observational Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04620525
• Other study ID #: 1
• Status: Terminated
• Start date: November 7, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: May 2024
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Aged 40 years and onward

• Able to read and write English

• Have English as their first language

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain sensitivity measures	Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as pressure pain threshold (PPT). PPT is a valid measure of tenderness around the knee. 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.	Conducted once, at assessment visit approximately 10 minutes
Primary	Pain sensitivity measures	Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as temporal summation (TS), TS is a measure of central sensitization. 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.	Conducted once, at assessment visit approximately 4 minutes
Primary	Pain sensitivity measures	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.	Conducted once, at assessment visit approximately 6 minutes
Primary	Pain severity measure	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.	Conducted once, at assessment visit : approximately 5-10 minutes
Primary	Cognitive function	Cambridge Neuropsychological Test Automated Battery (CANTAB) (objective measure) including tests of prefrontal-dependent sustained visual attention (Rapid Visual Information Processing, RVP, 7 min), attentional set shifting (Intra-/ Extra- Dimensional Set Shift, IED, 7 min) and hippocampus-dependent paired associate learning (Visual Learning Paired Associates Learning, PAL, 8 min) will be used. Other CANTAB tests will be included for comparison (reaction time test, RTI, 3 min; Stroop-like test, MTT, 8 min; spatial working memory test, SWM, 4 min).	Conducted once, at assessment visit : approximately 40 minutes
Primary	Cognitive function	Questionnaire cognitive measures, including the Cognitive Failures Questionnaire (CFQ) will be used.	Conducted once, at assessment visit approximately 8 minutes
Primary	Cognitive function	Questionnaire cognitive measures including the Cognitive reflection test (CRT) will be used.	Conducted once, at assessment visit approximately 7 minutes
Primary	Neuropathic pain quality: PD-Q	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.	Conducted once, at assessment visit : approximately 5-10 minutes
Secondary	Premorbid IQ	The National Adult Reading Test (NART) will serve as a measure of general premorbid IQ.	Conducted once, at assessment visit approximately 10-15 minutes
Secondary	Depression/Anxiety	The Hospital Anxiety and Depression Scale (HADS), a 14-item measure designed to assess anxiety and depression symptoms will be also used.	Conducted once, at assessment visit approximately 5-10 minutes
Secondary	Sleep Quality: PSQI	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.	Conducted once, at assessment visit approximately 5-10 minutes
Secondary	Physical function	Functionality testing will be done using the 'time up and go' (TUG) test.	Conducted once, at assessment visit approximately 6 minutes
Secondary	Physical function	Functionality testing will be done using the 30-second sit to stand test (30CST)	Conducted once, at assessment visit approximately 5 minutes
Secondary	Altruism/Decision making	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.	Conducted once, at assessment visit approximately 5-10 minutes
Secondary	Body mass index (BMI)	Clinical assessment of body weight and height to determine BMI.	Conducted once, at assessment visit approximately 5 minutes
Secondary	Inflammatory biomarkers	Blood samples will be collected and serum sent for laboratory analysis to determine inflammatory biomarkers using RNA tubes.	Conducted once, at assessment visit approximately 5-15 minutes for blood collection.
Secondary	biomarkers of insulin resistance	Urine samples will be collected and sent for laboratory analysis to determine 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
Secondary	gut microbiome measures.	Faecal (optional) samples will be collected and sent for laboratory analysis to determine gut microbiome measures.	Once post-assessment visit Faecal samples will be done home and sent back in prepaid envelope. 15 minutes