Clinical trial NCT04620525: Cognition, Pain and Wellbeing
Official title: The Link Between Cognitive Function and Chronic Pain: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Knee Arthritis
Keywords: knee
osteoarthritis
pain
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from previous studies undertaken by the Academic Rheumatology, University of Nottingham, who have expressed an interest in future research. Responders from the Investigating Musculoskeletal Health and Wellbeing cohort study (IMHWCS, n \~ 5,000) and Knee Pain and related health In the Community cohort study (KPIC, n \~ 3,000) will be sent an invitation letter and participant information sheet (PIS) with details about the Cognition, Pain and Wellbeing study. A telephone screening will be then done to confirm their eligibility for the study and their interest in participating and they will be booked an appointment for a single visit in Academic Rheumatology.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain sensitivity measures
timeFrame: Conducted once, at assessment visit approximately 10 minutes
measure: Pain sensitivity measures
timeFrame: Conducted once, at assessment visit approximately 4 minutes
measure: Pain sensitivity measures
timeFrame: Conducted once, at assessment visit approximately 6 minutes
measure: Pain severity measure
timeFrame: Conducted once, at assessment visit : approximately 5-10 minutes
measure: Cognitive function
timeFrame: Conducted once, at assessment visit : approximately 40 minutes
measure: Cognitive function
timeFrame: Conducted once, at assessment visit approximately 8 minutes
measure: Cognitive function
timeFrame: Conducted once, at assessment visit approximately 7 minutes
measure: Neuropathic pain quality: PD-Q
timeFrame: Conducted once, at assessment visit : approximately 5-10 minutes
Secondary outcomes:
measure: Premorbid IQ
timeFrame: Conducted once, at assessment visit approximately 10-15 minutes
measure: Depression/Anxiety
timeFrame: Conducted once, at assessment visit approximately 5-10 minutes
measure: Sleep Quality: PSQI
timeFrame: Conducted once, at assessment visit approximately 5-10 minutes
measure: Physical function
timeFrame: Conducted once, at assessment visit approximately 6 minutes
measure: Physical function
timeFrame: Conducted once, at assessment visit approximately 5 minutes
measure: Altruism/Decision making
timeFrame: Conducted once, at assessment visit approximately 5-10 minutes
measure: Body mass index (BMI)
timeFrame: Conducted once, at assessment visit approximately 5 minutes
measure: Inflammatory biomarkers
timeFrame: Conducted once, at assessment visit approximately 5-15 minutes for blood collection.
measure: biomarkers of insulin resistance
timeFrame: Once pre-assessment visit Urine sample will be collected at home and handed in at attendance of the visit 5 minutes
measure: gut microbiome measures.
timeFrame: Once post-assessment visit Faecal samples will be done home and sent back in prepaid envelope. 15 minutes
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Ana M Valdes, PhD
role: PRINCIPAL_INVESTIGATOR
References: