Cognition, Pain and Wellbeing

NCT ID: NCT04620525

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-07

Study Completion Date

2020-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Knee Pain Chronic Knee Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants with the relevant condition

Participants with the relevant condition

No interventions assigned to this group

Healthy controls

Healthy controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ana Valdes

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana M Valdes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nottingham

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain in Inflammatory Joint Diseases
NCT06718569 NOT_YET_RECRUITING
The Osteoarthritis Prevention Study
NCT05946044 RECRUITING NA