Cognition, Pain and Wellbeing

NCT04620525 | Terminated

• 1 other identifier: 1
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis

Keywords

knee; osteoarthritis; pain

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• Cognitive function

  Questionnaire cognitive measures, including the Cognitive Failures Questionnaire (CFQ) will be used.

  Conducted once, at assessment visit approximately 8 minutes

• Cognitive function

  Questionnaire cognitive measures including the Cognitive reflection test (CRT) will be used.

  Conducted once, at assessment visit approximately 7 minutes

• 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 Outcomes (10)

• Premorbid IQ

  Conducted once, at assessment visit approximately 10-15 minutes

• Depression/Anxiety

  Conducted once, at assessment visit approximately 5-10 minutes

• Sleep Quality: PSQI

  Conducted once, at assessment visit approximately 5-10 minutes

• Physical function

  Conducted once, at assessment visit approximately 6 minutes

• Physical function

  Conducted once, at assessment visit approximately 5 minutes

Study Arms (2)

Participants with the relevant condition

Participants with the relevant condition

Healthy controls

Healthy controls

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 40 years and onward
• Able to read and write English
• Have English as their first language

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (20ml), urine and faecal samples will be retained to identify inflammatory biomarkers, biomarkers of insulin resistance and gut microbiome measures.

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana M Valdes, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: November 9, 2020
• Study Start: November 7, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

GB (1)