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Knee Pain Phenotypes in the Community Study

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ClinicalTrials.gov Identifier: NCT02098070
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2014
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
The focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. It will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and urine biomarkers.

Condition or disease
Knee Osteoarthritis

Detailed Description:

Number of participants:

Part I: questionnaire to 40,000 people aged 40 years and over (giving an expected 10,000 respondents) Part II: 400 participants.


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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Knee Pain and Related Health in the Community Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort
Knee Pain Population
Participants who have responded to the questionnaire with self-reported pain.
Non-Knee Pain Population
Participants who have responded to the questionnaire, no self-reported pain.



Primary Outcome Measures :
  1. Knee Pain Phenotypes [ Time Frame: up to 12 months ]
    The prevalence of the different knee pain phenotypes, provided by specific pain questionnaires. This will include the Intermittent and Constant Osteoarthritis Pain Questionnaire (ICOAP), the Pain Catastrophizing Scale (PCS) and the PainDetect (for neuropathic pain).


Secondary Outcome Measures :
  1. Other Risk Factors [ Time Frame: up to 12 months ]
    The risk factors for each knee pain phenotype, including age, gender, pain elsewhere, the Hospital Anxiety and Depression Scale (HADS), the pain catastrophizing scale and presence of osteoarthritis risk factors (BMI, finger ratio (2D4D), finger nodes, knee alignment) will be determined from the questionnaires.


Biospecimen Retention:   Samples With DNA
Whole Blood Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community-derived sample
Criteria

Inclusion criteria:

  • Aged 40 years and over

Exclusion criteria:

  • Inability to give informed consent
  • Terminal or mental illness
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098070


Locations
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United Kingdom
Academic Rheumatology
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
Investigators
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Principal Investigator: Michael Doherty, MD University of Nottingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02098070     History of Changes
Other Study ID Numbers: 14018
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by University of Nottingham:
Knee Pain
Community Study
Knee Osteoarthritis
Risk Factors

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases